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Trial record 1 of 1 for:    c16029
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An Efficacy Study Comparing Oral Ixazomib/Dexamethasone and Oral Pomalidomide/Dexamethasone in Relapsed and/or Refractory Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03170882
Recruitment Status : Active, not recruiting
First Posted : May 31, 2017
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
Takeda ( Millennium Pharmaceuticals, Inc. )

Tracking Information
First Submitted Date  ICMJE May 22, 2017
First Posted Date  ICMJE May 31, 2017
Last Update Posted Date November 13, 2019
Actual Study Start Date  ICMJE August 1, 2017
Estimated Primary Completion Date September 17, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 11, 2019)
Progression Free Survival (PFS) [ Time Frame: From date of randomization until first occurrence of confirmed disease progression or death due to any cause, whichever occurs first (Up to 4 years) ]
PFS: Time from randomization to first occurrence of confirmed progressive disease (PD) as assessed by investigator by International Myeloma Working Group(IMWG) response criteria/death from any cause, whichever occurs first. PD requires following: Increase of greater than or equal to (>=) 25percent (%) from nadir in: Serum M component (increase must be >=0.5 gram per deciliter [g/dl]); Urine M-component (increase must be >=200 milligram [mg]/24-hour); In participants without measurable serum and urine M-protein levels difference between involved and uninvolved free light chain (FLC) increase of greater than (>) 10 mg/dl; In participants without measurable serum and urine M protein levels and without measurable disease by FLC level: bone marrow plasma cell percentage must be >=10%; Development of new/increase in size of existing bone lesions/soft tissue plasmacytomas; development of hypercalcemia(>11.5mg/dL corrected serum calcium)attributed solely to plasma cell proliferative disease.
Original Primary Outcome Measures  ICMJE
 (submitted: May 26, 2017)
Progression Free Survival (PFS) [ Time Frame: From date of randomization until disease progression or death due to any cause, whichever occurs first (Up to 7 years) ]
PFS is defined as time from randomization to first documentation of progressive disease (PD) based on central laboratory results and assessment by an independent review committee (IRC) using modified International Myeloma Working Group (IMWG) response criteria or death due to any cause, whichever occurs first. PD requires following:Increase of ≥25% from nadir in:Serum M-component (increase must be ≥0.5 g/dl);Urine M-component (increase must be ≥200 mg/24-hour);In participants without measurable serum and urine M-protein levels difference between involved and uninvolved free light chain (FLC) levels increase of >10 mg/dl;In participants without measurable serum and urine M protein levels and without measurable disease by FLC level:bone marrow plasma cell percentage must be ≥10%;Development of new/ increase in size of existing bone lesions/ soft tissue plasmacytomas;development of hypercalcemia (>11.5 mg/dL corrected serum calcium) attributed solely to plasma cell proliferative disease.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 11, 2019)
  • Overall Survival (OS) [ Time Frame: From randomization to death from any cause (Up to 4 years) ]
    OS is defined as the time from randomization to death from any cause.
  • Percentage of Participants with Objective Response Rate (ORR - Partial Response [PR], Very Good Partial Response [VGPR] and Complete Response [CR]) [ Time Frame: Day 1 of Cycle 1 (28 day cycle) then every cycle until disease progression for up to 4 years ]
    ORR is based on laboratory results and IRC assessment using modified IMWG criteria. PR: >=50% reduction of serum M protein + reduction in 24-hour urinary M protein by >=90% or to <200 mg/24-hour; if M protein is not measurable, >=50% decrease in difference between involved and uninvolved FLC levels is required; if not measurable by FLC, >=50% reduction in bone marrow plasma cells, when baseline value >=30% and; if present at baseline, >=50% reduction in size of soft tissue plasmacytomas is required; VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis or >=90% reduction in serum M-protein + urine M-protein level <100 mg/24-hour. CR: negative immunofixation on serum + urine; disappearance of soft tissue plasmacytomas; less than (<)5% plasma cells in bone marrow.
