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Trial record 87 of 107 for:    "Vascular Hemostatic Disease" | "Doxorubicin"

Ixazomib as a Replacement for Carfilzomib and Bortezomib for Multiple Myeloma Patients

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ClinicalTrials.gov Identifier: NCT02206425
Recruitment Status : Terminated (Data collection for endpoints have been reached)
First Posted : August 1, 2014
Last Update Posted : March 13, 2018
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
Oncotherapeutics

Brief Summary:
The goal of this clinical research study is to evaluate the safety and effectiveness (good and bad effects) of ixazomib given as part of a combination therapy to treat subjects with relapsed (subjects whose disease came back) or refractory (subjects whose disease did not respond to past treatment) multiple myeloma. More specifically, the study is focused on subjects who were previously treated with bortezomib (Velcade®) or carfilzomib (Kyprolis®) and showed worsening of their myeloma while receiving either one of these drugs in combination therapy. This study is a Phase I/II. Ixazomib is an investigational drug, which means that ixazomib is currently being tested and is not yet approved by the United States Food and Drug Administration (FDA) for subjects with relapsed or refractory multiple myeloma. Ixazomib is a new study drug that belongs to the same class as bortezomib and carfilzomib; however, unlike bortezomib and carfilzomib, ixazomib is taken by mouth. Current studies investigating ixazomib are demonstrating that it is as safe as bortezomib and effective for the treatment of multiple myeloma both on its own and in combination with other multiple myeloma medications, such as lenalidomide and dexamethasone, or prednisone and melphalan.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Melphalan Drug: Prednisone Drug: Cyclophosphamide Drug: Dexamethasone Dietary Supplement: Ascorbic acid Drug: PLD Drug: Lenalidomide Drug: Pomalidomide Phase 1 Phase 2

Detailed Description:

This is a phase 1/2, intra-patient, multicenter, open-label and non-randomized study to evaluate the efficacy and safety of ixazomib as a replacement for bortezomib or carfilzomib among multiple myeloma (MM) patients who have failed proteasome inhibitor (PI)-containing combination regimens. Patients will receive ixazomib once a week in place of bortezomib or carfilzomib in combination with an alkylating agent (melphalan or cyclophosphamide), anthracycline (pegylated doxorubicin [PLD]), immunomodulatory agent (lenalidomide, pomalidomide), ascorbic acid and/or a glucocorticosteroid (dexamethasone, prednisone or methylprednisolone) administered using the same dose(s) and schedule(s) as the last PI-containing regimen that the patients had received and failed. The total number of different prior bortezomib- or carfilzomib-containing regimens that will be evaluated is 10, reflecting those commonly used in the community as follows:

  • bortezomib + melphalan + prednisone
  • bortezomib + cyclophosphamide + ascorbic acid
  • bortezomib + cyclophosphamide + dexamethasone
  • bortezomib + PLD + dexamethasone
  • bortezomib + dexamethasone
  • carfilzomib + dexamethasone
  • bortezomib + lenalidomide + dexamethasone
  • bortezomib + pomalidomide + dexamethasone
  • carfilzomib + lenalidomide + dexamethasone
  • carfilzomib + pomalidomide + dexamethasone

This study will enroll 60 patients who are refractory to a bortezomib- or carfilzomib-containing combination regimen, as demonstrated by progressive disease (PD) while being treated, or who have relapsed within 8 weeks from the last dose of bortezomib or carfilzomib in their last PI-containing combination regimen.

Ixazomib will replace bortezomib or carfilzomib using the same PI-containing regimen the patients failed.The study will consist of: 1) a screening period; 2) up to eight 28-day treatment cycles; 3) a maintenance period; 4) a final assessment to occur 28 days after the end of the last treatment cycle; and 5) a follow-up period.

