Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)

Summary

This is a multicenter, two-stage, randomized, controlled, open-label, Phase 3 study comparing the efficacy and safety of iberdomide in combination with dexamethasone and daratumumab (IberDd) versus daratumumab, bortezomib, and dexamethasone (DVd) in participants with relapsed or refractory multiple myeloma (RRMM).

Conditions

• Multiple Myeloma

Interventions

DRUG

Dexamethasone

Oral dexamethasone 40mg on days 1, 8, 15, 22 of a 28-day cycle

DRUG

Daratumumab

Subcutaneous Daratumumab 1800mg on Days 1, 8, 15 and 22 for Cycles 1 to 2, on Days 1 and 15 for Cycles 3 to 6, and then on Day 1 for Cycle 7+ of a 28-day cycle

DRUG

Bortezomib

Subcutaneous Bortezomib 1.3 mg/m2 on Days 1, 4, 8 and 11 of each 21-day cycle for a total of 8 cycles.

DRUG

Iberdomide

Oral Iberdomide 1.0mg on Days 1 to 21 of a 28-day cycle

DRUG

Iberdomide

Oral Iberdomide 1.3mg on Days 1 to 21 of a 28-day cycle

DRUG

Iberdomide

Oral Iberdomide 1.6mg on Days 1 to 21 of a 28-day cycle

DRUG

Dexamethasone

Oral dexamethasone 20mg on days 1,2, 4,5,8,9,11,12 of a 21-day cycle from cycles 1-8

DRUG

Daratumumab

Subcutaneous daratumumab 1800mg Cycles 1 to 3 on Days 1, 8, 15 of a 21-day cycle, Cycles 4 to 8 on Day 1 of a 21-day cycle and Cycles 9+ on Day 1 of a 28-day cycle.

Sponsors & Collaborators

• Celgene

  lead INDUSTRY

Principal Investigators

• Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-06-23

Primary Completion

2027-11-16

Completion

2032-06-25

FDA Drug

Yes

Countries

• United States
• Argentina
• Australia
• Austria
• Belgium
• Brazil
• Canada
• China
• Czechia
• Denmark
• Finland
• France
• Germany
• Greece
• India
• Ireland
• Israel
• Italy
• Japan
• Mexico
• Netherlands
• Norway
• Poland
• Portugal
• South Korea
• Spain
• Sweden
• Switzerland
• Taiwan
• Turkey (Türkiye)
• United Kingdom

Study Locations