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NCT01383928 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE1, PHASE2
Status at capture
COMPLETED
Registry last update
2019-03-21

The purpose of this study is to determine the safety, tolerability, maximum tolerated dose (MTD), and recommended phase 2 dose (RP2D) in phase 1 and to determine the combined response rate of clinical response CR and very good partial response (VGPR) in phase 2 of oral (PO) ixazomib administered twice-weekly in combination with lenalidomide and low-dose dexamethasone in a 21-day cycle in participants with newly diagnosed multiple myeloma (NDDM).

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Phase 1: Maximum Tolerated Dose (MTD)

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outcome · POSTED

Phase 1: Recommended Phase 2 Dose (RP2D)

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outcome · POSTED

Phase 1: Percentage of Participants Experiencing 1 or More Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs)

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outcome · POSTED

Phase 1: Number of Participants With Markedly Abnormal Laboratory Values Reported as Treatment Emergent Adverse Events (TEAEs)

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outcome · POSTED

Phase 1: Number of Participants With Treatment-Emergent Adverse Events (TEAE) Related to Neurotoxicity

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outcome · POSTED

Phase 1: Number of Participants With Clinically Significant Change From Baseline in Vital Signs

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outcome · POSTED

Phase 2: Percentage of Participants With Complete Response (CR) + Very Good Partial Response (VGPR)

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outcome · POSTED

Phase 2: Percentage of Participants With Grade 3 or Higher Adverse Events

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outcome · POSTED

Phase 2: Percentage of Participants Experiencing Serious Adverse Events

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outcome · POSTED

Phase 2: Percentage of Participants With Treatment-Emergent Adverse Events Resulting in Study Drug Discontinuation

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outcome · POSTED

Phase 1: Cmax: Maximum Plasma Concentration for Ixazomib

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outcome · POSTED

Phase 1: AUC(0-72): Area Under the Plasma Concentration-Time Curve From Time 0 to 72 Hours Postdose for Ixazomib

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outcome · POSTED

Phase 1: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Ixazomib

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outcome · POSTED

Phase 1: Rac: Accumulation Ratio of Ixazomib

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outcome · POSTED

Phase 1: Percentage of Participants With Best Overall Response

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outcome · POSTED

Phase 2: Percentage of Participants With Overall Response (CR+VGPR+PR)

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outcome · POSTED

Phase 2: Percentage of Participants With Complete Response (CR) and Very Good Partial Response (VGPR) After Cycles 4, 8, and 16

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outcome · POSTED

Phase 2: Percentage of Participants With Complete Response (CR)

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outcome · POSTED

Phase 2: Percentage of Participants With Stringent Complete Response (sCR)

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outcome · POSTED

Phase 2: Percentage of Participants With Very Good Partial Response (VGPR)

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outcome · POSTED

Phase 2: Percentage of Participants With Near Complete Response (nCR)

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outcome · POSTED

Phase 2: Percentage of Participants With Partial Response (PR)

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outcome · POSTED

Phase 2: Percentage of Participants With Minimal Response (MR)

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outcome · POSTED

Phase 2: Time to Response

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outcome · POSTED

Phase 2: Duration of Response (DOR)

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outcome · POSTED

Time to Disease Progression (TTP)

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outcome · POSTED

Progression Free Survival (PFS)

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outcome · POSTED

Kaplan-Meier Estimate of Percentage of Participants Achieving Survival at Year 1

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outcome · POSTED

Overall Survival

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
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
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Ixazomib (MLN9708), orally, twice-weekly in combination with lenalidomide orally and dexamethasone orally as prescribed, in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) orally, twice weekly in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
    intervention Names
    1. Drug: Ixazomib
    2. Drug: Lenalidomide
    3. Drug: Dexamethasone
    label
    Phase 1: Ixazomib 3 mg or 3.7 mg
    type
    EXPERIMENTAL
  2. description
    Ixazomib (MLN9708), orally, twice-weekly in combination with lenalidomide orally and dexamethasone orally as prescribed, in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) orally, twice weekly in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
    intervention Names
    1. Drug: Ixazomib
    2. Drug: Lenalidomide
    3. Drug: Dexamethasone
    label
    Phase 2: Ixazomib 3 mg
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Phase 1: Ixazomib 3 mg or 3.7 mg
    2. Phase 2: Ixazomib 3 mg
    description
    Ixazomib capsules
    name
    Ixazomib
    type
    DRUG
  2. arm Group Labels
    1. Phase 1: Ixazomib 3 mg or 3.7 mg
    2. Phase 2: Ixazomib 3 mg
    description
    Lenalidomide capsules
    name
    Lenalidomide
    type
    DRUG
  3. arm Group Labels
    1. Phase 1: Ixazomib 3 mg or 3.7 mg
    2. Phase 2: Ixazomib 3 mg
    description
    Dexamethasone Tablets
    name
    Dexamethasone
    type
    DRUG
Study design
allocation
NON_RANDOMIZED
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
64
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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.
    measure
    Phase 1: Maximum Tolerated Dose (MTD)
    time Frame
    Cycle 1 (21 days)
  2. description
    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. The maximum number of cycles received was 83 cycles (approximately up to 2037 days).
    measure
    Phase 1: Recommended Phase 2 Dose (RP2D)
    time Frame
    Cycle 1 (21 days)
  3. description
    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.
    measure
    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 (Up to Cycle 83 - approximately 2067 days)
  4. description
    Laboratory tests included chemistry, hematology and urinalysis. Abnormal laboratory value was assessed as an AE if the value lead to discontinuation or delay in treatment, dose modification, therapeutic intervention, or was considered by the investigator to be a clinically significant change from baseline. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
    measure
    Phase 1: Number of Participants With Markedly Abnormal Laboratory Values Reported as Treatment Emergent Adverse Events (TEAEs)
    time Frame
    Baseline up to 30 days after last dose of study drug (Up to Cycle 83 - approximately 2067 days)
  5. description
    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. Only TEAEs related to neurotoxicity with values are reported.
    measure
    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 (Up to Cycle 83 - approximately 2067 days)
  6. description
    Vital signs included body temperature, blood pressure and heart rate.
    measure
    Phase 1: Number of Participants With Clinically Significant Change From Baseline in Vital Signs
    time Frame
    Baseline up to 30 days after last dose of study drug (Up to Cycle 83 - approximately 2067 days)
  7. description
    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.
    measure
    Phase 2: Percentage of Participants With Complete Response (CR) + Very Good Partial Response (VGPR)
    time Frame
    Baseline until end of treatment (Up to treatment Cycle 74 - approximately 1875 days)
  8. description
    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.
    measure
    Phase 2: Percentage of Participants With Grade 3 or Higher Adverse Events
    time Frame
    Baseline up to 30 days after the last dose of study drug (approximately 1905 days)
  9. description
    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.
    measure
    Phase 2: Percentage of Participants Experiencing Serious Adverse Events
    time Frame
    Baseline up to 30 days after the last dose of study drug (approximately 1905 days)
  10. description
    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.
    measure
    Phase 2: Percentage of Participants With Treatment-Emergent Adverse Events Resulting in Study Drug Discontinuation
    time Frame
    Baseline up to 30 days after the last dose of study drug (approximately 1905 days)
secondary Outcomes
  1. description
    Maximum observed plasma concentration (Cmax) is the peak plasma concentration of ixazomib, obtained directly from the plasma concentration-time curve.
    measure
    Phase 1: Cmax: Maximum Plasma Concentration for Ixazomib
    time Frame
    Cycle 1, Days 1 and 11
  2. description
    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.
    measure
    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
  3. description
    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.
    measure
    Phase 1: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Ixazomib
    time Frame
    Cycle 1, Days 1 and 11
  4. description
    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.
    measure
    Phase 1: Rac: Accumulation Ratio of Ixazomib
    time Frame
    Cycle 1, Days 1 and 11
  5. description
    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. 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 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.
    measure
    Phase 1: Percentage of Participants With Best Overall Response
    time Frame
    Baseline until end of study treatment (Up to treatment Cycle 83 - approximately 2037 days)
  6. description
    Overall 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.
    measure
    Phase 2: Percentage of Participants With Overall Response (CR+VGPR+PR)
    time Frame
    Baseline until end of treatment (Up to treatment Cycle 74 - approximately 1875 days)
  7. description
    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.
    measure
    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
  8. description
    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.
    measure
    Phase 2: Percentage of Participants With Complete Response (CR)
    time Frame
    Baseline until end of treatment (Up to treatment Cycle 74 - approximately 1875 days)
  9. description
    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.
    measure
    Phase 2: Percentage of Participants With Stringent Complete Response (sCR)
    time Frame
    Baseline until end of treatment (Up to treatment Cycle 74 - approximately 1875 days)
  10. description
    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.
    measure
    Phase 2: Percentage of Participants With Very Good Partial Response (VGPR)
    time Frame
    Baseline until end of treatment (Up to treatment Cycle 74 - approximately 1875 days)
  11. description
    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.
    measure
    Phase 2: Percentage of Participants With Near Complete Response (nCR)
    time Frame
    Baseline until end of treatment (Up to treatment Cycle 74 - approximately 1875 days)
  12. description
    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.
    measure
    Phase 2: Percentage of Participants With Partial Response (PR)
    time Frame
    Baseline until end of treatment (Up to treatment Cycle 74 - approximately 1875 days)
Full study description
brief Summary
The purpose of this study is to determine the safety, tolerability, maximum tolerated dose (MTD), and recommended phase 2 dose (RP2D) in phase 1 and to determine the combined response rate of clinical response CR and very good partial response (VGPR) in phase 2 of oral (PO) ixazomib administered twice-weekly in combination with lenalidomide and low-dose dexamethasone in a 21-day cycle in participants with newly diagnosed multiple myeloma (NDDM).
detailed Description
The drug being tested in this study is called ixazomib. Ixazomib was tested to slow disease progression and improve overall survival in participants who have newly diagnosed multiple myeloma (NDMM). This study looked at the safety, tolerability and response in participants when administered in combination with lenalidomide and low-dose dexamethasone. The study enrolled 64 patients. Participants were assigned to one of the 3 treatment groups: * Phase 1 Ixazomib 3 mg * Phase 1 Ixazomib 3.7 mg * Phase 2 Ixazomib 3 mg All participants were administered with Ixazomib capsules, orally, twice-weekly on Days 1, 4, 8, and 11 along with lenalidomide capsules, orally, once daily on Days 1-14 and dexamethasone, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity. This multi-center trial conducted in the United States. The overall time to participate in this study was 2037 days. Participants will make multiple visits to the clinic, and a final visit after 30 days after last dose of study drug for a follow-up assessment.
Source references
Source notices and limitations
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