Study of Oral IXAZOMIB in Combination With Lenalidomide and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01383928
First received: June 27, 2011
Last updated: November 16, 2015
Last verified: November 2015

June 27, 2011
November 16, 2015
October 2011
April 2015   (final data collection date for primary outcome measure)
  • Phase 1: Maximum Tolerated Dose (MTD) [ Time Frame: Cycle 1 ] [ Designated as safety issue: Yes ]
    MTD was highest dose of ixazomib given with combination drugs, at which <=1 of 6 participants experienced dose-limiting toxicity (DLT) during Cycle 1 of Phase 1. DLT defined as any of following considered possibly related to therapy: Grade 4 neutropenia (absolute neutrophil count [ANC] <500 cell per cubic millimeter [cells/mm^3]) for >7 days; Grade 3 neutropenia with fever or infection; Grade 4 thrombocytopenia for >7 days; Grade 3 thrombocytopenia with clinically significant bleeding; platelet count <10,000/mm^3; Grade 2 peripheral neuropathy with pain or >=Grade 3 peripheral neuropathy; >=Grade 3 nausea/emesis, diarrhea controlled by supportive therapy; any >=Grade 3 nonhematologic toxicity except Grade 3 arthralgia/myalgia; or <1 week Grade 3 fatigue; delay in initiation of the subsequent therapy cycle by >14 days; <=80% lenalidomide doses administered due to other >=Grade 2 combination study drug-related nonhematologic toxicities requiring therapy discontinuation.
  • Phase 1: Recommended Phase 2 Dose (RP2D) [ Time Frame: Cycle 1 up to Cycle 35 ] [ Designated as safety issue: No ]
    The RP2D of ixazomib was determined after the evaluation of the available data from the phase 1 portion of the trial which included, but was not limited to analyses of efficacy results, toxicity characterization, all grades peripheral neuropathy, and treatment discontinuation.
  • Phase 1: Percentage of Participants Experiencing 1 or More Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs) [ Time Frame: Baseline up to 30 days after last dose of study drug ] [ Designated as safety issue: Yes ]
    An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.
  • Phase 1: Number of Participants With Change From Baseline Value in Clinical Laboratory Test Results to Worst Value [ Time Frame: Baseline and Cycle 1 up to Cycle 35 ] [ Designated as safety issue: Yes ]
    Number of participants with any markedly abnormal standard safety laboratory values collected throughout study. Hematology (white blood cell [WBC] count, lymphocytes, neutrophils, platelets, hemoglobin), clinical chemistry and urinalysis were performed. Number of participants with baseline laboratory values as per National Cancer Institute Common Terminology Criteria (NCI CTC) grade (Grade 0= within normal limits, Grade 1=Mild, Grade 2=Moderate, Grade 3= Severe, Grade 4= Life-threatening) and corresponding changes to the worst CTC grade were presented. Baseline value defined as value collected at time closest to, but prior to, first dose of study drug on Cycle 1 Day 1. Worst post-baseline value defined as worst value between first dose of any study drug and End of Study (EOS) visit. Shift to low refers to lower than Baseline value; shift to high refers to higher than baseline value for corrected calcium, glucose, magnesium, potassium and sodium irrespective of change in the CTC grade.
  • Phase 1: Number of Participants With Treatment-Emergent Adverse Events (TEAE) Related to Neurotoxicity [ Time Frame: Baseline up to 30 days after last dose of study drug ] [ Designated as safety issue: Yes ]
    TEAE related to neurotoxicity grading based on common terminology criteria for adverse events (CTACE) version 4.03 are reported. Grade 1= mild; Grade 2= moderate; within normal limits, Grade 3= severe or medically significant but not immediately life-threatening; Grade 4= life-threatening consequences; urgent intervention indicated; Grade 5= death.
