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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)
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).
Study details:
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).
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
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
DRUG: Iberdomide
DRUG: Iberdomide
Conditions
- • Multiple Myeloma
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
| DRUG: Dexamethasone
|
EXPERIMENTAL: Daratumumab in combination with Iberdomide and dexamethasone - Dose 2
| DRUG: Dexamethasone
|
EXPERIMENTAL: Daratumumab in combination with Iberdomide and dexamethasone - Dose 3
| DRUG: Dexamethasone
|
ACTIVE_COMPARATOR: Daratumumab in combination with dexamethasone and bortezomib
| DRUG: Dexamethasone
|
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 |
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