Filter Your Search

  • ?
    Participants who either do not have cancer but are at high risk for developing the disease or have had cancer and are at high risk for developing a new cancer.
  • ?
    These trials look at ways to improve the quality of life of cancer patients, especially those who have side effects from cancer and its treatment. They find new ways to help people cope with pain, nutrition problems, infection, nausea and vomiting, sleep disorders, depression and other health problems.
  • open for enrollment

    Ph I Dose Escalation & Cohort Expansion Study of TSR-042 in Pts w/ Advanced Solid Tumors

    Protocol: OSU-16293

    Principal Investigator: David M O'Malley, MD

    Learn More
  • open for enrollment

    Dendritic Cell/Myeloma Fusion Vaccine for Multiple Myeloma (BMT CTN 1401)

    Protocol: BMT-CTN1401

    Eligibility:

    Inclusion Criteria:

    Initial Inclusion Criteria:

    1. Patients must be considered transplant eligible by the treating physician at time of

    study entry.

    2. Patients must meet the criteria for symptomatic multiple myeloma prior to initiating

    systemic anti-myeloma treatment.

    3. Age >18 years and ≤ 70 years at the time of enrollment

    4. Karnofsky Performance status of ≥ 70%

    5. Patients must have > 20% plasma cells in the bone marrow aspirate differential <60

    days prior to enrollment. The required bone marrow evaluation will need to be

    repeated for patients who received more than 1 cycle of anti-myeloma therapy

    (corticosteroid with or without other anti-myeloma agents)

    6. Patients must have received < 2 cycles of systemic anti-myeloma therapy.

    7. Renal: Creatinine clearance of ≥ 40 mL/min, estimated or calculated.

    Initial Exclusion Criteria:

    1. Patients with a prior autologous or allogeneic HCT

    2. Patients with purely non-secretory MM [absence of a monoclonal protein (M protein) in

    serum as measured by electrophoresis and immunofixation and the absence of Bence

    Jones protein in the urine defined by use of conventional electrophoresis and

    immunofixation techniques and the absence of involved serum free light chain >100

    mg/L]. Patients with light chain MM detected in the serum by free light chain assay

    are eligible.

    3. Patients with Plasma Cell Leukemia

    4. Patients with High-Risk Multiple Myeloma. High-risk is defined by the presence of any

    one of the following: deletion of chromosome 13 by conventional cytogenetics,

    hypodiploidy, abnormality in chromosome 1(1q amplification or 1p deletion), t(4;14),

    t(14;16), t(14;20) or deletion of 17p by fluorescence in situ hybridization (FISH) or

    conventional karyotyping; high-risk criteria based on commercially available gene

    expression profiling (GEP) detected at any time prior to enrollment;

    5. Patients with disease progression prior to enrollment

    6. Patients seropositive for the human immunodeficiency virus (HIV).

    7. Myocardial infarction within 6 months prior to enrollment or New York Heart

    Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe

    uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute

    ischemia or active conduction system abnormalities. Prior to study entry, any ECG

    abnormality at screening will be documented by the investigator as not medically

    relevant.

    8. Patients with active clinically significant autoimmune disease, defined as a history

    of requiring systemic immunosuppressive therapy and at ongoing risk for potential

    disease exacerbation. Patients with a history of autoimmune thyroid disease, asthma,

    or limited skin manifestations are potentially eligible.

    9. Patients receiving other investigational immunotherapy or anti-myeloma drugs within

    14 days before enrollment.

    10. Patients with prior malignancies except resected basal cell carcinoma or treated

    cervical carcinoma in situ. Cancer treated with curative intent < 5 years prior to

    enrollment will not be allowed unless approved by the Protocol Officer or one of the

    Protocol Chairs. Cancer treated with curative intent > 5 years prior to enrollment is

    allowed.

    11. Female patients who are pregnant (positive beta-HCG) or breastfeeding.

    12. Females of childbearing potential (FCBP) or men who have sexual contact with FCBP

    unwilling to use contraceptive techniques (Appendix D) during the length of

    lenalidomide maintenance therapy.