  • Phase 1: Number of Participants With Clinically Significant Change From Baseline in Vital Signs [ Time Frame: Baseline and Day 1 of each treatment cycle up to 35 treatment cycles ] [ Designated as safety issue: Yes ]
    Vital signs included body temperature, blood pressure and heart rate.
  • Phase 2: Percentage of Participants With Complete Response (CR) + Very Good Partial Response (VGPR) [ Time Frame: Baseline up to treatment cycle 35 ] [ Designated as safety issue: No ]
    CR as per International Myeloma Working Group (IMWG) uniform criteria is defined as negative immunofixation on the serum and urine and disappearance of soft tissue plasmacytomas and <5% plasma cells in bone marrow. VGPR as per IMWG criteria is defined as serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100 mg per 24 hours. VGPR was applicable only to participants who had measurable disease defined by at least 1 of the following 3 measurements: Serum M-protein greater than or equal to (>=)1 g/dL; Urine M-protein >=200 mg/24 hours; Serum FLC assay level >=10 mg/dL, provided serum FLC ratio was abnormal.
  • Phase 2: Percentage of Participants With Grade 3 or Higher Adverse Events [ Time Frame: Baseline up to 30 days after last dose of study drug ] [ Designated as safety issue: Yes ]
    An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. As per Common Terminology Criteria for Adverse Events v4.0 (CTCAE), Grade 3 = AE with severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4 = AE with life-threatening consequences; urgent intervention indicated and Grade 5 = Death related to AE.
  • Phase 2: Percentage of Participants Experiencing Serious Adverse Events [ Time Frame: Baseline up to 30 days after last dose of study drug ] [ Designated as safety issue: Yes ]
    A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event.
  • Phase 2: Percentage of Participants With Treatment-Emergent Adverse Events Resulting in Study Drug Discontinuation [ Time Frame: Baseline up to 30 days after last dose of study drug ] [ Designated as safety issue: Yes ]
    An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.
  • Maximum Tolerated Dose (MTD) and Recommended phase 2 dose of MLN9708 (phase 1) [ Time Frame: Dose Limiting Toxcities determined in Cycle 1 to define MTD; MTD and adverse events monitored throughout the study will inform the recommended phase 2 dose, approximately 1 year ] [ Designated as safety issue: Yes ]
    Based on adverse events, serious adverse events, assessments of clinical laboratory values, neurotoxicity grading, and vital sign measurements
  • Number of patients with complete response and very partial response rate (phase 2) [ Time Frame: Patients will be assessed after each Cycle 1-4 and then every 2 cycles until disease progression, approximately 2 years ] [ Designated as safety issue: No ]
  • Number of grade 3 or higher adverse events, all serious adverse events, and treatment discontinuation (phase 2) [ Time Frame: From screening period through 30 days after the last dose of study drug or until the start of subsequent antineoplastic therapy, approximately 1 year and 30 days ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01383928 on ClinicalTrials.gov Archive Site
  • Phase 1: Cmax: Maximum Plasma Concentration for Ixazomib [ Time Frame: Cycle 1, Days 1 and 11 ] [ Designated as safety issue: No ]
    Maximum observed plasma concentration (Cmax) is the peak plasma concentration of ixazomib, obtained directly from the plasma concentration-time curve.
  • Phase 1: AUC(0-72): Area Under the Plasma Concentration-Time Curve From Time 0 to 72 Hours Postdose for Ixazomib [ Time Frame: Cycle 1, Days 1 and 11 ] [ Designated as safety issue: No ]
    AUC(0-72) is a measure of the area under the plasma concentration time-curve from time zero to 72 hours post-dose for ixazomib.
  • Phase 1: Tmax- Time to Reach the Maximum Plasma Concentration (Cmax) for Ixazomib [ Time Frame: Cycle 1, Days 1 and 11 ] [ Designated as safety issue: No ]
    Tmax: Time to reach the first maximum plasma concentration (Cmax), equal to time (hours) to Cmax of ixazomib after administration, obtained directly from the plasma concentration-time curve.
