Protocol No.UW21091
CC-220-MM-002
Principal InvestigatorSchmidt, Timothy
PhaseIII
Age GroupAdult
ClinicalTrials.GovNCT04975997 (Click to jump to clinicaltrials.gov)
Management Group(s) Myeloma

Title
A Phase 3, Randomized, Multicenter, Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Subjects with Relapsed or Refractory Multiple Myeloma (RRMM)

Description
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). Approximately 200 patients randomized in stage 1 to one of three iberdomide dose levels of 1, 1.3, or 1.6 mg in combination with daratumumab and dexamethasone (Treatment Arms A1, A2, or A3), or to the DVd comparator arm (Treatment Arm B).

In Stage 2 of the study, approximately 664 additional subjects will be randomized 1:1 between 2 treatment arms:



    Approximately 332 subjects will be randomized to receive Treatment Arm A (IberDd)

    Approximately 332 subjects will be randomized to receive Treatment Arm B (DVd)

Participants in both treatment arms will continue to receive treatment until confirmed progressive disease (PD), unacceptable toxicity or withdrawal of consent. To ensure accuracy and completeness of the primary endpoint assessment of progression-free survival (PFS), participants who permanently discontinue study treatment for any reason, other than confirmed PD or withdrawal of consent, will continue to be followed for disease assessment.

The study will be conducted in compliance with International Council for Harmonisation (ICH) and Good Clinical Practices (GCPs).

Objective
Primary Objective:
- To compare the efficacy of iberdomide, daratumumab and dexamethasone (IberDd) to that of daratumumab, bortezomib and dexamethasone (DVd) in terms of progression-free survival (PFS) in subjects with relapsed or refractory multiple myeloma (RRMM)

Secondary Objectives:
- To evaluate clinical efficacy in terms of overall survival (OS) in subjects with RRMM treated with IberDd compared to DVd
- To evaluate additional efficacy parameters in subjects with RRMM treated with IberDd compared to DVd
- To evaluate safety of IberDd compared to DVd in subjects with RRMM
- To evaluate cancer-related symptoms and health-related quality of life (HRQoL) using the European Organization for Research and Treatment of Cancer Quality of Life C30 questionnaire (EORTC QLQ-C30) and the European Quality of Life Multiple Myeloma Module (EORTC QLQ-MY20) in subjects with RRMM treated with IberDd compared to DVd

Treatment Experimental: Daratumumab in combination with Iberdomide and dexamethasone - Dose 1
Participants will receive oral iberdomide, subcutaneous daratumumab and oral dexamethasone.

Experimental: Daratumumab in combination with Iberdomide and dexamethasone - Dose 2

Experimental: Daratumumab in combination with Iberdomide and dexamethasone - Dose 3

Active Comparator: Daratumumab in combination with dexamethasone and bortezomib
Participants will receive subcutaneous daratumumab, bortezomib and oral dexamethasone

Key Eligibility Inclusion Criteria:



    Documented diagnosis of multiple myeloma (MM) and measurable disease

    Received 1 to 2 prior lines of anti-myeloma therapy

    Must have documented disease progression during or after their last anti-myeloma regimen

    Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2


Exclusion Criteria:


    Any condition that confounds the ability to interpret data from the study

    Has plasma cell leukemia, Waldenstrom's macroglobulinemia or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or clinically significant amyloidosis

    Known central nervous system involvement with MM

    Prior therapy with iberdomide

    Other protocol-defined inclusion/exclusion criteria apply

Applicable Disease Sites
Multiple Myeloma

Participating Institutions
UW Health University Hospital