Trial · NCT04140162
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Participants Who Achieve MRD Negativity Either After Induction or, if Still MRD-positive After Induction, After Consolidation. | At the end of week 36 (post-consolidation therapy) | Of participants who complete at least one cycle of induction therapy, proportion that achieve MRD-negativity after completion of induction + those who achieve MRD-negativity after completion of consolidation (if still MRD-positive after induction). MRD status determined by International Myeloma Working Group (IMWG) Response Criteria. |
| Secondary | Overall Survival (OS) | Up to 3 years after start of study treatment | Time from initiation of daratumumab-based combination regimen until death or last follow-up date (whichever occurs first). |
| Secondary | Progression-free Survival (PFS) | Up to 3 years after start of study treatment | Time from initiation of daratumumab-based combination regimen to disease progression, where disease progression is according to the IMWG criteria, death, or last disease evaluation before the start of any subsequent anti-myeloma therapy (whichever occurs first). |
| Secondary | Proportion of Participants Who Were MRD-positive After Induction and Subsequently Achieve MRD-negative After Consolidation. | At the end of week 36 (post-consolidation therapy) | Of participants who are still MRD-positive after induction, proportion that achieve MRD-negative after consolidation. Per IMWG Response Criteria |
| Secondary | Proportion of Participants Who Maintain Post-induction MRD-negativity to Post-consolidation | At the end of week 36 (post-consolidation therapy) | Of participants who achieve post-induction MRD-negativity, proportion that maintain MRD-negativity through completion of consolidation therapy. |
| Secondary | Proportion of Participants Who Maintain Post-induction MRD-negativity to Post-consolidation. | At the end of week 88 (post 1 year of maintenance therapy) | Of participants who achieve post-induction MRD-negativity, proportion that maintain MRD-negativity through completion of 1 year of maintenance therapy. |
| Secondary | Proportion of Participants Who Maintain Post-induction MRD-negativity to Last Follow-up Visit. | After week 88, up to 3 years after start of study treatment | Of participants who achieve post-induction MRD-negativity, proportion that maintain MRD-negativity until last follow-up visit (if after week 88). |
| Secondary | Health-related Quality of Life Assessment Changes From Baseline Using EuroQol Survey "EQ-5D." | Baseline to 16 weeks post-last-dose of study treatment (Dara, R, V or d) | EQ-5D is a standardized participant-reported outcome measure developed by the EuroQol Group and used in this trial to assess health-related quality of life. |
| Secondary | Neurotoxicity Assessment Changes From Baseline Using Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) Questionnaire. | Baseline to 16 weeks post-last-dose of study treatment (Dara, R, V or d) | The FACT/GOG-Ntx is a patient-reported outcome measure used to assess health-related quality of life in patients undergoing cancer therapy, plus an eleven-item subscale (Ntx subscale) that evaluates symptoms and concerns associated specifically with chemotherapy-induced neuropathy. |
| Secondary | Incidence of Treatment-emergent Adverse Events | From start of study treatment (Dara-Rd) up to 30 days post last dose of study treatment (Dara, R, V or d) | Toxicity will be assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. |
| Secondary | Proportion of Participants With a Successful Stem Cell Mobilization After Receiving Dara-based Induction Therapy. | At the end of week 24 (post-induction therapy) | Of participants who have stem cells collected, proportion who have enough CD34+ cells after mobilization to be able to proceed with an autologous stem cell transplant (ASCT) if needed. Successful mobilization for each participant will be based on standard criteria at the institution where the transplant will be administered. |
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.
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