  • Phase 1: Rac: Accumulation Ratio of Ixazomib [ Time Frame: Cycle 1, Days 1 and 11 ] [ Designated as safety issue: No ]
    The accumulation ratio (Rac) was estimated as the ratio of AUC (0-72) on Day 11 to the AUC (0-72) on Day 1. AUC (0-72) is the area under the plasma concentration-time curve from time zero to 72 hours post-dose for ixazomib.
  • Phase 1: Percentage of Participants With Best Overall Response [ Time Frame: Baseline until end of study treatment (up to Cycle 35) ] [ Designated as safety issue: No ]
    Best response observed during study.CR:no immunofixation on serum,urine;soft tissue plasmacytomas disappearance;<5% plasma cells in bone marrow.Stringent CR(sCR):CR as defined,normal free light chain ratio,absence of clonal cells in bone marrow.Partial response(PR):>=50% reduction of serum M-protein,urinary M-protein by >=90%/to <200 mg/24 hr reduction.Near CR(nCR):positive immunofixation of serum/urine;soft tissue plasmacytomas disappearance;<=5% plasma cells in bone marrow.VGPR:serum,urine M-protein detectable by immunofixation but not on electrophoresis/>=90% reduction in serum M-protein+urine M-protein level <100 mg/24hr.Stable disease (SD):failure to attain CR,VGPR,PR/progressive disease (PD).PD:>=25% increase from lowest value in:serum/urine M-component;difference between involved,uninvolved FLC levels;bone marrow plasma cell percent;new bone lesions/soft tissue plasmacytomas development/existing bone lesions/soft tissue plasmacytomas size rise;hypercalcaemia development.
  • Phase 2: Percentage of Participants With Objective Response [ Time Frame: Baseline until end of study treatment (up to Cycle 35) ] [ Designated as safety issue: No ]
    Objective response is defined as CR, VGPR or PR based on IMWG Response Criteria for malignant lymphoma. CR: disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. VGPR: serum, urine M-protein detectable by immunofixation but not on electrophoresis or >=90% reduction in serum M-protein+urine M-protein level <100 mg/24h. Partial response (PR) is a minimum of 50% decrease in sum of the product of the diameters of up to 6 of the largest dominant nodes or nodal masses and no increase in the size of other nodes.
  • Phase 2: Percentage of Participants With Complete Response (CR) and Very Good Partial Response (VGPR) After Cycles 4, 8, and 16 [ Time Frame: Cycles 4, 8, and 16 ] [ Designated as safety issue: No ]
    CR as per IMWG criteria is defined as negative immunofixation on the serum and urine and disappearance of soft tissue plasmacytomas and <5% plasma cells in bone marrow. VGPR as per IMWG criteria is defined as serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100 mg per 24 hours. VGPR were applicable only to participants who had measurable disease defined by at least 1 of the following 3 measurements: Serum M-protein; Urine M-protein; Serum FLC assay.
  • Phase 2: Pecentage of Participants With Complete Response (CR) [ Time Frame: Baseline until end of study treatment (up to treatment cycle 35) ] [ Designated as safety issue: No ]
    CR as per IMWG criteria is negative immunofixation on serum and urine and disappearance of soft tissue plasmacytomas and <5% plasma cells in bone marrow.
  • Phase 2: Percentage of Participants With Stringent Complete Response (sCR) [ Time Frame: Baseline until end of study treatment (up to treatment cycle 35) ] [ Designated as safety issue: No ]
    sCR as per IMWG criteria is CR plus normal FLC ratio and absence of clonal cells in bone marrow. CR is negative immunofixation on serum and urine and disappearance of soft tissue plasmacytomas and <5% plasma cells in bone marrow.
  • Phase 2: Percentage of Participants With Very Good Partial Response (VGPR) [ Time Frame: Baseline until end of study treatment (up to treatment cycle 35) ] [ Designated as safety issue: No ]
    VGPR as per IMWG criteria is serum and urine M-protein detectable by immunofixation but not on electrophoresis or >=90% reduction in serum M-protein plus urine M-protein level <100 mg per 24 hours.