    13. Patients who have received mid-intensity melphalan (>50 mg IV) as part of prior

    therapy.

    14. Prior organ transplant requiring immunosuppressive therapy.

    15. Patients who previously received lenalidomide and have experienced toxicities

    resulting in treatment discontinuation.

    16. Patients who experienced thromboembolic events while on full anticoagulation during

    prior therapy with lenalidomide or thalidomide.

    17. Patients unwilling to take deep vein thrombosis (DVT) prophylaxis.

    18. Patients unable or unwilling to provide informed consent.

    19. Patients unable or unwilling to return to the transplant center for their assigned

    treatments.

    Randomization Inclusion Criteria:

    1. Patient received transplant < 12 months of enrollment onto BMT CTN 1401.

    2. No disease progression since initiation of systemic anti-m

    Exclusion Criteria:

    Initial Inclusion Criteria:

    1. Patients must be considered transplant eligible by the treating physician at time of

    study entry.

    2. Patients must meet the criteria for symptomatic multiple myeloma prior to initiating

    systemic anti-myeloma treatment.

    3. Age >18 years and ≤ 70 years at the time of enrollment

    4. Karnofsky Performance status of ≥ 70%

    5. Patients must have > 20% plasma cells in the bone marrow aspirate differential <60

    days prior to enrollment. The required bone marrow evaluation will need to be

    repeated for patients who received more than 1 cycle of anti-myeloma therapy

    (corticosteroid with or without other anti-myeloma agents)

    6. Patients must have received < 2 cycles of systemic anti-myeloma therapy.

    7. Renal: Creatinine clearance of ≥ 40 mL/min, estimated or calculated.

    Initial Exclusion Criteria:

    1. Patients with a prior autologous or allogeneic HCT

    2. Patients with purely non-secretory MM [absence of a monoclonal protein (M protein) in

    serum as measured by electrophoresis and immunofixation and the absence of Bence

    Jones protein in the urine defined by use of conventional electrophoresis and

    immunofixation techniques and the absence of involved serum free light chain >100

    mg/L]. Patients with light chain MM detected in the serum by free light chain assay

    are eligible.

    3. Patients with Plasma Cell Leukemia

    4. Patients with High-Risk Multiple Myeloma. High-risk is defined by the presence of any

    one of the following: deletion of chromosome 13 by conventional cytogenetics,

    hypodiploidy, abnormality in chromosome 1(1q amplification or 1p deletion), t(4;14),

    t(14;16), t(14;20) or deletion of 17p by fluorescence in situ hybridization (FISH) or

    conventional karyotyping; high-risk criteria based on commercially available gene

    expression profiling (GEP) detected at any time prior to enrollment;

    5. Patients with disease progression prior to enrollment

    6. Patients seropositive for the human immunodeficiency virus (HIV).

    7. Myocardial infarction within 6 months prior to enrollment or New York Heart

    Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe

    uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute

    ischemia or active conduction system abnormalities. Prior to study entry, any ECG

    abnormality at screening will be documented by the investigator as not medically

    relevant.

    8. Patients with active clinically significant autoimmune disease, defined as a history

    of requiring systemic immunosuppressive therapy and at ongoing risk for potential

    disease exacerbation. Patients with a history of autoimmune thyroid disease, asthma,

    or limited skin manifestations are potentially eligible.

    9. Patients receiving other investigational immunotherapy or anti-myeloma drugs within

    14 days before enrollment.

    10. Patients with prior malignancies except resected basal cell carcinoma or treated

    cervical carcinoma in situ. Cancer treated with curative intent < 5 years prior to

    enrollment will not be allowed unless approved by the Protocol Officer or one of the

    Protocol Chairs. Cancer treated with curative intent > 5 years prior to enrollment is

    allowed.

    11. Female patients who are pregnant (positive beta-HCG) or breastfeeding.

    12. Females of childbearing potential (FCBP) or men who have sexual contact with FCBP

    unwilling to use contraceptive techniques (Appendix D) during the length of

    lenalidomide maintenance therapy.

