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NCT01217957 · REGISTRY CONDITION SEARCH

A Study of Ixazomib Administered in Combination With Lenalidomide and Low-Dose Dexamethasone in Patients 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
2018-03-14

The purpose of Phase 1 of this study was to determine the safety, tolerability, maximum tolerated dose (MTD), and recommended Phase 2 dose (RP2D) of oral ixazomib administered in combination with lenalidomide and low-dose dexamethasone in participants with newly diagnosed multiple myeloma (NDMM). The purpose of Phase 2 of this study was to determine the overall response rate (ORR) and further evaluate the tolerability and toxicity of the combination of oral ixazomib, lenalidomide, and low-dose dexamethasone in patients with NDMM.

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: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability

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outcome · POSTED

Phase 2: Objective Response Rate (ORR) Following Treatment With the Combination Of Oral Ixazomib, Lenalidomide And Low-Dose Dexamethasone

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outcome · POSTED

Phase 1: Recommended Phase 2 Dose of Ixazomib Given in Combination With Lenalidomide and Low-Dose Dexamethasone

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outcome · POSTED

Phase 1: Maximum Tolerated Dose (MTD) of Ixazomib Administered Weekly in Combination With Lenalidomide and Low-Dose Dexamethasone

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outcome · POSTED

Phase 2: Percentage of Participants With Grade 3 or Higher AEs, SAEs and Treatment Discontinuation

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outcome · POSTED

Phase 1: Cmax: Maximum Observed Plasma Concentration for Ixazomib

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outcome · POSTED

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

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outcome · POSTED

Phase 1: AUC(0-168): Area Under the Plasma Concentration-Time Curve From Time 0 to 168 Hours Postdose for Ixazomib

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outcome · POSTED

Phase 1: Rac: Accumulation Ratio of Ixazomib

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outcome · POSTED

Phase 1: Emax: Maximum Observed Inhibition of Whole Blood 20S Proteasome

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outcome · POSTED

Phase 1: TEmax: Time to the Maximum Observed Inhibition of Whole Blood 20S Proteasome

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outcome · POSTED

Phase 2: Time to Progression (TTP)

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outcome · POSTED

Phase 2: Overall Survival (OS)

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outcome · POSTED

Phase 2: Overall Response Rate (ORR)

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outcome · POSTED

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

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outcome · POSTED

Phase 2: Percentage of Participants With Complete Response (CR), Stringent Complete Response (sCR), Very Good Partial Response (VGPR), Near Complete Response (nCR), Partial Response (PR) and Minimal Response (MR)

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outcome · POSTED

Phase 2: Time to Best Response

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outcome · POSTED

Phase 2: Duration of Response (DOR)

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outcome · POSTED

Phase 2: Progression Free Survival (PFS)