  • Duration of Response (DOR) [ Time Frame: Day 1 of Cycle 1 (28 day cycle) then every cycle until disease progression for up to 4 years ]
    DOR: Time from first documentation of CR/PR/VGPR to first documentation of PD. Per IMWG criteria, PR:>=50% reduction of serum M protein+reduction in 24-hour urinary M protein by >=90% to <200 mg/24-hour or >=50% decrease in difference between involved and uninvolved FLC levels/ >=50% reduction in bone marrow plasma cells, if >=30% at baseline/ >=50% reduction in size of soft tissue plasmacytomas. VGPR: serum+urine M-protein detectable by immunofixation but not on electrophoresis/ >=90% reduction in serum M-protein + urine M-protein level <100 mg/24-hour. CR:negative immunofixation on serum + urine+disappearance of soft tissue plasmacytomas+<5% plasma cells in bone marrow. PD:serum M-component increase >=0.5 g/dl or urine M-component increase >=200 mg/24-hour/ difference between involved and uninvolved FLC levels increase >10 mg/dl or bone marrow plasma cell >=10%/development of new/ increase in size of existing bone lesions or soft tissue plasmacytoma or development of hypercalcemia.
  • Time to Response [ Time Frame: Day 1 of Cycle 1 (28 day cycle) then every cycle until the first documentation of PR or PR/VGPR/CR for up to 4 years ]
    Time to response is defined as the time from randomization to the first documentation of PR/VGPR/CR. Per IMWG criteria PR is defined as >=50% reduction of serum M protein + reduction in 24-hour urinary M protein by >=90% or to <200 mg/24-hour; if M-protein is not measurable, >=50% decrease in difference between involved and uninvolved FLC levels is required; if not measurable by FLC, >=50% reduction in bone marrow plasma cells, when baseline value >=30% and; if present at baseline, >=50% reduction in size of soft tissue plasmacytomas is required; VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis or >=90% reduction in serum M-protein + urine M-protein level <100 mg/24-hour. CR: negative immunofixation on serum + urine; disappearance of soft tissue plasmacytomas; <5% plasma cells in bone marrow.
  • Time to Progression (TTP) [ Time Frame: Day 1 of Cycle 1 (28 day cycle) then every cycle until disease progression for up to 4 years ]
    TTP is defined as the time from randomization to first documentation of PD. Per IMWG criteria, PD requires 1 of the following: Increase of >=25% from nadir in: Serum M-component (increase must be >=0.5 g/dl; Urine M-component (increase must be >=200 mg/24-hour); In participants without measurable serum and urine M-protein levels difference between involved and uninvolved FLC levels increase of >10 mg/dl; In participants without measurable serum and urine M protein levels and without measurable disease by FLC level: Bone marrow plasma cell percentage must be >=10%; Development of new or increase in size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (>11.5 mg/dL corrected serum calcium) attributed solely to plasma cell proliferative disease.
  • Health-Related Quality of Life (HRQOL) based on European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire- Core 30 (EORTC QLQ-C30) Physical Domain Score [ Time Frame: Baseline up to 4 years ]
    The EORTC QLQ-C30 physical domain consists of 5 items covering participant's daily physical activities. The total score reported is between 0 and 100, with a high score indicating better functioning.
  • HRQOL based on EORTC QLQ-C30 Total Score [ Time Frame: Baseline up to 4 years ]
    The EORTC QLQ-C30 contains 30 items across 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial difficulties) and a global health status/quality of life (QOL) scale. Most of the 30 items have 4 response levels (not at all, a little, quite a bit, and very much), with 2 questions relying on a 7-point numeric rating scale. Raw scores are converted into scale scores ranging from 0 to 100. For the functional scales and the global health status/QOL scale, higher scores represent better QOL; for the symptom scales, lower scores represent better QOL.
  • HRQOL based on EORTC Multiple Myeloma Module (EORTC QLQ-MY20) Score [ Time Frame: Baseline up to 4 years ]