    13. Patients who have received mid-intensity melphalan (>50 mg IV) as part of prior

    therapy.

    14. Prior organ transplant requiring immunosuppressive therapy.

    15. Patients who previously received lenalidomide and have experienced toxicities

    resulting in treatment discontinuation.

    16. Patients who experienced thromboembolic events while on full anticoagulation during

    prior therapy with lenalidomide or thalidomide.

    17. Patients unwilling to take deep vein thrombosis (DVT) prophylaxis.

    18. Patients unable or unwilling to provide informed consent.

    19. Patients unable or unwilling to return to the transplant center for their assigned

    treatments.

    Randomization Inclusion Criteria:

    1. Patient received transplant < 12 months of enrollment onto BMT CTN 1401.

    2. No disease progression since initiation of systemic anti-m

    Principal Investigator: Yvonne A Efebera, MD

    Learn More
  • open for enrollment

    Study of the Safety, Tolerability and Efficacy of KPT-8602 in Patients With Relapsed/Refractory Multiple Myeloma

    Protocol: OSU-15260

    Eligibility:

    Inclusion Criteria:

    Evidence of disease progression:

    Symptomatic relapsed or refractory requiring current treatment.

    Previously treated with ≥ 3 prior regimens (lines of therapy) that included at

    least one of each of the following: alkylating agent, immunomodulatory drug,

    proteasome inhibitor, and a steroid.

    Must be refractory to most recent anti-cancer regimen.

    Must have measurable disease defined by one of the following:

    Serum M-protein ≥ 0.5 g/dL by serum protein electrophoresis (SPEP) or for IgA

    myeloma, by quantitative IgA. If SPEP is felt to be unreliable for routine

    Mprotein measurement (e.g., for patients with IgA MM), then quantitative Ig

    levels by nephelometry or turbidometry are acceptable; or

    Urinary M-protein excretion at least 200 mg/24 hours; or

    Serum Free Light Chain (Serum FLC) whereby the involved light chain measures ≥

    10 mg/dL and with an abnormal ratio.

    Eastern Cooperative Oncology Group performance status of ≤ 1.

    Exclusion Criteria:

    Time since the last prior therapy:

    Radiation, chemotherapy, immunotherapy or any other anticancer therapy,

    including investigational anticancer therapy ≤ 2 weeks prior to Cycle 1 Day 1.

    Palliative steroids for disease related symptoms are allowed up to 3 days prior

    to Cycle 1 Day 1.

    Active graft versus host disease after allogeneic stem cell transplantation. At least

    3 months must have elapsed since completion of allogeneic stem cell transplantation.

    Active central nervous system malignancy. Patients who have only had prophylactic

    intrathecal or intravenous chemotherapy against central nervous system disease are

    eligible.

    Patients with significantly diseased or obstructed gastrointestinal tract or

    uncontrolled vomiting or diarrhea that could interfere with the absorption of

    KPT-8602.

    Prior exposure to XPO1 inhibitors.

    Life expectancy of ≥ 4 months.

    Principal Investigator: John L Hays, MD, PhD

    Learn More
  • open for enrollment

    Open-Label, Dose-Escalation Study of INCB054828 in Subjects With Advanced Malignancies

    Protocol: OSU-15241

    Eligibility:

    Inclusion Criteria:

    Inclusion Criteria:

    1. Male or female subjects, age 18 years or older on day of signing consent

    2. Part 1: Any advanced solid tumor malignancy; Part 2: Subjects with squamous non-small

    cell lung cancer, cholangiocarcinoma/gastric cancer, urothelial cancer,

    breast/endometrial cancer, multiple myeloma, or MPNs that have a tumor or malignancy

    that has been evaluated and confirmed to harbor genetic alterations in FGF or FGFR

    genes. A subject's fibroblast growth factor (FGF) or fibroblast growth factor

    receptor (FGFR) alteration may be based on local or central laboratory results. Part