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outcome · POSTED

Phase 2: 1 Year Survival Rate

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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: Each patient must meet all of the following eligibility criteria to be enrolled in the study: * Male or female patients 18 years or older * Previously untreated multiple myeloma diagnosed according to standard criteria requiring systemic treatment * Patients must have measurable disease * Nonsecretory multiple myeloma based upon standard M-component criteria (i.e., measurable serum/urine M-component) is not allowed unless the baseline serum free light chain level (Freelite™) is evaluated Patients must meet clinical laboratory criteria as specified in study protocol * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 * Female and male patients 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 Patients meeting any of the following exclusion criteria are not to be enrolled in the study: * 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 * Serious infection requiring systemic antibiotic therapy within 14 days before the first dose of study drug * Diarrhea greater than Grade 1 based on the National Cancer Institute Common Terminology Criteria for Adverse Events * Central nervous system involvement. * Evidence of current uncontrolled cardiovascular conditions within the past 6 months * 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 gastrointestinal condition that could interfere with swallowing or the oral absorption or tolerance of ixazomib * No other prior malignancy within 2 years except nonmelanoma skin cancer or carcinoma in situ of any type if they have undergone complete resection
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    In phase 1, ixazomib 1.68 mg/m\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68 mg/m\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
    intervention Names
    1. Drug: Ixazomib
    2. Drug: Lenalidomide
    3. Drug: Dexamethasone
    label
    Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone
    type
    EXPERIMENTAL
  2. description
    In phase 1, ixazomib 2.23 mg/m\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.23 mg/m\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
    intervention Names
    1. Drug: Ixazomib
    2. Drug: Lenalidomide
    3. Drug: Dexamethasone
    label
    Phase 1: Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone
    type
    EXPERIMENTAL
  3. description
    In phase 1, ixazomib 2.97 mg/m\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.97 mg/m\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
    intervention Names
    1. Drug: Ixazomib
    2. Drug: Lenalidomide
    3. Drug: Dexamethasone
    label
    Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone
    type
    EXPERIMENTAL
  4. description
    In phase 1, ixazomib 3.95 mg/m\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 3.95 mg/m\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
    intervention Names
    1. Drug: Ixazomib
    2. Drug: Lenalidomide
    3. Drug: Dexamethasone
    label
    Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone
    type
    EXPERIMENTAL
  5. description
    In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
    intervention Names
    1. Drug: Ixazomib
    2. Drug: Lenalidomide
    3. Drug: Dexamethasone
    label
    Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone
    2. Phase 1: Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone
    3. Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone
    4. Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone
    5. Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone
    description
    Ixazomib capsules
    name
    Ixazomib
    other Names
    1. MLN9708
    2. NINLARO®
    type
    DRUG
  2. arm Group Labels
    1. Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone
    2. Phase 1: Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone
    3. Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone
    4. Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone
    5. Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone
    description
    Lenalidomide capsules
    name
    Lenalidomide
    type
    DRUG
  3. arm Group Labels
    1. Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone
    2. Phase 1: Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone
    3. Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone
    4. Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone
    5. Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone
    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
65
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. 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 serious adverse event (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 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability
    time Frame
    Until occurrence of progressive disease or unacceptable toxicity (Up to 336 days)
  2. description