Ixazomib will be administered PO at 4 mg on Days 1, 8 and 15 of a 28-day cycle to patients enrolled in seven regimens (bortezomib + melphalan + prednisone, bortezomib + dexamethasone, carfilzomib + dexamethasone, bortezomib + lenalidomide + dexamethasone, bortezomib + pomalidomide + dexamethasone, carfilzomib + lenalidomide + dexamethasone, carfilzomib + pomalidomide + dexamethasone). Subjects on those regimens receiving 4 mg of ixazomib from the beginning of the trial will continue to do so for the length of the study, unless they suffer from adverse events requiring dose reductions. For the other three regimens, bortezomib + cyclophosphamide + dexamethasone, bortezomib + cyclophosphamide + ascorbic acid, and bortezomib + PLD + dexamethasone, the MTD for ixazomib is unknown and intra-patient dose escalation will be performed to determine the specific MTD for each of them. For these three regimens, ixazomib will be administered on Days 1, 8 and 15 of a 28-day cycle at a starting dose of 3 mg in Cycle 1, and then intra-patient dose-escalation will proceed to 4 mg in Cycle 2. All other agents will be administered at the same schedule and dose intensity as those of the last PI-containing treatment the patient failed.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Study of Ixazomib as a Replacement for Bortezomib or Carfilzomib for Multiple Myeloma (MM) Patients Recently Relapsed or Refractory to Their Last Combination Regimen Containing Either Bortezomib or Carfilzomib
Actual Study Start Date : September 2014
Actual Primary Completion Date : March 2018
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: bortezomib + melphalan + prednisone
Ixazomib will be administered PO at 4 mg on Days 1, 8 and 15 of a 28-day cycle. All other agents will be administered at the same schedule and dose intensity as those of the last PI-containing treatment the patient failed. Patients that were on a 21-day cycle schedule will follow a 28-day cycle schedule and receive ixazomib on days 1, 8 and 15. Other drugs will be administered on the same days as they were given on their prior 21-day cycle schedule, except that, in the new 28-day schedule, day 1 of other drugs will be the same as day 1 of ixazomib.
Drug: Melphalan
Melphalan will be administered at the same schedule and dose intensity as those of the last PI-containing treatment the patient failed (it varies with each patient).
Other Names:
  • Phenylalanine mustard
  • Alkeran

Drug: Prednisone
Prednisone will be administered at the same schedule and dose intensity as those of the last PI-containing treatment the patient failed (it varies with each patient).
Other Names:
  • Cortan
  • Deltasone
  • Orasone
  • Prednisone Intensol
  • Sterapred
  • Sterapred DS

Experimental: bortezomib + dexamethasone
Ixazomib will be administered PO at 4 mg on Days 1, 8 and 15 of a 28-day cycle. All other agents will be administered at the same schedule and dose intensity as those of the last PI-containing treatment the patient failed. Patients that were on a 21-day cycle schedule will follow a 28-day cycle schedule and receive ixazomib on days 1, 8 and 15. Other drugs will be administered on the same days as they were given on their prior 21-day cycle schedule, except that, in the new 28-day schedule, day 1 of other drugs will be the same as day 1 of ixazomib.
Drug: Dexamethasone
Dexamethasone will be administered at the same schedule and dose intensity as those of the last PI-containing treatment the patient failed (it varies with each patient).
Other Names:
  • Decadron
  • Dexamethasone Intensol
  • Dexpak Taperpak

Experimental: carfilzomib + dexamethasone
Ixazomib will be administered PO at 4 mg on Days 1, 8 and 15 of a 28-day cycle. All other agents will be administered at the same schedule and dose intensity as those of the last PI-containing treatment the patient failed. Patients that were on a 21-day cycle schedule will follow a 28-day cycle schedule and receive ixazomib on days 1, 8 and 15. Other drugs will be administered on the same days as they were given on their prior 21-day cycle schedule, except that, in the new 28-day schedule, day 1 of other drugs will be the same as day 1 of ixazomib.
Drug: Dexamethasone
Dexamethasone will be administered at the same schedule and dose intensity as those of the last PI-containing treatment the patient failed (it varies with each patient).
Other Names:
  • Decadron
  • Dexamethasone Intensol
  • Dexpak Taperpak

