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    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.
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    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

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  • 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

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  • 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

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  • open for enrollment

    Pomalidomide and Dexamethasone with or without Ixazomib in Treating Patients with Refractory Multiple Myeloma

    Protocol: ALLIANCE-A061202

    Eligibility:

    Inclusion Criteria:

    Histologically confirmed diagnosis of symptomatic multiple myeloma; relapsed disease is myeloma that has previously responded to prior therapy (MR or better) and subsequently progressed

    Measurable disease

    Serum myeloma protein (M-protein) >= 1.0 g/dL (>= 0.5 g/dL for immunoglobulin A [IgA] myeloma) and/or

    Urine M-protein >= 200 mg/24 hours and/or

    Involved serum free light chain level >= 10 mg/dL AND an abnormal serum free light chain ratio and/or

    Baseline marrow burden of myeloma of at least 30%

    Please note: for patients participating in the phase II portion of the study who elect to cross-over from treatment Arm 1 to treatment Arm 2 at the time of disease progression, the serum M protein should be 0.5 g/dL or more if that is the parameter being followed to measure response

    Previously treated symptomatic multiple myeloma

    Lenalidomide AND proteasome inhibitor-refractory multiple myeloma (dual refractory disease):

    Please note: lenalidomide and proteasome inhibitor-refractory disease is defined as disease progression on or progression within 60 days of the last dose of a lenalidomide- AND proteasome inhibitor-based treatment; patients should have received at least 2 cycles of a lenalidomide- or proteasome inhibitor-based regimen at standard doses to be evaluable for refractoriness; patients can be refractory to any proteasome inhibitor–they do NOT need to be refractory to all available proteasome inhibitors; in addition, patients can be refractory to lenalidomide and proteasome inhibitors given sequentially as part of different lines of therapy OR therapy that includes a combination of lenalidomide and a proteasome inhibitor; please see the International Myeloma Working Group (IMWG) response criteria for progressive disease (PD)

    At least 2 or more prior lines of systemic therapy for multiple myeloma

    Please note: a line of therapy for myeloma is defined as 1 or more planned cycles of single agent or combination therapy, as well as a planned series of treatment regimens administered in a sequential manner (e.g. lenalidomide, bortezomib and dexamethasone induction therapy for 4 cycles followed by autologous stem cell transplantation and then lenalidomide maintenance therapy would be considered 1 line of prior therapy); a new line of therapy begins when a planned therapy is modified to include other treatment agents (alone or in combination) as a result of disease progression, disease relapse or treatment-related toxicity (e.g. a patient is progressing in the face of lenalidomide maintenance therapy and has bortezomib and dexamethasone added into their regimen); a new line of therapy also begins when a planned treatment-free interval is interrupted by the need to start treatment due to disease relapse/progression (e.g. a patient with relapsed myeloma achieves a partial response after a planned 8 cycles of cyclophosphamide, bortezomib and dexamethasone, enjoys an 8-month period off therapy but then experiences disease progression requiring re-initiation of therapy)

    Allogeneic stem cell transplantation is allowed provided the patient is >= 1 year from transplant, is not on immunosuppressive therapy to treat/prevent graft-versus-host disease, has no evidence of active graft versus host disease, no evidence of active infection and meets all other criteria for participation

    No other chemotherapy or radiation therapy within 14 days prior to registration

    No investigational agent within 21 days prior to registration

    Pomalidomide naive and pomalidomide sensitive disease are allowed during phase I and phase II

    Please note: Sensitivity to pomalidomide is defined as an MR or better to prior pomalidomide-based therapy that is maintained for >= 60 days from the last dose of therapy

    No concurrent investigational therapy

    No major surgery within 28 days prior to registration

    Patients cannot have received G-CSF (filgrastim) or GM-CSF (sargramostim) within 1 week of screening or pegfilgrastim within 2 weeks of screening to meet eligibility criteria

    Patients cannot have received a platelet transfusion within 7 days of screening to meet eligibility criteria; red blood cell transfusions are allowed at any time

    Non-pregnant and non-nursing:

    A female of childbearing potential is a sexually mature female who:

    • Has not undergone a hysterectomy or bilateral oophorectomy; or
    • 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); please note the information below is strictly for eligibility purposes