    3: Dose finding: subjects with solid tumor malignancies who qualify for combo

    therapy; dose-expansion: FGF/FGFR+ subjects qualified to receive combo therapy

    3. Has progressed after prior therapy and there is no further effective standard

    anticancer therapy available (including subject refuses or is intolerant)

    4. Life expectancy > 12 weeks

    5. Eastern Cooperative Oncology Group (ECOG) performance status:

    Part 1: 0 or 1

    Part 2 and 3: 0, 1, or 2

    Exclusion Criteria:

    1. Treatment with other investigational study drug for any indication for any reason, or

    receipt of anticancer medications within 21 days or 5 half-lives before first dose of

    study drug

    2. Prior receipt of a selective FGFR inhibitor

    3. History of a calcium/phosphate homeostasis disorder

    4. History and/or current evidence of ectopic mineralization/calcification

    5. Current evidence of corneal disorder/keratopathy

    6. Has a history or presence of inadequate liver, renal, hematopoietic and/or cardiac

    function parameters outside protocol-defined range

    7. Prior radiotherapy within 2 weeks of study treatment

    Exclusion Criteria:

    Inclusion Criteria:

    1. Male or female subjects, age 18 years or older on day of signing consent

    2. Part 1: Any advanced solid tumor malignancy; Part 2: Subjects with squamous non-small

    cell lung cancer, cholangiocarcinoma/gastric cancer, urothelial cancer,

    breast/endometrial cancer, multiple myeloma, or MPNs that have a tumor or malignancy

    that has been evaluated and confirmed to harbor genetic alterations in FGF or FGFR

    genes. A subject's fibroblast growth factor (FGF) or fibroblast growth factor

    receptor (FGFR) alteration may be based on local or central laboratory results. Part

    3: Dose finding: subjects with solid tumor malignancies who qualify for combo

    therapy; dose-expansion: FGF/FGFR+ subjects qualified to receive combo therapy

    3. Has progressed after prior therapy and there is no further effective standard

    anticancer therapy available (including subject refuses or is intolerant)

    4. Life expectancy > 12 weeks

    5. Eastern Cooperative Oncology Group (ECOG) performance status:

    Part 1: 0 or 1

    Part 2 and 3: 0, 1, or 2

    Exclusion Criteria:

    1. Treatment with other investigational study drug for any indication for any reason, or

    receipt of anticancer medications within 21 days or 5 half-lives before first dose of

    study drug

    2. Prior receipt of a selective FGFR inhibitor

    3. History of a calcium/phosphate homeostasis disorder

    4. History and/or current evidence of ectopic mineralization/calcification

    5. Current evidence of corneal disorder/keratopathy

    6. Has a history or presence of inadequate liver, renal, hematopoietic and/or cardiac

    function parameters outside protocol-defined range

    7. Prior radiotherapy within 2 weeks of study treatment

    Principal Investigator: Sameek Roychowdhury, MD, PhD

    Learn More
  • open for enrollment

    Ph II Placebo Controlled Mntnance Ixazomib after Allogeneic HSCT for High Risk Multiple Myeloma

    Protocol: BMT-CTN1302

    Principal Investigator: Yvonne A Efebera, MD

    Learn More
  • open for enrollment

    Ixazomib, Lenalidomide, and Dexamethasone as Consolidation Therapy Followed by Maintenance Ixazomib or Lenalidomide after Stem Cell Transplant in Treating Patients with Multiple Myeloma

    Protocol: OSU-15045

    Eligibility:

    Inclusion Criteria:

    Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care

    Histologically confirmed diagnosis of symptomatic multiple myeloma; (patients with multiple myeloma with secondary amyloidosis are eligible)

    Received at least two cycles of any regimen as initial systemic therapy for multiple myeloma and are within 2-12 months of the first dose of initial therapy

    Eastern Cooperative Oncology Group (ECOG) performance status and/or other performance status 0, 1, or 2

    Absolute neutrophil count (ANC) >= 1,000/mm^3

    Platelet count >= 75,000/mm^3; platelet transfusions to help patients meet eligibility criteria are not allowed within 7 days before study enrollment

