Trial · NCT04975997
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) | Up to approximately 5 years | To compare the efficacy of iberdomide (also known as BMS-986382), daratumumab, and dexamethasone (IberDd) to that of daratumumab, bortezomib, and dexamethasone (DVd) in participants with relapsed or refractory multiple myeloma (RRMM) in terms of progression free survival (PFS). |
| Primary | Minimal Residual Disease (MRD) negative Complete Response (CR) at any time | Up to approximately 5 years | To compare the efficacy of iberdomide (also known as BMS-986382), daratumumab, and dexamethasone (IberDd) to that of daratumumab, bortezomib, and dexamethasone (DVd) in participants with relapsed or refractory multiple myeloma (RRMM) in terms of minimal residual disease (MRD) negative complete response (CR) at any time. |
| Secondary | Overall Survival (OS) | Up to approximately 5 years | 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). |
| Secondary | Sustainability of Minimal Residual Disease (MRD) negativity | Up to approximately 5 years | To evaluate the sustainability of minimal residual disease (MRD) negativity. |
| Secondary | Overall Response Rate (ORR) | Up to approximately 5 years | 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. |
| Secondary | Time to response (TTR) | Up to approximately 5 years | Time from randomization to the first documentation of response (PR or better). |
| Secondary | Duration of Response (DoR) | Up to approximately 5 years | 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. |
| Secondary | Time to Progression (TTP) | Up to approximately 5 years | The time from randomization to the first documented disease progression. |
| Secondary | Time to Next Treatment (TTNT) | Up to approximately 5 years | Time from randomization to the start of the next antimyeloma treatment. |
| Secondary | Progression-free Survival 2 (PFS2) | Up to approximately 5 years | Time from randomization to progression on the next anti-myeloma treatment or death due to any cause, whichever occurs first. |
| Secondary | Safety | Up to approximately 5 years | Type, frequency, seriousness and severity of adverse events (AEs), and relationship of AEs to study treatment. |
| Secondary | European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) | Up to approximately 5 years | 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. |
| Secondary | European Quality of Life Multiple Myeloma Module (EORTC QLQ-MY20) | Up to approximately 5 years | 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. |
| Secondary | Recommended iberdomide dose for Stage 2 | Up to approximately 1 year | |
| Secondary | Area under the plasma concentration-time curve from time zero to tau (AUC(TAU)) | Up to approximately 1 year | |
| Secondary | Maximum plasma concentration (Cmax) | Up to approximately 1 year | |
| Secondary | Time to maximum plasma concentration (Tmax) | Up to approximately 1 year |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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