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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

    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

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  • 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

    ACP-196 (Acalabrutinib) in Combination With Pembrolizumab, for Treatment of Hematologic Malignancies

    Protocol: OSU-14272

    Eligibility:

    Inclusion Criteria:

    Diagnosis of a hematologic malignancy as documented by medical records and with

    histology based on criteria established by the World Health Organization (WHO).

    Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.

    Agreement to use contraception during the study and for 90 days after the last dose

    of ACP-196 or 120 days after the last dose of pembrolizumab, if sexually active and

    able to bear or beget children.

    Completion of all therapy (including surgery, radiotherapy, chemotherapy,

    immunotherapy, or investigational therapy) for the treatment of cancer ≥ 4 weeks

    before the start of study therapy.

    ANC ≥ 0.5 x 10^9/L or platelet count ≥ 50 x 10^9/L unless due to disease involvement

    in the bone marrow.

    Exclusion Criteria:

    A life-threatening illness, medical condition or organ system dysfunction which, in

    the investigator's opinion, could compromise the subject's safety, interfere with the

    absorption or metabolism of study drugs, or put the study outcomes at undue risk.

    Central nervous system (CNS) involvement by lymphoma/leukemia

    Any therapeutic antibody within 4 weeks of first dose of study drugs.

    Total bilirubin > 1.5 x ULN; and aspartate aminotransferase (AST) or alanine

    aminotransferase (ALT) > 3.0 x ULN.

    Estimated creatinine clearance of < 30 mL/min, calculated using the formula of

    Cockcroft and Gault (140-Age) • Mass (kg)/(72 • creatinine mg/dL); multiply by 0.85

    if female.

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  • open for enrollment

    HDAC Inhibitor AR-42 and Pomalidomide in Treating Patients with Relapsed Multiple Myeloma

    Protocol: OSU-15004

    Eligibility:

    Inclusion Criteria:

    Patients with measurable disease as defined by any of the following:

    Serum M-protein >= 0.5 g/dl (>= 500 mg/dL)

    Urine monoclonal protein >= 200 mg/24h

    Involved free light chain (FLC) level >= 10 mg/dl (>= 100 mg/l) and an abnormal serum free light chain ratio (< 0.26, or > 1.65)

    Patients must have previously received lenalidomide and a proteasome inhibitor

    Patients must be lenalidomide failures: disease progression on a prior lenalidomide-based therapy or progression within 60 days of the last dose of a lenalidomide; patients should have received at least 2 cycles of a lenalidomide-based regimen at standard doses to be evaluable for refractoriness; prior intolerance to lenalidomide does not exclude participation in the study except in cases of severe allergic reaction

    Prior radiation is permitted; however, at least 2 weeks must have elapsed since the completion of therapy and patients must have recovered from all therapy-associated toxicities to no greater than grade 1 at the time of registration; patients with symptomatic disease may receive palliative corticosteroids up to 1 week before initiating therapy

    Patient must have received 2 or more prior lines of systemic therapy for myeloma; patients must be off last treatment for at least 2 weeks (wks) by the beginning of treatment on this protocol

    Patients must have a Karnofsky performance score of 50% or greater

    Patients must have absolute neutrophil count (ANC) > 1000/uL

    Platelets >= 75,000/uL

    Total bilirubin =< 1.5 mg/dL

    Alkaline phosphatase =< 4 x institutional upper limit of normal (IULN)

    Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 3 x IULN

    Patients must have a serum creatinine limit of =< 1.5 ULN or creatinine clearance of >= 60 ml/min measured within 14 days of registration

    Prior exposure to pomalidomide or HDAC inhibitors is allowed

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

    Females of childbearing potential (FCBP) must have two negative serum or urine pregnancy tests 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) prior to study entry and for the duration of study participation; 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 female of childbearing potential (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 28 days afterwards

    Female patients must be either postmenopausal, free from menses >= 2 yrs, surgically sterilized, willing to use two adequate barrier methods of contraception to prevent pregnancy, or agree to abstain from heterosexual activity starting with screening (4 weeks prior to initiating treatment) and for 28 days after treatment, per POMALYST REMS program

    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:

    History of severe allergic reaction, including erythema nodosum, to lenalidomide

    Patients unable to receive adequate thromboprophylaxis in combination with pomalidomide

    Patients who have received investigational agents within 2 weeks or within 5 half-lives of the agent and active metabolites (whichever is longer) and who have not recovered from side effects of those therapies