Experimental: bortezomib + lenalidomide + dexamethasone
Ixazomib will be administered PO at 4 mg on Days 1, 8 and 15 of a 28-day cycle. All other agents will be administered at the same schedule and dose intensity as those of the last PI-containing treatment the patient failed. Patients that were on a 21-day cycle schedule will follow a 28-day cycle schedule and receive ixazomib on days 1, 8 and 15. Other drugs will be administered on the same days as they were given on their prior 21-day cycle schedule, except that, in the new 28-day schedule, day 1 of other drugs will be the same as day 1 of ixazomib.
Drug: Dexamethasone
Dexamethasone will be administered at the same schedule and dose intensity as those of the last PI-containing treatment the patient failed (it varies with each patient).
Other Names:
  • Decadron
  • Dexamethasone Intensol
  • Dexpak Taperpak

Drug: Lenalidomide
Lenalidomide will be administered at the same schedule and dose intensity as those of the last PI-containing treatment the patient failed (it varies with each patient).
Other Name: Revlimid

Experimental: carfilzomib + lenalidomide + dexamethasone
Ixazomib will be administered PO at 4 mg on Days 1, 8 and 15 of a 28-day cycle. All other agents will be administered at the same schedule and dose intensity as those of the last PI-containing treatment the patient failed. Patients that were on a 21-day cycle schedule will follow a 28-day cycle schedule and receive ixazomib on days 1, 8 and 15. Other drugs will be administered on the same days as they were given on their prior 21-day cycle schedule, except that, in the new 28-day schedule, day 1 of other drugs will be the same as day 1 of ixazomib.
Drug: Dexamethasone
Dexamethasone will be administered at the same schedule and dose intensity as those of the last PI-containing treatment the patient failed (it varies with each patient).
Other Names:
  • Decadron
  • Dexamethasone Intensol
  • Dexpak Taperpak

Drug: Lenalidomide
Lenalidomide will be administered at the same schedule and dose intensity as those of the last PI-containing treatment the patient failed (it varies with each patient).
Other Name: Revlimid

Experimental: bortezomib + cyclophosphamide + dexamethasone
MTD determination. Ixazomib will be administered on Days 1, 8 and 15 of a 28-day cycle at a starting dose of 3 mg in Cycle 1, and then intra-patient dose-escalation will proceed to 4 mg in Cycle 2. All other agents will be administered at the same schedule and dose intensity as those of the last PI-containing treatment the patient failed. Patients that were on a 21-day cycle schedule will follow a 28-day cycle schedule and receive ixazomib on days 1, 8 and 15. Other drugs will be administered on the same days as they were given on their prior 21-day cycle schedule, except that, in the new 28-day schedule, day 1 of other drugs will be the same as day 1 of ixazomib.
Drug: Cyclophosphamide
Cyclophosphamide will be administered at the same schedule and dose intensity as those of the last PI-containing treatment the patient failed (it varies with each patient).
Other Names:
  • Cytoxan
  • CPM
  • CTX
  • CYT

Drug: Dexamethasone
Dexamethasone will be administered at the same schedule and dose intensity as those of the last PI-containing treatment the patient failed (it varies with each patient).
Other Names:
  • Decadron
  • Dexamethasone Intensol
  • Dexpak Taperpak

Experimental: bortezomib + cyclophosphamide + ascorbic acid
MTD determination. Ixazomib will be administered on Days 1, 8 and 15 of a 28-day cycle at a starting dose of 3 mg in Cycle 1, and then intra-patient dose-escalation will proceed to 4 mg in Cycle 2. All other agents will be administered at the same schedule and dose intensity as those of the last PI-containing treatment the patient failed. Patients that were on a 21-day cycle schedule will follow a 28-day cycle schedule and receive ixazomib on days 1, 8 and 15. Other drugs will be administered on the same days as they were given on their prior 21-day cycle schedule, except that, in the new 28-day schedule, day 1 of other drugs will be the same as day 1 of ixazomib. Due to a potential drug-drug interaction between ixazomib and ascorbic acid, patients will receive ixazomib in the clinic in the morning and will be instructed to take ascorbic acid in the evening, followed by cyclophosphamide.
Drug: Cyclophosphamide
Cyclophosphamide will be administered at the same schedule and dose intensity as those of the last PI-containing treatment the patient failed (it varies with each patient).
Other Names:
  • Cytoxan
  • CPM
  • CTX
  • CYT