    Therefore, women of childbearing potential must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mlU/ml no more than 14 days prior to therapy and repeated again within 24 hours of starting pomalidomide and must either commit to complete abstinence from heterosexual contact or begin TWO acceptable methods of birth control, one highly effective method and one additional effective (barrier) method, AT THE SAME TIME, before starting pomalidomide; females of childbearing potential must also agree to ongoing pregnancy testing; men must practice complete abstinence or agree to use a condom during sexual contact with a female of childbearing potential even if they have had a successful vasectomy; all participants must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure; participating women cannot be pregnant or nursing

    Eastern Cooperative Oncology Group (ECOG) performance status 0-2

    Absolute neutrophil count (ANC) >= 1.0 x 10^9/L

    Platelet count >= 50 x 10^9/L

    Calculated (Calc.) creatinine clearance >= 50 mL/min; calculated utilizing the Cockcroft-Gault formula or 24-hour urine collection

    Total bilirubin < 1.5 x upper limits of normal (ULN)

    Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 x upper limits of normal (ULN)

    Patients cannot have:

    Central nerve system involvement

    Primary refractory multiple myeloma

    • Note: primary refractory multiple myeloma is defined as disease that is nonresponsive-patients who have never achieved an MR or better-with any therapy over the course of their disease; it includes patients who never achieve MR or better in whom there is no significant change in M-protein and no evidence of clinical progression as well as patients who meet criteria for true progressive disease (PD)

    Primary or secondary plasma cell leukemia

    Light-chain (AL) amyloidosis or polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome

    Patients cannot have:

    Known active hepatitis C based on:

    +Hepatitis C virus (HCV) antibody (confirmed)

    +HCV ribonucleic acid (RNA)

    Liver disease with history of positive serology

    Known hepatitis B surface antigen positivity

    Patients cannot have had previous hypersensitivity to any of the components of the study treatment

    Patients cannot have had a prior history of erythema multiforme with thalidomide or lenalidomide treatment

    =< Grade 2 peripheral neuropathy

    Adequate cardiac function, defined as:

    No electrocardiogram (EKG) evidence of acute ischemia

    No EKG evidence of active, clinically significant conduction system abnormalities

    No EKG evidence of > grade 2 (> 480 ms) corrected QT (QTc) prolongation

    Prior to study entry, any EKG abnormality at screening not felt to put the patient at risk has to be documented by the investigator as not medically significant

    No uncontrolled angina or severe ventricular arrhythmias

    No clinically significant pericardial disease

    No history of myocardial infarction within the last 6 months

    No class 3 or higher New York Heart Association congestive heart failure

    Patients cannot be on strong inducers of cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) or cytochrome P450 family 1, subfamily A, polypeptide 2 (CYP1A2) or strong inhibitors of CYP3A4 or CYP1A2

    Note: Ixazomib is a substrate of CYP3A4 and CYP1A2

    Chronic concomitant treatment with strong CYP3A4 inducers is not allowed (e.g. phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, and St. John’s Wort); please note that drugs that strongly induce or inhibit CYP3A4 are not allowed; because the lists of these agents are constantly changing, it is important to regularly consult a frequently updated list such as http://medicine.iupui.edu/clinpharm/ddis/; medical reference texts such as the Physicians’ Desk Reference may also provide this information; as part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product

    Patients with human immunodeficiency virus (HIV) infection are eligible, provided they meet the following:

    No history of acquired immunodeficiency syndrome (AIDS)-defining conditions or other HIV related illness

    Cluster of differentiation (CD)4+ cells nadirs > 350/mm^3

    Treatment sensitive HIV and, if on anti-HIV therapy, HIV viral load < 50 copies/mm^3

    Please note: HIV+ patients who enroll on this study and are assigned to treatment with ixazomib may need to modify their anti-retroviral therapy prior to receiving protocol therapy if they are on strong inducers or potent inhibitors of cytochrome P450 3A4

    Principal Investigator: Yvonne A Efebera, MD

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  • 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

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  • 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

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  • open for enrollment

    Ph I Study of ACTR087 in Combo w/ SEA-BCMA in Subjects w/ Relapsed or Refractory Multiple Myeloma

    Protocol: OSU-17279

    Principal Investigator: Don M Benson, MD, PhD

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  • 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: Ashley Rosko, MD

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  • 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

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