    Patients with a mean QT interval corrected by Bazett's formula (QTcB) > 450 msec in males and > 470 msec in females

    Patients with known positivity for human immunodeficiency virus (HIV) or hepatitis C

    Patients with active (untreated or relapsed) central nervous system (CNS) metastasis of the patient’s myeloma

    Any other medical condition, including mental illness or substance abuse, deemed by the investigator(s) to likely interfere with the patient’s ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results

    Patients with a prior history of malignancies, other than multiple myeloma, are excluded unless the subject has been free of the disease for >= 5 years with the exception of the following non-invasive malignancies:

    Basal cell carcinoma of the skin

    Squamous cell carcinoma of the skin

    Carcinoma in situ of the cervix

    Carcinoma in situ of the breast

    Incidental histological findings of prostate cancer (T1a or T1b using the TNM [tumor, nodes, metastasis] clinical grading system) or prostate cancer that is curative

    Patients with malabsorption or any other condition that in the opinion of the principal investigator could cause difficulty in absorption of drug

    Patients that have previously progressed on pomalidomide treatment

    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: Craig C Hofmeister, MD

    Learn More
  • open for enrollment

    A Study to Determine Dose and Regimen of Durvalumab as Monotherapy or in Combination With Pomalidomide With or Without Dexamethasone in Subjects With Relapsed and Refractory Multiple Myeloma

    Protocol: OSU-15196

    Eligibility:

    Inclusion Criteria:

    Has a confirmed diagnosis of active multiple myeloma and measurable disease.

    Must have undergone prior treatment with ≥2 treatment lines of anti-myeloma therapy

    Must have failed last line of treatment (refractory to last line of treatment).

    Must have achieved at least a stable disease (SD) for at least 1 cycle of treatment

    to at least 1 prior anti-myeloma regimen before developing Progressive disease (PD)

    (relapsed)

    Prior anti-myeloma treatments must have included a lenalidomide AND proteasome

    inhibitor alone or in combination.

    Has performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG)

    Performance Scale.

    Exclusion Criteria:

    Has non-secretory or oligosecretory multiple myeloma

    Has had prior anti-myeloma therapy within 2 weeks prior to study Day 1

    Has undergone prior organ or allogeneic hematopoetic stem cell transplantation

    Has received previous therapy with pomalidomide and did not achieve at least a stable

    disease

    Has received prior therapy with an anti-programmed cell death 1 receptor (anti-PD-1),

    antiprogrammed death-ligand 1 (anti-PD-L1), antiprogrammed death-ligand 2

    (anti-PD-L2), anti-CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4

    (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically

    targeting T-cell costimulation or checkpoint pathways).

    Has received prior treatment with a monoclonal antibody within 5 half-lives of Study

    Day 1

    Has received investigational agents within 28 days or 5 half-lives (whichever is

    longer) of Study Day 1

    Has received live, attenuated vaccine within 30 days prior to Study Day 1

    Had rash ≥ Grade 3 during prior thalidomide, lenalidomide, or pomalidomide therapy

    Has a history of anaphylaxis or hypersensitivity to thalidomide, lenalidomide, POM,

    or dex

    Has peripheral neuropathy ≥ Grade 2

    Has a known additional malignancy that is progressing or requires active treatment

    (except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or

    in situ cervical cancer that has undergone potentially curative therapy).

    Is positive for human immunodeficiency virus (HIV), chronic or active hepatitis B or

    active hepatitis A or C

    Has a prior history of malignancies, other than MM, unless the subject has been free

    of the disease for ≥ 5 years (with the exception Basal cell carcinoma of the skin,

    Squamous cell carcinoma of the skin, Carcinoma in situ of the cervix, Carcinoma in

    situ of the breast, Incidental histologic finding of prostate cancer [T1a or T1b] or

    prostate cancer that is curative)

    Has clinical evidence of central nervous system (CNS) or pulmonary leukostasis,

    disseminated intravascular coagulation, or CNS multiple myeloma

    Has clinically significant cardiac disease

    Is a female who is pregnant, nursing, or breastfeeding, or who intends to become

    pregnant during the participation in the study

    Is a current smoker

    Principal Investigator: Craig C Hofmeister, MD

    Learn More
  • open for enrollment

    Daratumumab Infusion Acceleration

    Protocol: OSU-16199

    Principal Investigator: Craig C Hofmeister, MD

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  • 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