Dietary Supplement: Ascorbic acid
Vitamin C will be administered at the same schedule and dose intensity as those of the last PI-containing treatment the patient failed (it varies with each patient).
Other Name: Vitamin C

Experimental: bortezomib + PLD + dexamethasone
MTD determination. Ixazomib will be administered on Days 1, 8 and 15 of a 28-day cycle at a starting dose of 3 mg in Cycle 1, and then intra-patient dose-escalation will proceed to 4 mg in Cycle 2. All other agents will be administered at the same schedule and dose intensity as those of the last PI-containing treatment the patient failed. Patients that were on a 21-day cycle schedule will follow a 28-day cycle schedule and receive ixazomib on days 1, 8 and 15. Other drugs will be administered on the same days as they were given on their prior 21-day cycle schedule, except that, in the new 28-day schedule, day 1 of other drugs will be the same as day 1 of ixazomib.
Drug: Dexamethasone
Dexamethasone will be administered at the same schedule and dose intensity as those of the last PI-containing treatment the patient failed (it varies with each patient).
Other Names:
  • Decadron
  • Dexamethasone Intensol
  • Dexpak Taperpak

Drug: PLD
Pegylated liposomal doxorubicin will be administered at the same schedule and dose intensity as those of the last PI-containing treatment the patient failed (it varies with each patient).
Other Names:
  • ATI-0918
  • doxorubicin hydrochloride liposome
  • doxorubicin hydrochloride liposome injection
  • liposomal adriamycin
  • liposomal doxorubicin
  • liposomal doxorubicin hydrochloride
  • liposome-encapsulated doxorubicin
  • pegylated doxorubicin HCl liposome
  • Pegylated Liposomal Doxorubicin
  • S-Liposomal Doxorubicin
  • Stealth Liposomal Doxorubicin
  • DOXIL
  • Dox-SL
  • Evacet
  • LipoDox

Experimental: bortezomib + pomalidomide + dexamethasone
Ixazomib will be administered PO at 4 mg on Days 1, 8 and 15 of a 28-day cycle. All other agents will be administered at the same schedule and dose intensity as those of the last PI-containing treatment the patient failed. Patients that were on a 21-day cycle schedule will follow a 28-day cycle schedule and receive ixazomib on days 1, 8 and 15. Other drugs will be administered on the same days as they were given on their prior 21-day cycle schedule, except that, in the new 28-day schedule, day 1 of other drugs will be the same as day 1 of ixazomib.
Drug: Dexamethasone
Dexamethasone will be administered at the same schedule and dose intensity as those of the last PI-containing treatment the patient failed (it varies with each patient).
Other Names:
  • Decadron
  • Dexamethasone Intensol
  • Dexpak Taperpak

Drug: Pomalidomide
Pomalidomide will be administered at the same schedule and dose intensity as those of the last PI-containing treatment the patient failed (it varies with each patient).
Other Name: Pomalyst

Experimental: carfilzomib + pomalidomide + dexamethasone
Ixazomib will be administered PO at 4 mg on Days 1, 8 and 15 of a 28-day cycle. All other agents will be administered at the same schedule and dose intensity as those of the last PI-containing treatment the patient failed. Patients that were on a 21-day cycle schedule will follow a 28-day cycle schedule and receive ixazomib on days 1, 8 and 15. Other drugs will be administered on the same days as they were given on their prior 21-day cycle schedule, except that, in the new 28-day schedule, day 1 of other drugs will be the same as day 1 of ixazomib.
Drug: Dexamethasone
Dexamethasone will be administered at the same schedule and dose intensity as those of the last PI-containing treatment the patient failed (it varies with each patient).
Other Names:
  • Decadron
  • Dexamethasone Intensol
  • Dexpak Taperpak

Drug: Pomalidomide
Pomalidomide will be administered at the same schedule and dose intensity as those of the last PI-containing treatment the patient failed (it varies with each patient).
Other Name: Pomalyst




Primary Outcome Measures :
  1. Maximum tolerated dose (MTD) for selected regimens [ Time Frame: Cycles 1-2 for selected regimens (up to 2 months) ]