  • Phase 2: Percentage of Participants With Near Complete Response (nCR) [ Time Frame: Baseline until end of study treatment (up to treatment cycle 35) ] [ Designated as safety issue: No ]
    nCR as per IMWG criteria is positive immunofixation analysis of serum or urine as the only evidence of disease; appearance of any soft tissue plasmacytomas and <=5% plasma cells in bone marrow.
  • Phase 2: Percentage of Participants With Partial Response (PR) [ Time Frame: Baseline until end of study treatment (up to treatment cycle 35) ] [ Designated as safety issue: No ]
    PR as per IMWG criteria is 50% reduction of serum M-protein and reduction in 24-hr urinary M-protein by 90% or to <200 mg per 24 hours.
  • Phase 2: Percentage of Participants With Minimal Response (MR) [ Time Frame: Baseline until end of study treatment (up to treatment cycle 35) ] [ Designated as safety issue: No ]
    MR as per IMWG criteria is 25%-49% reduction in serum paraprotein and 50%-89% reduction in urine light chain excretion for 6 weeks.
  • Phase 2: Time to Response [ Time Frame: Baseline until end of study treatment (up to treatment cycle 35) ] [ Designated as safety issue: No ]
    Time to first response is defined as the time from the date of first dose of study treatment to the date of the first documentation of a confirmed response (PR or better) in a participant who responded + 1 day. PR as per IMWG criteria is 50% reduction of serum M-protein and reduction in 24-h urinary M-protein by 90% or to <200 mg per 24 hours.
  • Phase 2: Duration of Response (DOR) [ Time Frame: Baseline until end of study treatment (up to treatment cycle 35) ] [ Designated as safety issue: No ]
    DOR was measured as the time from the date of first documentation of a confirmed response to the date of first documented PD. PD is defined as >=25% increase from lowest value in: serum/urine M-component; difference between involved, uninvolved FLC levels; bone marrow plasma cell percent; development of new bone lesions or soft tissue plasmacytomas development or increase in the size of existing bone lesions or soft tissue plasmacytomas; hypercalcaemia development.
  • Phase 2: Time to Disease Progression (TTP) [ Time Frame: Baseline until progressive disease (up to treatment cycle 35) ] [ Designated as safety issue: No ]
    Time to progression was defined as the time from the date of first dose of study treatment to the date of first documentation of PD + 1 day. Participants that did not experience PD will be censored at the last response assessment that is SD or better. PD: >=25% increase from lowest value in:serum/urine M-component; difference between involved, uninvolved FLC levels; bone marrow plasma cell percent; new bone lesions/soft tissue plasmacytomas development/existing bone lesions/soft tissue plasmacytomas size rise; hypercalcaemia development. SD: not meeting criteria for CR, VGPR, PR, or PD. Participants that received Autologous Stem Cell Transplantation (ASCT) or an alternate cancer therapy were also be censored at the last response assessment that is, SD or better prior to initiation of therapy. Participants without response assessment will be censored at the date of first dose. TTP was analyzed using standard survival analysis techniques based on Kaplan-Meier estimates.
  • Phase 2: Progression Free Survival (PFS) [ Time Frame: Baseline until progressive disease (up to treatment cycle 35) ] [ Designated as safety issue: No ]
    PFS was defined as the time from the date of first dose of study treatment to the date of first documentation of progressive disease or to death due to any cause, whichever occurred first plus 1. PD: >=25% increase from lowest value in:serum/urine M-component; difference between involved,uninvolved FLC levels; bone marrow plasma cell percent; new bone lesions/soft tissue plasmacytomas development/existing bone lesions/soft tissue plasmacytomas size rise; hypercalcaemia development. SD: not meeting criteria for CR, VGPR, PR, or PD. Participants who received ASCT or an alternate anticancer therapy were censored at the last response assessment that was SD or better before initiation of therapy. Participants without a response assessment were censored at the date of first dose. PFS was analyzed using standard survival analysis techniques based on Kaplan-Meier estimates.
  • Phase 2: Percentage of Participants Achieving Survival at Year 1 [ Time Frame: 1 year after the first dose of study treatment ] [ Designated as safety issue: No ]
  • Phase 2: Overall Survival [ Time Frame: Baseline up to treatment cycle 35 ] [ Designated as safety issue: No ]
    Overall survival was measured as the time from the date of first dose of study treatment to the time of death plus 1 day. For participants who did not die, survival was censored at the date of last contact. Overall Survival was analyzed using standard survival analysis techniques based on Kaplan-Meier estimates.
  • Number of patients with response (phase 1) [ Time Frame: After each Cycle 1-4 and every two cycles thereafter; at end of treatment; and during progression-free survival follow-up (if applicable), expected duration approximately 2 years ] [ Designated as safety issue: No ]
  • Time to response (phase 2) [ Time Frame: From the first dose of study treatment to the date of first documentation of a confirmed response, approximately 1 year ] [ Designated as safety issue: No ]
  • Duration of response (phase 2) [ Time Frame: From the date of first documentation of a confirmed response to the date of progressive disease, approximately 1 year ] [ Designated as safety issue: No ]
  • Time to progression (phase 2) [ Time Frame: From the first dose of study treatment to the date of first documented progressive disease, approximately 3 years ] [ Designated as safety issue: No ]
  • Number of patients with progression free survival (phase 2) [ Time Frame: From the first dose of study treatment to the date of first documented progressive disease or death, approximately 3 years ] [ Designated as safety issue: No ]
  • Number of patients with overall survival (phase 2) [ Time Frame: From the first dose of study treatment to date of death, approximately 6 years ] [ Designated as safety issue: No ]
  • Maximum plasma concentration (Cmax), time to maximum plasma concentration (Tmax), and area under the plasma concentration-time curve (AUC) (phase 1) [ Time Frame: At multiple time points throughout Cycles 1-3, for approximately 43 days ] [ Designated as safety issue: No ]
  • Number of patients with overall response (phase 2) [ Time Frame: After Cycles 1-4 and every other cycle thereafter; at end of treatment; and during progression-free survival follow-up (if applicable), expected duration approximately 2 years ] [ Designated as safety issue: No ]
    Complete response + very good partial response + partial response
  • Number of patients with complete response + very good partial response (phase 2) [ Time Frame: After Cycles 4, 8, and 16, approximately 2 years ] [ Designated as safety issue: No ]
  • Number of patients with complete response, stringent complete response, very good partial response, near complete response, partial response, and minimal response (phase 2) [ Time Frame: After Cycles 1-4 and every other cycle thereafter; at end of treatment; and during progression-free survival follow-up (if applicable), expected duration approximately 2 years ] [ Designated as safety issue: No ]
  • Number of patients with 1-year survival (phase 2) [ Time Frame: 1 year after first dose of study treatment in the last patient treated ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study of Oral IXAZOMIB in Combination With Lenalidomide and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma
An Open-Label, Dose-Escalation, Phase 1/2 Study of the Oral Formulation of IXAZOMIB (MLN9708), Administered Twice-weekly in Combination With Lenalidomide and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Requiring Systemic Treatment

This will be a phase 1/2, multicenter, open-label study using the oral formulation of IXAZOMIB administered twice weekly in combination with lenalidomide and low-dose dexamethasone. Both phases of the study will include patients who have newly diagnosed multiple myeloma and have not previously received systemic treatment.

Both the phase 1 and the phase 2 portions of the study will include induction therapy consisting of 1 year of therapy followed by maintenance therapy that will continue until progressive disease or unacceptable toxicity. Maintenance therapy will be IXAZOMIB alone on Days 1,4,8, & 11 of a 21-day cycle.

