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

    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

    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

    Multicenter Study Of Natalizumab Plus Standard Steroid Treatment For High Risk Acute Graft-Versus-Host Disease

    Protocol: OSU-15270

    Eligibility:

    Inclusion Criteria: - New onset high risk acute GVHD (Ann Arbor score 3 as defined in Appendix C of the protocol) following allogeneic bone marrow transplantation. Any clinical severity (Glucksberg grade I-IV) is eligible. - Any donor type (e.g., related, unrelated) or stem cell source (bone marrow, peripheral blood, cord blood). Recipients of non-myeloablative and myeloablative transplants are eligible. - No prior systemic treatment for acute GVHD except for a maximum of 72 hours of prednisone ≤2 mg/kg/day (or IV methylprednisolone equivalent). Topical skin steroid treatment is permissible. Non-absorbable oral steroid treatment for GI GVHD is prohibited. - Age 12 years or older. - If the patient is a woman of child-bearing potential, the patient and their sexual partner must agree to practice effective contraception. - Written informed consent from patient, parent, or guardian. - Written assent from patients age 12 to 17 years. - Biopsy of acute GVHD target organ is strongly recommended, but not required. Enrollment should not be delayed for biopsy or pathology results. Patients who do not enroll within 72 hours of new onset acute GVHD are not permitted to participate. Exclusion Criteria: - Progressive or relapsed malignancy - Uncontrolled active infection - Patients with chronic GVHD - Known seropositivity for JC virus - History of Progressive Multifocal Leukoencephalopathy (PML) - Known hypersensitivity to natalizumab - Pregnant or nursing (lactating) women - Use of other drugs for the treatment of acute GVHD - Patients on dialysis - Patients requiring ventilator support - Investigational agent within 30 days of enrollment without approval from the Sponsor-Investigator

    Principal Investigator: Yvonne A Efebera, MD

    Learn More
  • open for enrollment

    Ph II Lenalidomide in Combination with Nivolumab In Patients with Relapsed/Refractory MM

    Protocol: OSU-17160

    Principal Investigator: Yvonne A Efebera, MD

    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

    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

    Wild-type Reovirus in Combination with Carfilzomib and Dexamethasone in Treating Patients with Relapsed or Refractory Multiple Myeloma

    Protocol: OSU-14031

    Eligibility:

    Inclusion Criteria:

    Patient must have relapsed or refractory myeloma that fits or did fit International Myeloma Working Group (IMWG) diagnostic criteria for symptomatic myeloma (although new or worsening end organ damage is not required to be eligible) as defined below:

    Presence of clonal bone marrow plasma cells

    Presence of serum and/or urinary measurable monoclonal protein or light chains

    Evidence of any end organ damage criteria listed below (at any time) attributed to the patient’s myeloma:

    • Hypercalcemia: serum calcium > 11.5 mg/dL or
    • Renal insufficiency: serum creatinine > 2 mg/dL
    • Anemia > 2 g/dL below the lower limit of normal or a hemoglobin value < 10 g/dL
    • Bone lesions: lytic lesions, severe osteopenia or pathologic fractures

    Patients must have measurable disease defined as any of the following:

    Serum monoclonal protein >= 500 mg/dL by protein electrophoresis

    > 200 mg of monoclonal protein in the urine on screening 24-hour electrophoresis

    Serum immunoglobulin free light chain >= 100 mg/L AND abnormal serum immunoglobulin kappa to lambda free light chain ratio

    Patients must have been previously treated with an immunomodulatory drug (IMiD) and proteasome inhibitor, must be refractory to carfilzomib defined as progression on or within 2 months of a carfilzomib-containing therapy, and must be progressing

    Prior autologous and/or allogeneic transplant is permitted although transplant must have occurred greater than 90 days prior to registration

    Both men and women of all races and ethnic groups are eligible for this study

    Prior radiation is permitted; however, at least 2 weeks must have elapsed since the completion of prior radiation therapy and patients must have recovered from all radiation-associated toxicities to no greater than grade 1 at the time of registration

    Patients with expected carfilzomib sensitive disease, Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%) is required for eligibility; those patients with lower performance status based solely on bone pain secondary to multiple myeloma are eligible

    Absolute neutrophil count (ANC) >= 1000/uL

    Platelet count >= 75,000 and transfusion independent

    Total bilirubin < 1.5 mg/dL

    Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 x the institutional upper limit of normal

    Ability to understand and the willingness to sign a written informed consent document

    Patients must be able to avoid direct contact with pregnant or nursing women, infants and immunocompromised individuals during the days of reolysin treatment and for two days after

    Patients must not have known human immunodeficiency virus (HIV) infection or active hepatitis B or C infections

    Systolic cardiac function will be assessed at screening if clinically indicated by history and physical; only patients with left ventricular ejection fraction (LVEF) >= 50% will be eligible for enrollment

    Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL prior to starting therapy and prior to beginning another cycle (if applicable)

    Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) starting 28 days prior to starting the study until at least 90 days following discontinuation of the trial therapy; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately

    A FCBP is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)

    The patient must be willing to comply with fertility requirements as below:

    Male patients must agree to use an adequate method of contraception for the duration of the study and for 90 days afterwards

    Female patients must be either postmenopausal, free from menses >= 2 years, surgically sterilized, willing to use two adequate barrier methods of contraception to prevent pregnancy, or agree to abstain from heterosexual activity starting with screening and for 90 days afterwards

    Patients must agree not to donate blood, sperm/ova during the course of taking protocol therapy and for at least 4 weeks after stopping treatment

    Exclusion Criteria:

    Patients who have had chemotherapy or radiotherapy within 2 weeks prior to entering the study; patients may be receiving concomitant therapy with bisphosphonates and low dose corticosteroids (e.g., prednisone up to but no more than 10 mg by mouth daily or its equivalent) for symptom management and comorbid conditions; doses of corticosteroid should be stable for at least 7 days prior to study treatment

    Patients who are receiving any other therapeutic investigational agents

    Patients previously treated on clinical trial with reolysin

    Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, myocardial infarction in the preceding 6 months, or psychiatric illness/social situations that would limit compliance with study requirements

    Pregnant women are excluded from this study; breastfeeding should be discontinued

    Patients with a "currently active" second malignancy that, in the opinion of the principal investigator, will interfere with patient participation, increase patient risk, shorten survival to < 1 year, or confound data interpretation

    Plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein (M-protein), and skin changes (POEMS) syndrome

    Concurrent use of complementary or alternative medicines that in the opinion of the principal investigator would confound the interpretation of toxicities and/or antitumor activity of the study drug

    Principal Investigator: Don M Benson, 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

    Stem Cell Transplant With Lenalidomide Maintenance in Patients With Multiple Myeloma (BMT CTN 0702)

    Protocol: BMT-CTN0702

    Eligibility:

    Inclusion Criteria: - Patients meeting the criteria for symptomatic multiple myeloma (MM). - Patients who are 70 years of age, or younger, at time of enrollment. - Patients who have received at least two cycles of any regimen as initial systemic therapy and are within 2 - 12 months of the first dose of initial therapy. - Cardiac function: left ventricular ejection fraction at rest greater than 40 percent. - Hepatic: bilirubin less than 1.5x the upper limit of normal and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than 2.5x the upper limit of normal. (Patients who have been diagnosed with Gilbert's Disease are allowed to exceed the defined bilirubin value of 1.5x the upper limit of normal.) - Renal: Creatinine clearance of grater than or equal to 40 mL/min, estimated or calculated. - Pulmonary: Diffusing capacity of the lung for carbon monoxide (DLCO), forced expiratory volume in one second (FEV1), or forced vital capacity (FVC) greater than 50 percent of predicted value (corrected for hemoglobin). - Patients with an adequate autologous graft defined as a cryopreserved PBSC graft containing greater than or equal to 4 x 10^6 CD34+ cells/kg patient weight. The graft may not be CD34+ selected or otherwise manipulated to remove tumor or other cells. The graft can be collected at the transplanting institution or by a referring center. The autograft must be stored so that there are two products each containing at least 2 x 10^6 CD34+ cells/kg patient weight. - Signed informed consent form. Exclusion Criteria: - Patients who never fulfill the criteria for symptomatic MM. - 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]. Patients with light chain MM detected in the serum by free light chain assay are eligible. - Patients with plasma cell leukemia. - Karnofsky performance score less than 70 percent. - Patients with greater than grade 2 sensory neuropathy (CTCAE). - Patients with uncontrolled bacterial, viral or fungal infections (currently taking medication and progression of clinical symptoms). - Patients seropositive for the human immunodeficiency virus (HIV). - Myocardial infarction within 6 months prior to enrollment or has 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 has to be documented by the investigator as not medically relevant. - Patient has hypersensitivity to bortezomib, boron or mannitol. - Patient has received other investigational drugs with 14 days before enrollment. - Patients with prior malignancies except resected basal cell carcinoma or treated cervical carcinoma in situ. Cancer treated with curative intent less than 5 years previously will not be allowed unless approved by the Protocol Officer or one of the Protocol Chairs. Cancer treated with curative intent greater than 5 years previously is allowed. - Female patients who are pregnant (positive B-HCG) or breastfeeding. - Females of childbearing potential (FCBP) or men who have sexual contact with FCBP unwilling to use contraceptive techniques during the length of lenalidomide maintenance therapy. - Prior allograft or prior autograft. - Patients who have received mid-intensity melphalan (greater than 50 mg IV) as part of prior therapy. - Patients unable or unwilling to provide informed consent. - Prior organ transplant requiring immunosuppressive therapy. - Patients with disease progression prior to enrollment. - Patients who have received lenalidomide as initial therapy for MM and have experienced toxicities resulting in treatment discontinuation. - Patients who experienced thromboembolic events while on full anticoagulation during prior therapy with lenalidomide or thalidomide. - Patients unwilling to take deep vein thrombosis (DVT) prophylaxis. - Patients who cannot undergo an intervention in any treatment arm due to a priori denial of medical costs coverage by third party payers. - Patients unable to unwilling to return to the transplant center for their assigned treatments.

    Principal Investigator: Yvonne A Efebera, MD

    Learn More