    MTD determined via the number of dose-limiting toxicities (DLTs) per cohort for the following ixazomib- containing combinations:

    bortezomib+ cyclophosphamide + dexamethasone, bortezomib + cyclophosphamide + ascorbic acid, bortezomib + PLD + dexamethasone


  2. Number of subjects with adverse events [ Time Frame: up to 48 months ]
    Occurrence of adverse events throughout the study, graded via CTCAE v 4.03 criteria

  3. Overall response rate (ORR) [ Time Frame: up to 48 months ]
    Complete response (CR)+ very good partial response (VGPR) + partial response (PR), defined using IMWG criteria

  4. Clinical benefit rate (CBR) [ Time Frame: up to 48 months ]
    CBR=ORR + minor response (MR)


Secondary Outcome Measures :
  1. Time to Progression [ Time Frame: at least over 48 months ]
    Time from initiation of therapy to progressive disease

  2. Progression-free survival (PFS) [ Time Frame: at least over 48 months ]
    Time from initiation of therapy to progressive disease or death from any cause, whichever occurs first

  3. Time to response (TTR) [ Time Frame: up to 48 months ]
    Time from the initiation of therapy to the first evidence of a confirmed response

  4. Duration of response (DOR) [ Time Frame: at least over 48 months ]
    Time from the first response (> PR) to progressive disease

  5. Overall survival (OS) [ Time Frame: at least over 48 months ]
    Time from initiation of therapy to death from any cause or last follow-up visit

  6. Peripheral Neuropathy (PN) [ Time Frame: up to 48 months ]
    Incidence and severity among patients receiving ixazomib compared to their baseline PN when they entered the trial, defined by CTCAE v4.0.3 and FACT-GOG/NTX questionnaire score.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. Male or female patients 18 years or older
  2. Patients must have a diagnosis of MM, based on standard criteria as follows:

    • Major criteria:

      1. plasmacytomas on tissue biopsy
      2. bone marrow plasmacytosis (greater than 30% plasma cells)
      3. monoclonal immunoglobulin spike on serum electrophoresis IgG greater than 3.5 g/dL or IgA greater than 2.0 g/dL; kappa or lambda light chain excretion greater than 1 g/day on 24 hour urine protein electrophoresis
    • Minor criteria:

      1. bone marrow plasmacytosis (10% to 30% plasma cells)
      2. monoclonal immunoglobulin present but of lesser magnitude than given under major criteria
      3. lytic bone lesions
      4. normal IgM less than 50 mg/dL, IgA less than 100 mg/dL, or IgG less than 600 mg/dL

    Any of the following sets of criteria will confirm the diagnosis of multiple myeloma:

    • any 2 of the major criteria
    • major criterion 1 plus minor criterion 2, 3, or 4
    • major criterion 3 plus minor criterion 1 or 3
    • minor criteria 1, 2, and 3, or 1, 2, and 4
  3. Currently has progressive MM that has previously progressed or is currently progressing while receiving or within 8 weeks of receiving bortezomib or carfilzomib as part of a combination treatment. MM patients that demonstrate refractory disease, as defined below, are both eligible for enrollment provided they fulfill the other eligibility criteria:

    • Patients are refractory to a bortezomib or carfilzomib combination regimen, when they progress while currently receiving a bortezomib or carfilzomib combination treatment, or within 8 weeks of its last dose. Patients are considered relapsed, when they progress between 8 and 12-weeks from their last dose of bortezomib or carfilzomib as part of a bortezomib or carfilzomib combination therapy. Prior treatment with four days or less of a total of 400 mg of prednisone (or an equivalent potency of another steroid) for MM will not be considered a regimen.

  4. Patients that were on bortezomib-containing regimens must have been administered at least 4 doses of a minimum of 1.0 mg/m2 in no more than 28-days cycles. Subjects must have received at least one cycle meeting this definition and have shown PD to be considered eligible
  5. Patients that were on carfilzomib-containing regimens must have received at least 6 doses of at least 27 mg/m2 in no more than 28 days per cycle. Subjects must have received at least one cycle meeting this definition and have shown PD to be considered eligible
  6. Progressed from one of the specific bortezomib- or carfilzomib-containing regimens as listed on page 51. Although bortezomib- and carfilzomib-containing combination regimens that are otherwise identical except for the PI result in the same ixazomib regimen, they will be enrolled separately so that safety/efficacy can be separately determined, thereby allowing comparisons based on the prior PI that subjects were exposed to as part of the regimen that they failed (carfilzomib vs. bortezomib)
  7. Patient may have received a carfilzomib- or bortezomib-containing regimen at any time and may have received other non-proteasome inhibitor-containing intervening treatments

Key Exclusion Criteria:

  1. Patient has been diagnosed with:

    1. Plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein (M protein) and skin changes (POEMS) syndrome.3
    2. Primary amyloidosis
    3. Plasma cell leukemia
    4. Severe hypercalcemia, i.e., serum calcium = 12 mg/dL (3.0 mmol/L) corrected for albumin
  2. Diagnosed or treated for another malignancy within 3 years before study enrollment or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with non-melanomatous skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
  3. Impaired cardiac function or clinically significant cardiac diseases, including myocardial infarction within 6 months prior to enrollment, New York Heart Association (NYHA) Class II or greater heart failure, uncontrolled angina, clinically significant pericardial disease, severe uncontrolled ventricular arrhythmias, echocardiogram or multigated acquisition scan (MUGA) evidence of left ventricular ejection fraction (LVEF) below institutional normal within 28 days prior to enrollment, 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
  4. Patient has peripheral neuropathy grade 3 or higher or Grade 2 with pain on clinical examination during the screening period
  5. Patient has received the following prior therapy:

    1. Chemotherapy within 21 days of enrollment (6 weeks for nitrosoureas)
    2. Corticosteroids (>10 mg/day prednisone or equivalent) within 21 days of enrollment
    3. Immunotherapy or antibody therapy as well as thalidomide, pomalidomide, lenalidomide, arsenic trioxide, carfilzomib, or bortezomib within 21 days before enrollment
  6. Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent
  7. Known GI disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib including difficulty swallowing

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02206425


Locations
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United States, California
Comprehensive Blood and Cancer Center
Bakersfield, California, United States, 93309
John Muir Health Clinical Research Center
Concord, California, United States, 94520
California Cancer Associates for Research & Excellence (cCARE)
Encinitas, California, United States, 92024
Robert A. Moss, MD, FACP, Inc
Fountain Valley, California, United States, 92708
cCARE Fresno
Fresno, California, United States, 93720
Comprehensive Cancer Center at Desert Regional Medical Center
Palm Springs, California, United States, 92262
James Berenson, MD, Inc
West Hollywood, California, United States, 90069
United States, Florida
Cancer Specialists of North Florida
Fleming Island, Florida, United States, 32003
United States, Georgia
Lewis Hall Singletary Oncology Center
Thomasville, Georgia, United States, 31792
United States, Illinois
Oncology Specialists, SC
Niles, Illinois, United States, 60714
United States, Mississippi
Hattiesburg Clinic Hematology/Oncology
Hattiesburg, Mississippi, United States, 39401
United States, Washington
Vista Oncology
Olympia, Washington, United States, 98502
Sponsors and Collaborators
Oncotherapeutics
Takeda
Investigators
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Principal Investigator: James R Berenson, MD James R. Berenson MD, Inc.

Layout table for additonal information
Responsible Party: Oncotherapeutics
ClinicalTrials.gov Identifier: NCT02206425     History of Changes
Other Study ID Numbers: X16041
IISR-2013-M100118 ( Other Identifier: Takeda )
First Posted: August 1, 2014    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018

Keywords provided by Oncotherapeutics:
multiple myeloma
Relapsed/refractory
Ixazomib
Proteasome inhibitor
Oral

Additional relevant MeSH terms:
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Hemostatic Disorders
Doxorubicin
Liposomal doxorubicin
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Vitamins
Ascorbic Acid
Dexamethasone
Dexamethasone acetate
Prednisone
Cyclophosphamide
Lenalidomide
Bortezomib
Melphalan
Pomalidomide
Thalidomide
Ixazomib
BB 1101
Glycine