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

PHASE3RECRUITING

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).

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Study details:

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).

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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.

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2022-06-23

Primary completion: 2026-03-18

Study completion finish: 2032-06-25

Study type

TREATMENT

Phase

PHASE3

Trial ID

NCT04975997

Intervention or treatment

DRUG: Dexamethasone

DRUG: Daratumumab

DRUG: Bortezomib

DRUG: Iberdomide

Conditions

• Multiple Myeloma

Condition: Multiple Myeloma
DRUG: Dexamethasone and other drugs
Birtinya, Queensland, Australia and more
Sponsor: Celgene

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Sunshine Coast University Hospital

Research sites nearby

Select from list below to view details:

Sunshine Coast University Hospital
Birtinya, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Monash Medical Centre
Clayton, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Daratumumab in combination with Iberdomide and dexamethasone - Dose 1 Participants will receive oral iberdomide, subcutaneous daratumumab and oral dexamethasone.	DRUG: Dexamethasone Oral dexamethasone 40mg on days 1, 8, 15, 22 of a 28-day cycle
EXPERIMENTAL: Daratumumab in combination with Iberdomide and dexamethasone - Dose 2 Not Specified	DRUG: Dexamethasone Oral dexamethasone 40mg on days 1, 8, 15, 22 of a 28-day cycle
EXPERIMENTAL: Daratumumab in combination with Iberdomide and dexamethasone - Dose 3 Not Specified	DRUG: Dexamethasone Oral dexamethasone 40mg on days 1, 8, 15, 22 of a 28-day cycle
ACTIVE_COMPARATOR: Daratumumab in combination with dexamethasone and bortezomib Participants will receive subcutaneous daratumumab, bortezomib and oral dexamethasone	DRUG: Dexamethasone Oral dexamethasone 40mg on days 1, 8, 15, 22 of a 28-day cycle

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Progression-free Survival (PFS)	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 participants with relapsed or refractory multiple myeloma (RRMM).	Up to approximately 5 years

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Overall Survival (OS)	To evaluate clinical efficacy in terms of overall survival (OS) in participants with relapsed or refractory multiple myeloma (RRMM) treated with iberdomide, daratumumab, and dexamethasone (IberDd) compared to daratumumab, bortezomib, and dexamethasone (DVd).	Up to approximately 5 years
Minimal Residual Disease (MRD) negativity rate	Proportion of participants who achieve complete response (CR) or better and are MRD negative (defined at a sensitivity of a minimum of 1 in 105 nucleated cells by next generation flow cytometry).	Up to approximately 5 years
Overall Response Rate (ORR)	Calculated as percentage of participants who achieve best response of partial response (PR) or better according to the IMWG Uniform Response Criteria for multiple myeloma.	Up to approximately 5 years
Time to response (TTR)	Time from randomization to the first documentation of response (PR or better).	Up to approximately 5 years
Duration of Response (DoR)	Time from the first documentation of response (PR or better) to the first documentation of progressive disease (PD) or death due to any cause, whichever occurs first.	Up to approximately 5 years
Time to Progression (TTP)	The time from randomization to the first documented disease progression.	Up to approximately 5 years
Time to Next Treatment (TTNT)	Time from randomization to the start of the next antimyeloma treatment.	Up to approximately 5 years
Progression-free Survival 2 (PFS2)	Time from randomization to progression on the next anti-myeloma treatment or death due to any cause, whichever occurs first.	Up to approximately 5 years
Safety	Type, frequency, seriousness and severity of adverse events (AEs), and relationship of AEs to study treatment.	Up to approximately 5 years
European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30)	Mean changes from baseline in subscale scores in subject-reported health related quality of life outcomes and multiple myeloma-related symptoms as measured by the EORTC QLQ-C30.	Up to approximately 5 years
European Quality of Life Multiple Myeloma Module (EORTC QLQ-MY20)	EORTC QLQ-MY20 is a 20-item myeloma module intended for use among participants varying in disease stage and treatment modality. Mean changes from baseline in subscale scores in subject-reported health related quality of life outcomes and multiple myeloma-related symptoms as measured by the EORTC QLQ- MY20.	Up to approximately 5 years
Recommended iberdomide dose for Stage 2	Not Specified	Up to approximately 1 year
Area under the plasma concentration-time curve from time zero to tau (AUC(TAU))	Not Specified	Up to approximately 1 year
Maximum plasma concentration (Cmax)	Not Specified	Up to approximately 1 year
Time to maximum plasma concentration (Tmax)	Not Specified	Up to approximately 1 year

Frequently Asked Questions

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References

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