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Corticosteroid

Active Comparator: Ixazomib + LenDex for Multiple Myeloma

Phase 3
Waitlist Available
Research Sponsored by Millennium Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female participants 18 years or older diagnosed with Multiple Myeloma according to standard criteria who have not received prior treatment for multiple myeloma.
The participant is 65 years of age or older.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 9 years
Awards & highlights

Study Summary

This trial is testing a cancer treatment for people with newly diagnosed Multiple Myeloma who are not eligible for stem cell transplant.

Eligible Conditions
  • Multiple Myeloma

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 9 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 9 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression Free Survival (PFS)
Secondary outcome measures
Change From Baseline in HRQOL Measured by EORTC-QLQ-MY20 Scale
Change From Baseline in Health-Related Quality of Life (HRQOL) Measured by European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire (EORTC-QLQ)-C30 Scale Total Score
Cmax: Maximum Plasma Concentration for Ixazomib
+16 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Active Comparator: Ixazomib + LenDexActive Control3 Interventions
Participants who were randomly assigned to receive Ixazomib 4.0 mg capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) for the first 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).
Group II: Placebo + LenDexPlacebo Group3 Interventions
Participants who were randomly assigned to receive placebo matching capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) for the first 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib matching placebo capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).

Find a Location

Who is running the clinical trial?

Millennium Pharmaceuticals, Inc.Lead Sponsor
404 Previous Clinical Trials
46,244 Total Patients Enrolled
82 Trials studying Multiple Myeloma
9,357 Patients Enrolled for Multiple Myeloma
Medical Director Clinical ScienceStudy DirectorMillennium Pharmaceuticals, Inc.
196 Previous Clinical Trials
62,576 Total Patients Enrolled
8 Trials studying Multiple Myeloma
1,983 Patients Enrolled for Multiple Myeloma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~60 spots leftby Mar 2025