    The EORTC QLQ-MY20 has 20 items across 4 independent subscales, 2 functional subscales (body image, future perspective), and 2 symptoms scales (disease symptoms, and side effects of treatment). Scores are averaged, and transformed to 0-100 scale. For the future perspective scale, higher score is equal to (=) better perspective of the future. For the body image scale, higher scores = better body image. Higher score for the disease symptoms scale = higher level of symptomatology.
  • HRQOL based on 5-level Classification System of the EuroQol 5-Dimensional Health Questionnaire (EQ-5D-5L) Score [ Time Frame: Baseline up to 4 years ]
    The EQ-5D-5L consists of 2 domains: the EQ-5D-5L descriptive system and the EuroQol visual analogue scale (EQ VAS). The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each rated on 5 levels. 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, 5= extremely severe problems. The EQ VAS records the respondent's self-rated health on a 20 centimeter (cm), vertical, visual analogue scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). The scores from all dimensions are combined into a single index score that is reported.
  • Health Care Utilization (HU): Number of Medical Encounters [ Time Frame: Baseline up to 4 years ]
    HU as measured by the number of medical encounters.
  • HU: Duration of Medical Encounters [ Time Frame: Baseline up to 4 years ]
    HU as measured by the duration of medical encounters.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 26, 2017)
  • Overall Survival (OS) [ Time Frame: From randomization up to 10 years ]
    OS is defined as the time from randomization to death from any cause.
  • Percentage of Participants with Objective Response Rate (ORR - Partial Response [PR], Very Good Partial Response [VGPR] and Complete Response [CR]) [ Time Frame: Day 1 of Cycle 1 (28 day cycle) then every cycle until disease progression for up to 7 years ]
    ORR is based on laboratory results and independent review committee (IRC) assessment using modified IMWG criteria. PR: ≥50% reduction of serum M protein + reduction in 24-hour urinary M protein by ≥90% or to <200 mg/24-hour; if M protein is not measurable, ≥50% decrease in difference between involved and uninvolved FLC levels is required; if not measurable by FLC, ≥50% reduction in bone marrow plasma cells, when baseline value = ≥30% and; if present at baseline, ≥50% reduction in size of soft tissue plasmacytomas is required; VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein + urine M-protein level <100 mg/24-hour. CR: negative immunofixation on serum + urine; disappearance of soft tissue plasmacytomas; <5% plasma cells in bone marrow.
  • Duration of Response (DOR) [ Time Frame: Day 1 of Cycle 1 (28 day cycle) then every cycle until disease progression for up to 7 years ]
    DOR is defined as time from first documentation of CR/PR/VGPR to first documentation of PD. Per IMWG criteria, PR:≥50% reduction of serum M protein+reduction in 24-hour urinary M protein by ≥90%/ to <200 mg/24-hour or ≥50% decrease in difference between involved and uninvolved FLC levels/ ≥50% reduction in bone marrow plasma cells, if ≥30% at baseline/ ≥50% reduction in size of soft tissue plasmacytomas. VGPR:serum+urine M-protein detectable by immunofixation but not on electrophoresis/ ≥90% reduction in serum M-protein+urine M-protein level <100 mg/24-hour. CR:negative immunofixation on serum+urine+disappearance of soft tissue plasmacytomas+<5% plasma cells in bone marrow. PD:serum M-component increase ≥0.5 g/dl or urine M-component increase ≥200 mg/24-hour/ difference between involved and uninvolved FLC levels increase >10 mg/dl or bone marrow plasma cell ≥10%/ development of new/ increase in size of existing bone lesions or soft tissue plasmacytoma or development of hypercalcemia.
  • Time to Response [ Time Frame: Day 1 of Cycle 1 (28 day cycle) then every cycle until the first documentation of PR or PR/VGPR/CR for up to 7 years ]
    Time to response is defined as the time from randomization to the first documentation of PR/VGPR/CR. Per IMWG criteria PR is defined as ≥50% reduction of serum M protein + reduction in 24-hour urinary M protein by ≥90% or to <200 mg/24-hour; if M-protein is not measurable, ≥50% decrease in difference between involved and uninvolved FLC levels is required; if not measurable by FLC, ≥50% reduction in bone marrow plasma cells, when baseline value = ≥30% and; if present at baseline, ≥50% reduction in size of soft tissue plasmacytomas is required; VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein + urine M-protein level <100 mg/24-hour. CR: negative immunofixation on serum + urine; disappearance of soft tissue plasmacytomas; <5% plasma cells in bone marrow.