Not Provided
Interventional
Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Myeloma
Drug: IXAZOMIB + Lenalidomide + Dexamethasone

Ph 1: Patients will receive escalating doses of IXAZOMIB orally on Days 1,4,8&11; plus dexamethasone orally on Days 1,2,4,5,8,9,11&12 at 20mg in Cycles 1-8/10mg in Cycles 9-16 & lenalidomide 25mg orally on Days 1-14 of a 21-day cycle. Treatment repeats every 21 days for up to 16 cycles in the absence of disease progression or unacceptable toxicity. Patients who have stable or responding disease will continue treatment in the maintenance therapy portion of the study.

Ph 2: Patients will receive IXAZOMIB orally at the maximum tolerated dose or recommended phase 2 dose on Days 1,4,8,11, plus dexamethasone orally on Days 1,2,4,5,8,9,11&12 at 20mg in Cycles 1-8/10mg in Cycles 9-16 and lenalidomide 25mg orally on Days 1-14 of a 21-day cycle. Treatment repeats every 21 days for up to 16 cycles in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease will continue treatment in the maintenance therapy portion of the study.

Experimental: IXAZOMIB + Lenalidomide + Dexamethasone
Intervention: Drug: IXAZOMIB + Lenalidomide + Dexamethasone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
April 2015
April 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female patients 18 years or older
  • Symptomatic multiple myeloma or asymptomatic myeloma with myeloma-related organ damage diagnosed according to standard criteria
  • Measurable disease as specified in study protocol
  • Hematologic, liver, and renal function as specified in the study protocol.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • Female patients who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception or agree to abstain from heterosexual intercourse; must also adhere to the guidelines of the lenalidomide pregnancy prevention program
  • Male patients who agree to practice effective barrier contraception or agree to abstain from heterosexual intercourse AND must adhere to the guidelines of the lenalidomide pregnancy prevention program
  • Must be able to take concurrent aspirin 325 mg daily
  • Voluntary written consent

Exclusion Criteria

  • Peripheral neuropathy that is greater or equal to Grade 2
  • Female patients who are lactating or pregnant
  • Major surgery or radiotherapy within 14 days before the first dose of study drug
  • Uncontrolled infection requiring systematic antibiotics within 14 days before the first dose of study drug
  • Diarrhea (> Grade 1)
  • Prior systemic therapy for multiple myeloma, including investigational drugs (prior treatment with corticosteroids or localized radiation therapy dose not disqualify the patient)
  • Systemic treatment with strong inhibitors of CYP1A2, strong inhibitors of CYP3A, or strong CYP3A inducers, or use of Ginkgo biloba or St. John's wort within 14 days before the first dose of study treatment
  • Central nervous system involvement
  • Diagnosis of smoldering multiple myeloma, Waldenstrom's macroglobulinemia, POEMS syndrome, plasma cell leukemia, primary amyloidosis, myelodysplastic syndrome, or myeloproliferative syndrome
  • Evidence of current uncontrolled cardiovascular conditions
  • Prior or concurrent deep vein thrombosis or pulmonary embolism
  • Known human immunodeficiency virus (HIV) positive, hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection
  • Serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to the protocol
  • Known allergy to any of the study medications
  • Known gastrointestinal condition or procedure that could interfere with swallowing or the oral absorption, or tolerance of IXAZOMIB
  • Diagnosed or treated for another malignancy within 2 years before the first dose or previously diagnosed with another malignancy and have any evidence of residual disease with the exception of nonmelanoma skin cancer or any completely resected carcinoma in situ
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01383928
C16008, U1111-1168-1172
No
Not Provided
Not Provided
Millennium Pharmaceuticals, Inc.
Millennium Pharmaceuticals, Inc.
Not Provided
Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.
Millennium Pharmaceuticals, Inc.
November 2015

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