Trial · NCT07247097
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 Patients who test Negative for Minimal Residual Disease (MRD) at 10^-5 after 4 Treatment Cycles | Day 1 of Cycle 1 (each cycle is 28 days) to Day 28 of Cycle 4. | Evaluated at 1 x 10\^-5 using next generation sequencing (NGS) to detect clonal sequences. The proportions will be compared using the Cochran-Mantzel-Haenszel test, stratified by the randomization stratification factors. A one-sided significance level of 0.05 will be used. Patients without successful baseline minimal residual disease (MRD) testing will not be evaluated for MRD response. Proportion patients who test negative for MRD at 10\^-5 after 4 treatment cycles will be compared between the elran-RVd lite arm and the dara-RVd lite arm. |
| Secondary | Progression-Free Survival (PFS) | Day 1 of Cycle 1 (each cycle is 28 days) to documentation of disease progression or death from any cause (up to 5 years). Patients who have not progressed or died are censored at the date last known progression-free. | Progression-free survival (PFS) is the time from randomization to disease progression or death from any cause. PFS distributions will be calculated using the Kaplan-Meier method. PFS will be compared between the elran-RVd lite arm and the dara-RVd lite arm. |
| Secondary | Overall Survival (OS) | Day 1 of Cycle 1 (each cycle is 28 days) to documentation of death due to any cause or censored at the date last known alive, up to 5 years from study registration. | Overall survival (OS) is the time from start of treatment to death due to any cause. OS distributions will be calculated using the Kaplan-Meier method. OS will be compared between the elran-RVd lite arm and the dara-RVd lite arm. |
| Secondary | Overall Response Rate (ORR) | Day of initiation of first response to the first documentation of disease progression or death, up to 5 years after registration. Patients who have not progressed or died are censored at the date last known progression-free. | Overall response rate (ORR) is the proportion of patients achieving partial response or better, along with very good partial response and complete response per the International Myeloma Working Group Response Criteria (IMWG). All IMWG response categories will require one confirmation. ORR will be compared between the elran-RVd lite arm and the dara-RVd lite arm. |
| Secondary | Proportion Patients who test Negative for Minimal Residual Disease (MRD) at 10^-5 after 12 Treatment Cycles | Day 1 of Cycle 1 (each cycle is 28 days) to Day 28 of Cycle 12. | Evaluated at 1 x 10\^-5 using next generation sequencing (NGS) to detect clonal sequences. The proportions will be compared using the Cochran-Mantzel-Haenszel test, stratified by the randomization stratification factors. A one-sided significance level of 0.05 will be used. Patients without successful baseline minimal residual disease (MRD) testing will not be evaluated for MRD response. Proportion patients who test negative for MRD at 10\^-5 after 12 treatment cycles will be compared between the elran-RVd lite arm and the dara-RVd lite arm. |
| Secondary | Proportion Patients who test Negative for Minimal Residual Disease (MRD) at 10^-6 after 4 Treatment Cycles | Day 1 of Cycle 1 (each cycle is 28 days) to Day 28 of Cycle 4. | Evaluated at 1 x 10\^-6 using next generation sequencing (NGS) to detect clonal sequences. The proportions will be compared using the Cochran-Mantzel-Haenszel test, stratified by the randomization stratification factors. A one-sided significance level of 0.05 will be used. Patients without successful baseline minimal residual disease (MRD) testing will not be evaluated for MRD response. Proportion patients who test negative for MRD at 10\^-6 after 4 treatment cycles will be compared between the elran-RVd lite arm and the dara-RVd lite arm. |
| Secondary | Proportion Patients who Remain Negative for Minimal Residual Disease (MRD) at 10^-5 for 12 Months | Day of first negative MRD test to study completion (up to 5 years). | 12-month sustained MRD is defined as two MRD negative results a minimum of 12 months apart (with a window of four weeks). Evaluated at 1 x 10\^-5 using next generation sequencing (NGS) to detect clonal sequences. The proportions will be compared using the Cochran-Mantzel-Haenszel test, stratified by the randomization stratification factors. A one-sided significance level of 0.05 will be used. Patients without successful baseline minimal residual disease (MRD) testing will not be evaluated for MRD response. Proportion patients who remain negative for MRD at 10\^-5 for 12 months will be compared between the elran-RVd lite arm and the dara-RVd lite arm. |
| Secondary | Proportion Patients who Remain Negative for Minimal Residual Disease (MRD) at 10^-6 for 12 Months | Day of first negative MRD test to study completion (up to 5 years). | 12-month sustained MRD is defined as two MRD negative results a minimum of 12 months apart (with a window of four weeks). Evaluated at 1 x 10\^-6 using next generation sequencing (NGS) to detect clonal sequences. The proportions will be compared using the Cochran-Mantzel-Haenszel test, stratified by the randomization stratification factors. A one-sided significance level of 0.05 will be used. Patients without successful baseline minimal residual disease (MRD) testing will not be evaluated for MRD response. Proportion patients who remain negative for MRD at 10\^-6 for 12 months will be compared between the elran-RVd lite arm and the dara-RVd lite arm. |
| Secondary | Proportion Patients who test Negative for Minimal Residual Disease (MRD) at 10^-6 after 12 Treatment Cycles | Day 1 of Cycle 1 (each cycle is 28 days) to Day 28 of Cycle 12. | Evaluated at 1 x 10\^-6 using next generation sequencing (NGS) to detect clonal sequences. The proportions will be compared using the Cochran-Mantzel-Haenszel test, stratified by the randomization stratification factors. A one-sided significance level of 0.05 will be used. Patients without successful baseline minimal residual disease (MRD) testing will not be evaluated for MRD response. Proportion patients who test negative for MRD at 10\^-6 after 12 treatment cycles will be compared between the elran-RVd lite arm and the dara-RVd lite arm. |
| Secondary | Depth of Response using Peripheral Blood Mass Spectrometry | Day 1 of cycle 1 (each cycle is 28 days) to day 28 of cycle 24. | For the first 50 patients (including the safety run in patients), peripheral blood will be collected for monoclonal protein measurement by mass spectrometry. Mass spectrometry to measure serum monoclonal protein as a form of peripheral blood minimal residual disease (MRD) determination will be compared to the performance of an established assay for measuring minimal residual disease in the bone marrow using next generation sequencing (NGS) by Clonoseq at 10\^-5 threshold. The study will use spectrometry with a clonotypic-based approach using the M-Insight assay. |
| Secondary | Number of Patients who Experience Adverse Events (AEs) | Day 1 of cycle 1 (each cycle is 28 days) to day 28 of the patient's last treatment cycle (up to 48 cycles). | Assessed using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Assessment for cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) using the American Society for Transplantation and Cellular Therapy (ASTCT) criteria. Attribution of the adverse event (AE) will be determined as definite (clearly related to the study treatment), probably (likely related to the study treatment), possible (may be related to the study treatment), unlikely (doubtfully related to the study treatment), or unrelated (clearly not related to the study treatment). A "serious" adverse event is a regulatory definition and is based on subject or event outcome or action criteria usually associated with events that post a threat to a subject's life or functioning. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
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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