  • Time to Progression (TTP) [ Time Frame: Day 1 of Cycle 1 (28 day cycle) then every cycle until disease progression for up to 7 years ]
    TTP is defined as the time from randomization to first documentation of PD. Per IMWG criteria, PD requires 1 of the following: Increase of ≥25% from nadir in: Serum M-component (increase must be ≥0.5 g/dl; Urine M-component (increase must be ≥200 mg/24-hour); In participants without measurable serum and urine M-protein levels difference between involved and uninvolved FLC levels increase of >10 mg/dl; In participants without measurable serum and urine M protein levels and without measurable disease by FLC level: Bone marrow plasma cell percentage must be ≥10%; Development of new or increase in size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (>11.5 mg/dL corrected serum calcium) attributed solely to plasma cell proliferative disease.
  • Health-Related Quality of Life (HRQOL) based on European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire- Core 30 (EORTC QLQ-C30) Physical Domain Score [ Time Frame: Baseline up to 7 years ]
    The EORTC QLQ-C30 physical domain consists of 5 items covering participant's daily physical activities. The total score reported is between 0 and 100, with a high score indicating better functioning.
  • HRQOL based on EORTC QLQ-C30 Total Score [ Time Frame: Baseline up to 7 years ]
    The EORTC QLQ-C30 contains 30 items across 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial difficulties) and a global health status/QOL scale. Most of the 30 items have 4 response levels (not at all, a little, quite a bit, and very much), with 2 questions relying on a 7-point numeric rating scale. Raw scores are converted into scale scores ranging from 0 to 100. For the functional scales and the global health status/QOL scale, higher scores represent better QOL; for the symptom scales, lower scores represent better QOL.
  • HRQOL based on EORTC Multiple Myeloma Module (EORTC QLQ-MY20) Score [ Time Frame: Baseline up to 7 years ]
    The EORTC QLQ-MY20 has 20 items across 4 independent subscales, 2 functional subscales (body image, future perspective), and 2 symptoms scales (disease symptoms, and side effects of treatment). Scores are averaged, and transformed to 0-100 scale. For the future perspective scale, higher score = better perspective of the future. For the body image scale, higher scores = better body image. Higher score for the disease symptoms scale = higher level of symptomatology.
  • HRQOL based on 5-level Classification System of the EuroQol 5-Dimensional Health Questionnaire (EQ-5D-5L) Score [ Time Frame: Baseline up to 7 years ]
    The EQ-5D-5L consists of 2 domains: the EQ-5D-5L descriptive system and the EuroQol visual analogue scale (EQ VAS). The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each rated on 5 levels. 1 = no problems, 2 = slight problems, 3= moderate problems, 4= severe problems, 5 = extremely severe problems. The EQ VAS records the respondent's self-rated health on a 20 cm, vertical, visual analogue scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). The scores from all dimensions are combined into a single index score that is reported.
  • Health Care Utilization (HU): Number of Medical Encounters [ Time Frame: Baseline up to 7 years ]
    HU as measured by the number of medical encounters.
  • HU: Duration of Medical Encounters [ Time Frame: Baseline up to 7 years ]
    HU as measured by the duration of medical encounters.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Efficacy Study Comparing Oral Ixazomib/Dexamethasone and Oral Pomalidomide/Dexamethasone in Relapsed and/or Refractory Multiple Myeloma
Official Title  ICMJE A Phase 2, Randomized, Open-Label Study Comparing Oral Ixazomib/Dexamethasone and Oral Pomalidomide/Dexamethasone in Relapsed and/or Refractory Multiple Myeloma
Brief Summary The purpose of this study is to compare the effect of ixazomib + dexamethasone (ixa + dex) versus pomalidomide + dexamethasone (pom + dex) on progression-free survival (PFS) in participants with relapsed and/or refractory multiple myeloma (RRMM) who have received at least 2 prior lines of therapy, including lenalidomide and a proteasome inhibitor, and are refractory to lenalidomide but not refractory to proteasome inhibitors.
Detailed Description