    Total bilirubin =< 1.5 x the upper limit of the normal range (ULN)

    Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x ULN

    Calculated creatinine clearance >= 30 mL/min

    Women of childbearing potential must follow pregnancy testing requirements as outlined in the Revlimid Risk Evaluation and Mitigation Strategy (REMS) program material; this is defined as either committing to continued abstinence from heterosexual intercourse or beginning TWO acceptable methods of contraception (one highly effective method and one additional effective method AT THE SAME TIME) at least 28 days prior to the start of lenalidomide, for the duration of study participation, and for 28 days following the last dose of lenalidomide; women of childbearing potential must also agree to ongoing pregnancy testing

    Men must agree to use a latex condom during sexual contact with a woman of childbearing potential even if they have had a successful vasectomy; all patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure; should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately

    All study participants must be registered into the mandatory Revlimid REMS program and be willing to comply with its requirements; per standard Revlimid REMS program requirements, all physicians who prescribe lenalidomide for research subjects enrolled into this trial, must be registered in, and must comply with, all requirements of the Revlimid REMS program

    Exclusion Criteria:

    Female patients who are lactating or have a positive serum pregnancy test during the screening period

    Evidence of MM disease progression from time of ASCT day 0

    History of > 1 prior stem cell transplantation, including tandem autologous transplantation

    History of plasma cell leukemia or MM central nervous system (CNS) involvement

    Administration or planned administration of any other concomitant chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy which would be considered a treatment of multiple myeloma from time of ASCT (following neutrophil engraftment) through discontinuation from study. Patients may be on corticosteroids if they are being given for disorders other than multiple myeloma (e.g., adrenal insufficiency, rheumatoid arthritis, etc.)

    Any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol

    Prior organ transplant requiring immunosuppressive therapy

    Active hepatitis A, B, or C virus infection, or known human immunodeficiency virus (HIV) positive

    Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent

    Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib

    Concurrent hematologic or non-hematologic malignancy requiring treatment (other than multiple myeloma and secondary amyloidosis)

    Cardiac syncope, uncompensated New York Heart Association (NYHA) class 3 or 4 congestive heart failure, myocardial infarction within the previous 6 months, unstable angina pectoris, clinically significant repetitive ventricular arrhythmias despite antiarrhythmic treatment, severe orthostatic hypotension, or clinically important autonomic disease

    Grade >= 3 peripheral neuropathy, or grade 2 with pain on clinical examination during the screening period

    Major surgery within 14 days prior to start of study treatment

    Infection requiring systemic antibiotic therapy or other serious infection within 14 days prior to start of study treatment

    Participation in other clinical trials, including those with other investigational agents not included in this trial, within 30 days prior to start of study treatment and throughout the duration of this trial

    Principal Investigator: Yvonne A Efebera, MD

    Learn More
  • open for enrollment

    Ph II, D-RVd Vs RVd W/ Newly Diagnosed MM for High-Dose Chem and Autologous Stem Cell Transplantatio

    Protocol: OSU-16218

    Principal Investigator: Yvonne A Efebera, MD

    Learn More
  • open for enrollment

    Romidepsin and Pegylated Liposomal Doxorubicin Hydrochloride in Treating Patients with Stage IB-IVB Relapsed or Refractory T-cell Lymphomas

    Protocol: OSU-14287

    Eligibility:

    Inclusion Criteria:

    Able to understand and voluntarily sign an informed consent form

    Able to adhere to the study visit schedule and other protocol requirements

    Biopsy-proven, measurable, stage IB-IVB relapsed or refractory cutaneous T-cell lymphoma after 2 lines of skin-directed therapy or one prior line of systemic therapy (Note: extracorporeal photopheresis will be considered a systemic therapy for this study)

    Patients with large cell transformation of cutaneous T cell lymphoma are eligible

    Patients with systemic T cell lymphoma of any stage and any subtypes; patient must have had at least one standard chemotherapy and measurable disease at the time of enrollment

    Patients with systemic T cell lymphomas who relapsed after autologous transplant are eligible

    Patients with prior treatment of histone deacetylase (HDAC) inhibitors or doxorubicin liposome or doxil are eligible

    All cancer therapy, including radiation, topical steroid, and chemotherapy, must have been discontinued at least 1 week or 3 half-lives whichever is the longest prior to treatment in this study; the only exceptions are participants who are symptomatic from their skin lesions and have been on corticosteroids for prolonged periods of time (> 60 days) without change may continue use of either systemic steroid (equivalent to =< 10 mg per day of prednisone) or topical steroids are eligible for this study if the frequency and dosage steroids has not changed for 60 days prior to the study; these participants should continue on the same dose of systemic/topical steroid throughout the study period unless they achieve a complete response at which time steroids can be discontinued

    Patients are allowed to continue any medications with known activity in T cell lymphomas at the pre-enrollment doses for conditions other than T cell lymphomas (i.e., steroids for sarcoidosis), as long as there is evidence of T cell lymphoma progression while patients were on these agents

    Eastern Cooperative Oncology Group (ECOG) performance status of =< 2 at study entry

    Absolute neutrophil count >= 750/mm^3

    Platelet count >= 75,000/mm^3

    Total bilirubin =< 2 x upper limit of normal (ULN)

    Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 x ULN

    Calculated creatinine clearance >= 30 ml/min (by the Cockcroft-Gault equation)

    Disease free of prior malignancies for >= 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix or breast; patients with early stage of prostate cancer under clinical surveillance without therapy are eligible

    Negative serum pregnancy test at the time of enrollment for females of childbearing potential

    For males and females of child-producing potential, use of effective contraceptive methods during the study to include 2 methods of contraception, one being a condom

    Life expectancy >= 90 days

    Exclusion Criteria:

    Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form

    Pregnant or breast feeding females

    Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study

    Prior allogeneic hematopoietic cell transplant

    Prior solid organ transplant

    Cumulative anthracycline exposure greater than 450 mg/m^2 doxorubicin equivalents prior to enrollment

    Known active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV); patients who are seropositive because of prior hepatitis B virus vaccination are eligible

    Any active central nervous system or meningeal involvement

    Congenital long QT syndrome

    Baseline corrected QT (QTc) interval >= 480 milliseconds

    Myocardial infarction within 6 months of course 1 day 1 (C1D1); subjects with a history of myocardial infarction between 6 and 12 months prior to C1D1 who are asymptomatic and have had a negative cardiac risk assessment (treadmill stress test, nuclear medicine stress test, or stress echocardiogram) since the event may participate

    Other significant electrocardiogram (ECG) abnormalities including 2nd degree atrio-ventricular (AV) block type II, 3rd degree AV block, or bradycardia (ventricular rate less than 50 beats/min)

    Symptomatic coronary artery disease (CAD), e.g., angina Canadian class II-IV; in any patient in whom there is doubt, the patient should have a stress imaging study and, if abnormal, angiography to define whether or not CAD is present

    An ECG recorded at screening showing evidence of cardiac ischemia (ST depression of >= 2 mm, measured from isoelectric line to the ST segment); if in any doubt, the patient should have a stress imaging study and, if abnormal, angiography to define whether or not CAD is present

    Congestive heart failure (CHF) that meets New York Heart Association (NYHA) class II to IV definitions and/or ejection fraction < 40% by multigated acquisition (MUGA) scan or < 50% by echocardiogram and/or magnetic resonance imaging (MRI)

    A known history of sustained ventricular tachycardia (VT), ventricular fibrillation (VF), Torsade de Pointes, or cardiac arrest unless currently addressed with an automatic implantable cardioverter defibrillator (AICD)

    Hypertrophic cardiomegaly or restrictive cardiomyopathy from prior treatment or other causes

    Uncontrolled hypertension, i.e., blood pressure (BP) of >= 160/95; patients who have a history of hypertension controlled by medication must be on a stable dose (for at least one month) and meet all other inclusion criteria; or

    Any cardiac arrhythmia requiring an anti-arrhythmic medication (excluding stable doses of beta-blockers)

    Any cardiac finding that is deemed ineligible at the discretion of the investigator

    Patients taking drugs leading to significant QT prolongation and unable to stop drugs prior to treatment

    Concomitant use of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors or inducers unless able to stop medication(s) prior to starting study therapies

    Learn More
  • open for enrollment

    Phase III Comparing Conventional Dose RVD to High-Dose w PSCT in Initial Management of Myeloma

    Protocol: OSU-14069

    Eligibility:

    Inclusion Criteria:

    Participants must have a diagnosis of MM, according to International Myeloma Foundation 2003 Diagnostic Criteria; according to these criteria, the following must be met:

    Monoclonal plasma cells in the bone marrow; 10% (or proven plasmocytic infiltration in bone marrow biopsy) and/or presence of a biopsy-proven plasmacytoma within 35 days of initiation of protocol therapy

    Monoclonal protein (M-protein) present in the serum and/or urine

    Myeloma-related organ dysfunction (1 or more) of the following; a variety of other types of end-organ dysfunctions can occasionally occur and lead to a need for therapy; Note: laboratory assessments used to support the calcium, kidney (renal) failure, anemia, bone lesions (CRAB) criteria in the International Myeloma Foundation (IMF) 2003 Diagnostic Criteria of MM are performed at the time of diagnosis; these assessments are not required to be performed within the 21 days of initiation of protocol therapy

    • [C] Calcium elevation in the blood, defined as serum calcium > 10.5 mg/dl or upper limit of normal
    • [R] Renal insufficiency (defined as serum creatinine above normal)
    • [A] Anemia, defined as hemoglobin < 10 g/dl or 2 g < normal
    • [B] Lytic bone lesions or osteoporosis; if a solitary (biopsy-proven) plasmacytoma or osteoporosis alone (without fractures) are the sole defining criteria, then; 30% plasma cells are required in the bone marrow or proven plasmocytic infiltration in bone/bone marrow biopsy

    Note: these criteria identify stage IB (if the creatinine is > 2 mg/dl at presentation) and stages II and III A/B myeloma by Durie-Salmon stage; stage IA becomes smoldering or indolent myeloma

    Participants must have documented symptomatic myeloma, with organ damage related to myeloma as defined above with laboratory assessments

    Participants must have myeloma that is measurable by either serum or urine evaluation of the monoclonal component or by assay of serum free light chains; measurable disease is defined as one or more of the following: serum M-protein >= 1 g/dl (except patients with immunoglobulin [Ig] D or IgA myeloma), urine M-protein >= 200 mg/24 hour (h), and/or serum free light chain (FLC) assay: involved FLC level >= 10 mg/dl with abnormal serum FLC ratio; for patients with IgD or IgA myeloma, a serum M-protein of greater than or equal to 0.5 g/dl will suffice; free light chain patients not measurable by urine or serum evaluation may be considered for inclusion

    Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)

    Negative human immunodeficiency virus (HIV) blood test within 21 days of study entry; HIV-positive individuals on combination antiretroviral therapy are ineligible

    All study participants must be registered into the mandatory Revlimid Risk Evaluation and Mitigation Strategy (REMS®) program, and be willing and able to comply with the requirements of Revlimid REMS®

    Females of childbearing potential* must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 – 14 days and again within 24 hours prior to prescribing lenalidomide for cycle 1 (prescriptions must be filled within 7 days as required by Revlimid REMS®) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide

    A female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or 2) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time during the preceding 24 consecutive months)

    Females of childbearing potential must also agree to ongoing pregnancy testing

    Men must agree to use a latex condom during sexual contact with a female of childbearing potential even if they have had a successful vasectomy

    Ability to understand and the willingness to sign a written informed consent document; voluntary written informed consent must be obtained before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care

    Exclusion Criteria:

    Participant treated with any prior systemic therapy for myeloma; treatment by localized radiotherapy is not an exclusion criterion if an interval of at least 7 days between the end of radiotherapy and initiation of protocol therapy is observed; intervals of less than 7 days between radiotherapy and initiation of protocol therapy will be considered on a case by case basis with the lead principal investigator (PI), provided toxicity is not a concern; similarly, the dose of corticosteroids received by the participant as part of initial therapy for myeloma should not exceed the equivalent of 160 mg of dexamethasone over a two-week period before initiation of protocol therapy

    Primary amyloidosis (AL) or myeloma complicated by amyloidosis

    Participants receiving any other investigational agents

    Participants with known brain metastases should be excluded from this clinical trial

    Poor tolerability or known allergy to any of the study drugs or compounds of similar chemical or biologic composition to lenalidomide, bortezomib and/or dexamethasone

    Participants with platelet level < 50,000/mm^3, within 21 days of initiation of protocol therapy for patients in whom < 50% of bone marrow nucleated cells are plasma cells; or platelet count < 30,000/mm^3 for patients in whom >= 50% of bone marrow nucleated cells are plasma cells; transfusion within 7 days of screening is not allowed to meet platelet eligibility criteria

    Participants with an absolute neutrophil count (ANC) < 1000/mm^3, within 21 days of initiation of protocol therapy; growth factor within 7 days of screening is not allowed to meet ANC eligibility criteria

    Participants with hemoglobin level < 8 g/dL, within 21 days of initiation of protocol therapy; transfusion may be used to meet hemoglobin eligibility criteria

    Total bilirubin > 1.5 x institutional upper limit of normal (ULN) (patients with benign hyperbilirubinemia [e.g., Gilbert’s syndrome] are eligible), within 21 days of initiation of protocol therapy

    Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]), or alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) >= 2 x institutional ULN, within 21 days of initiation of protocol therapy

    Alkaline phosphatase >= 2 x institutional ULN, within 21 days of initiation of protocol therapy

    Renal insufficiency at the time of screening, defined as serum creatinine > 2.0 mg/dL or creatinine clearance < 50 mL/min (either actual or calculated value may be used), within 21 days of initiation of protocol therapy; creatinine clearance will be the primary eligibility criteria in determining renal insufficiency; the Cockcroft-Gault formula should be used for calculating creatinine clearance values

    Respiratory compromise, defined as ventilation tests with diffusion capacity of the lung for carbon monoxide (DLCO) < 50%

    Participant with clinical signs of heart or coronary failure, or evidence of left ventricular ejection fraction (LVEF) < 40%; participant with myocardial infarction within 6 months prior to enrollment or have New York Heart Association (NYHA) class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conductive system abnormalities; prior to study entry, any electrocardiogram (ECG) abnormality at screening has to be documented by the investigator as not medically relevant

    Intercurrent illness including, but not limited to ongoing or active severe infection, known infection with hepatitis B or C virus, poorly controlled diabetes, severe uncontrolled psychiatric disorder or psychiatric illness/social situations that would limit compliance with study requirements; for patients with a positive hepatitis B antibody result, but no signs of active infection, participating sites must contact the study PI for approval

    Participants with previous history of another malignant condition are excluded, except for localized cancers that have been adequately treated; this includes completely resected basal cell carcinoma or squamous cell carcinoma of the skin, in situ malignancy (e.g. ductal carcinoma in situ [DCIS] of the breast), good risk prostate cancer after curative therapy and/or considered appropriate for watchful waiting (e.g. Gleason 6 or less, T2 or less and prostate-specific antigen [PSA] < 10) , and stage I cervical cancer; if invasive malignancy was experienced 2 or more years ago and confirmed as cured, these participants may be considered for the study on case by case basis with PI discussion and approval

    Female participants pregnant or breast-feeding; pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with lenalidomide; these potential risks may also apply to other agents used in this study; lactating females must agree not to breast feed while taking lenalidomide

    Inability to comply with an anti-thrombotic treatment regimen (e.g., administration of aspirin, enoxaparin, or low molecular weight heparin administration [type Innohep or equivalent])

    Peripheral neuropathy >= grade 2 on clinical examination, within 21 days of initiation of protocol therapy

    Principal Investigator: Yvonne A Efebera, MD

    Learn More