    ORR was defined as the percentage of participants with Complete (CR) + Very Good Partial Response (VGPR) assessed by the investigatory using International Myeloma Working Group (IMWG) Criteria. CR=Negative immunofixation on the serum and urine and; disappearance of any soft tissue plasmacytomas and; \< 5% plasma cells in bone marrow. VGPR=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.
    measure
    Phase 2: Objective Response Rate (ORR) Following Treatment With the Combination Of Oral Ixazomib, Lenalidomide And Low-Dose Dexamethasone
    time Frame
    Until occurrence of progressive disease or unacceptable toxicity (Up to 787 days)
  3. description
    RP2D will be determined based on number and type of adverse event and serious adverse events, assessments of clinical laboratory values, neurotoxicity grading, and treatment discontinuation.
    measure
    Phase 1: Recommended Phase 2 Dose of Ixazomib Given in Combination With Lenalidomide and Low-Dose Dexamethasone
    time Frame
    Until occurrence of progressive disease or unacceptable toxicity (Up to 336 days)
  4. description
    MTD of ixazomib will be determined by assessing adverse events and serious adverse events, clinical laboratory values, neurotoxicity grading, and vital sign measurements.
    measure
    Phase 1: Maximum Tolerated Dose (MTD) of Ixazomib Administered Weekly in Combination With Lenalidomide and Low-Dose Dexamethasone
    time Frame
    Until occurrence of progressive disease or unacceptable toxicity (Up to 336 days)
  5. 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 serious adverse event (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 With Grade 3 or Higher AEs, SAEs and Treatment Discontinuation
    time Frame
    Until occurrence of progressive disease or unacceptable toxicity (Up to 787 days)
secondary Outcomes
  1. description
    Cmax: 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 Observed Plasma Concentration for Ixazomib
    time Frame
    Cycle 1, Days 1 and 15
  2. description
    Tmax: Time to reach the first maximum observed plasma concentration (Cmax), equal to time (hours) to Cmax, obtained directly from the plasma concentration-time curve.
    measure
    Phase 1: Tmax: Time to Reach the Maximum Observed Plasma Concentration (Cmax) for Ixazomib
    time Frame
    Cycle 1, Days 1 and 15
  3. description
    AUC(0-168) is a measure of the area under the plasma concentration-time curve from time 0 to 168 hours postdose for Ixazomib.
    measure
    Phase 1: AUC(0-168): Area Under the Plasma Concentration-Time Curve From Time 0 to 168 Hours Postdose for Ixazomib
    time Frame
    Cycle 1, Days 1 and 15
  4. description
    The accumulation ratio (Rac) was estimated as the ratio of AUC(0-168) on Day 15 to the AUC(0-168) on Day 1. AUC(0-168) is the area under the plasma concentration-time curve from time 0 to 168 hours postdose for ixazomib.
    measure
    Phase 1: Rac: Accumulation Ratio of Ixazomib
    time Frame
    Cycle 1, Day 15
  5. description
    Emax is the maximum observed inhibition of whole blood 20S proteasome. The pharmacodynamics 20S Proteasome samples were collected and the assays were performed; however, concerns about the third-party laboratory's performance of the blood 20S proteasome activity assay were identified that precluded the ability to confirm the accuracy of the data so no data is reported.
    measure
    Phase 1: Emax: Maximum Observed Inhibition of Whole Blood 20S Proteasome
    time Frame
    Day 1 predose and at multiple time points (up to 168 hours) postdose and Day 15 predose and at multiple time points (up to 336 hours) postdose
  6. description
    TEmax is the time to the maximum observed inhibition of whole blood 20S proteasome. The pharmacodynamics 20S Proteasome samples were collected and the assays were performed; however, concerns about the third-party laboratory's performance of the blood 20S proteasome activity assay were identified that precluded the ability to confirm the accuracy of the data so no data is reported.
    measure
    Phase 1: TEmax: Time to the Maximum Observed Inhibition of Whole Blood 20S Proteasome
    time Frame
    Day 1 predose and at multiple time points (up to 168 hours) postdose and Day 15 predose and at multiple time points (up to 336 hours) postdose
  7. description
    TTP was measured as the time in months from the first dose of study treatment to the date of the first documented progressive disease (PD).
    measure
    Phase 2: Time to Progression (TTP)
    time Frame
    From the first dose of study treatment to the date of first documented progressive disease (Up to 787 days)
  8. description
    OS was measured as the time in months from the first dose of study treatment to the date of death + 1 day.
    measure
    Phase 2: Overall Survival (OS)
    time Frame
    From the first dose of study treatment to the date of death (up to 787 days)
  9. description
    ORR was defined as the percentage of participants with CR, VGPR and Partial Response (PR) assessed by the investigator using IMWG criteria. CR=Negative immunofixation on the serum and urine + Disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow. PR=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by 90% or to \< 200 mg per 24 hours. VGPR= 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.
    measure
    Phase 2: Overall Response Rate (ORR)
    time Frame
    Up to 787 days
  10. description
    Response was assessed by the investigator using International Myeloma Working Group (IMWG) Criteria. CR is defined as negative immunofixation on the serum and urine and; disappearance of any soft tissue plasmacytomas and; \< 5% plasma cells in bone marrow. VGPR 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.
    measure
    Phase 2: Percentage of Participants With Complete Response (CR) and Very Good Partial Response (VGPR)
    time Frame
    After Cycles 3, 6 and 9 (Up to 787 days)
  11. description
    Response was assessed by the investigator using International Myeloma Working Group (IMWG) Criteria. CR=Negative immunofixation on the serum and urine + Disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow. sCR= CR + Normal free light chain (FLC) ratio and Absence of clonal cells in bone marrow. PR=≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \< 200 mg per 24 hours. VGPR= 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. nCR=Positive immunofixation analysis of serum or urine as the only evidence of disease. Disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow. MR=25% to 49% reduction in serum paraprotein and 50% to 89% reduction in urine light chain excretion for 6 weeks.
    measure
    Phase 2: Percentage of Participants With Complete Response (CR), Stringent Complete Response (sCR), Very Good Partial Response (VGPR), Near Complete Response (nCR), Partial Response (PR) and Minimal Response (MR)
    time Frame
    Cycles 3, 6, 9 and 12 (Up to 787 days)
  12. description
    Time to Best Response was measured as the time in months from the first dose of study treatment to the date of first documented documentation of a confirmed response of partial response (PR) or better.
    measure
    Phase 2: Time to Best Response
    time Frame
    Up to 787 days
Full study description
brief Summary
The purpose of Phase 1 of this study was to determine the safety, tolerability, maximum tolerated dose (MTD), and recommended Phase 2 dose (RP2D) of oral ixazomib administered in combination with lenalidomide and low-dose dexamethasone in participants with newly diagnosed multiple myeloma (NDMM). The purpose of Phase 2 of this study was to determine the overall response rate (ORR) and further evaluate the tolerability and toxicity of the combination of oral ixazomib, lenalidomide, and low-dose dexamethasone in patients with NDMM.
detailed Description
The drug being tested in this study is called ixazomib. Ixazomib was being tested to treat people who had newly diagnosed multiple myeloma who had not previously received systemic treatment. This study was conducted in two Phases. Phase 1 looked at side effects and lab results in people who took ixazomib to determine the MTD and RP2D. Phase 2 looked at overall response rates and side effects in people who took ixazomib. The study enrolled 15 patients in Phase 1 and 50 patients in Phase 2. Participants in Phase 1 were assigned to cohorts and received ixazomib 1.68, 2.23, 2.97, or 3.95 mg/m\^2 in addition to dexamethasone 40 mg and lenalidomide 25 mg. Participants in Phase 2 received ixazomib 4.0 mg fixed dose in addition to dexamethasone 40 mg and lenalidomide 25 mg. In both Phases study treatment was administered in 28-day Cycles as follows: ixazomib Days 1, 8 and 15, dexamethasone Days 1, 8, 15 and 22, and lenalidomide 25 mg Days 1 through 21. This multi-center trial was conducted in the United States. The overall time to participate in this study was 12, 28-day cycles with the option to continue into a maintenance portion in the absence of disease progression or unacceptable toxicity. Participants made multiple visits to the clinic and a final visit 30 days after last dose of study drug for a follow-up assessment.
Source references
references
  1. citation
    Gupta N, Yang H, Hanley MJ, Zhang S, Liu R, Kumar S, Richardson PG, Skacel T, Venkatakrishnan K. Dose and Schedule Selection of the Oral Proteasome Inhibitor Ixazomib in Relapsed/Refractory Multiple Myeloma: Clinical and Model-Based Analyses. Target Oncol. 2017 Oct;12(5):643-654. doi: 10.1007/s11523-017-0524-3.
    pmid
    28803351
    type
    DERIVED
  2. citation
    Kumar SK, Berdeja JG, Niesvizky R, Lonial S, Laubach JP, Hamadani M, Stewart AK, Hari P, Roy V, Vescio R, Kaufman JL, Berg D, Liao E, Di Bacco A, Estevam J, Gupta N, Hui AM, Rajkumar V, Richardson PG. Safety and tolerability of ixazomib, an oral proteasome inhibitor, in combination with lenalidomide and dexamethasone in patients with previously untreated multiple myeloma: an open-label phase 1/2 study. Lancet Oncol. 2014 Dec;15(13):1503-1512. doi: 10.1016/S1470-2045(14)71125-8. Epub 2014 Nov 14.
    pmid
    25456369
    type
    DERIVED
Source notices and limitations
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