The drug being tested in this study is called Ixazomib. Ixazomib is being tested to treat people who have RRMM. This study will compare the efficacy and safety in participants who take ixazomib and dexamethasone to pomalidomide and dexamethasone. It is an open-label, Phase 2 study.

The study will enroll approximately 120 participants. Participants will receive:

  • Ixazomib 4 mg + dexamethasone 20 mg (or 10 mg if participant is aged >=75 years) OR
  • pomalidomide 4 mg + dexamethasone 40 mg (or 20 mg if participant is aged >=75 years)

All participants will be asked to take either ixazomib plus dexamethasone (in cases where only 4 mg tablets for dexamethasone are available, the following dexamethasone schedule is recommended for participants aged >=75 years: 12 mg dexamethasone will be given on Days 1, 8, 15, and 22 of every 28-day cycle; and 8 mg dexamethasone will be given on Days 2, 9, 16, and 23 of every 28-day cycle) or pomalidomide 4 mg + dexamethasone 40 mg at recommended doses.

This multi-center trial will be conducted worldwide. The overall time to participate in this study is approximately 28 months after the first participant enters the study.

Participants will make multiple visits to the clinic, and will be contacted for PFS follow-up, in case of study drug discontinuation for up to 4 years from first dose administration. After disease progression, participants will be followed-up for OS every 12 weeks until death or up to 4 years.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Relapsed and/or Refractory Multiple Myeloma
Intervention  ICMJE
  • Drug: Ixazomib
    Ixazomib capsules.
    Other Names:
    • NINLARO
    • MLN9708
  • Drug: Pomalidomide
    Pomalidomide capsules.
  • Drug: Dexamethasone
    Dexamethasone tablets.
Study Arms  ICMJE
  • Experimental: Ixazomib plus dexamethasone
    Ixazomib 4 mg as starting dose, capsules, orally on Days 1, 8, and 15 of each 28-day cycle, with escalation to 5.5 mg at Cycle 2 for participants who tolerate the 4 mg dose in Cycle 1, plus dexamethasone 20 mg (or 10 mg if participant is aged >=75 years) tablets, orally, on Days 1, 2, 8, 9, 15, 16, 22, and 23 of every 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study (up to 28 months).
    Interventions:
    • Drug: Ixazomib
    • Drug: Dexamethasone
  • Active Comparator: Pomalidomide plus dexamethasone
    Pomalidomide 4 mg, capsules, orally on Days 1 to 21 of each 28-day cycle plus dexamethasone 40 mg, (or 20 mg if participant is aged >=75 years), tablets, orally on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study (up to 28 months).
    Interventions:
    • Drug: Pomalidomide
    • Drug: Dexamethasone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 11, 2019)
120
Original Estimated Enrollment  ICMJE
 (submitted: May 26, 2017)
300
Estimated Study Completion Date  ICMJE December 11, 2020
Estimated Primary Completion Date September 17, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Must have a confirmed diagnosis of multiple myeloma (MM) requiring therapy according to IMWG criteria.
  2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
  3. Must have had a relapse or PD after having received 2 or more prior lines of systemic therapy. Note: A line of therapy is defined as 1 or more cycles of a planned treatment program; this may consist of 1 or more planned cycles of single-agent therapy or combination therapy, as well as a sequence of treatments administered in a planned manner. For example, a planned treatment approach of induction therapy followed by autologous SCT, followed by maintenance is considered 1 line of therapy. Typically each line of therapy is separated by PD. Discussion with the medical monitor may help clarify the number of lines of therapy that a prospective study participant had.
  4. Must be refractory to lenalidomide, defined as having received at least 2 consecutive cycles of lenalidomide as a single agent or within a lenalidomide-containing regimen and having had PD during treatment with or within 60 days after the last dose of lenalidomide. The starting dose of lenalidomide should have been 25 mg (or as low as 10 mg in the case of renal function impairment or other safety concern), and the final dose should have been a minimum of 10 mg.
  5. Must have received at least 2 consecutive cycles of a bortezomib- or carfilzomib-containing regimen, and either:

    Achieved at least a PR and did not have PD during treatment with or within 60 days after the last dose of bortezomib or carfilzomib, OR

    o Had bortezomib and/or carfilzomib intolerance (defined as discontinuation because of drug-related adverse events [AEs] before completion of the planned treatment course) without PD before the start of the next regimen.

  6. Must have measurable disease defined by:

    • Serum M-protein >=1 g/dL (>=10 g/L), OR
    • Urine M-protein >=200 mg/24 hours and must have documented MM isotype by immunofixation (central laboratory).
  7. Suitable venous access for the study-required blood sampling, including pharmacokinetic (PK) sampling.
  8. Recovered (that is, less than or equal to [<=] Grade 1 nonhematologic toxicity) from the reversible effects of prior anticancer therapy.
  9. Must be willing and able to adhere to pomalidomide-related risk mitigation activities if randomized to the pom+dex arm (example, Risk Evaluation and Mitigation Strategies [REMS], pregnancy prevention programs).

Exclusion Criteria:

  1. Prior allogenic bone marrow transplantation in any prior line of therapy or prior autologous SCT in the last prior line of therapy- unless the autologous SCT was performed a year or more before disease progression.
  2. Diagnosed with or treated for another malignancy within 2 years before randomization, or previously diagnosed with another malignancy and have any evidence of residual, persistent, or recurrent disease. Participants with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
  3. Diagnosis of smoldering MM, Waldenström's macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes) syndrome, plasma cell leukemia, primary amyloidosis, myelodysplastic syndrome, or myeloproliferative syndrome.
  4. Peripheral neuropathy Grade 1 with pain or Grade 2 or higher peripheral neuropathy of any cause on clinical examination during the Screening period.
  5. Treatment with any investigational products or with chimeric or fully human monoclonal antibodies within 30 days before randomization, systemic anticancer therapy or radiotherapy within 14 days before randomization (Note: "spot" radiation for areas of pain is permitted), and major surgery within 14 days before randomization.
  6. Known gastrointestinal disease or gastrointestinal procedure that could interfere with the oral absorption or tolerance of study therapy, including difficulty swallowing.
  7. Serious infection requiring parenteral antibiotic therapy or any other serious infection within 14 days before randomization.
  8. Central nervous system involvement with MM (by clinical symptoms and signs).
  9. Ongoing or active systemic infection, known human immunodeficiency virus-ribonucleic acid (RNA) positive, known hepatitis B surface antigen seropositive, or known hepatitis C virus-RNA positive.
  10. Systemic treatment with strong cytochrome P-450 3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital) or use of St. John's wort within 14 days before randomization.
  11. Admission or evidence of illicit drug use, drug abuse, or alcohol abuse.
  12. History of severe cutaneous reactions, including hypersensitivity reactions such as Stevens-Johnson syndrome (SJS), Toxic Epidermal Necrolysis (TEN), and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), in the context of treatment with lenalidomide or thalidomide.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Canada,   Czechia,   Denmark,   France,   Germany,   Greece,   Israel,   Italy,   Netherlands,   Norway,   Russian Federation,   Spain,   Sweden,   Turkey,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03170882
Other Study ID Numbers  ICMJE C16029
2016-004742-28 ( EudraCT Number )
U1111-1188-2677 ( Other Identifier: WHO )
2017/1235 ( Registry Identifier: Norwegian Medicines Agency )
N-20170083 ( Registry Identifier: Danish Medicines Agency )
17/NW/0546 ( Registry Identifier: NRES )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
Responsible Party Takeda ( Millennium Pharmaceuticals, Inc. )
Study Sponsor  ICMJE Millennium Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Clinical Science Millennium Pharmaceuticals, Inc.
PRS Account Takeda
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP