Trial · NCT06931704
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Minimal Residual Disease negativity rate | At the beginning of cycle 13 (each cycle is 28 days) | Minimal Residual Disease negativity rate (10-6, NGS) status after 12 cycles of maintenance |
| Secondary | Safety and tolerability of Dara-Len and Elra-Len | 4 years | Presence and severity of Treatment-Emergent Adverse Events defined by National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (Number of Treatment-Emergent Adverse Events), except for Cytokine Release Syndrome and Immune effector Cell-Associated Neurotoxicity syndrome, which will be assessed based on American Society for Transplantation and Cellular Therapy guidelines. |
| Secondary | Progression-free survival | 4 years | Progression-free survival, defined as the time from randomization to the first occurrence of Progressive Disease, or death from any cause, whichever occurs first. Subjects alive and for whom disease progression has not been observed will be censored at the last date of follow-up. |
| Secondary | Minimal Residual Disease negativity with the threshold evaluated at one year after randomisation | At the beginning of cycle 13 (each cycle is 28 days) | Rate of Minimal Residual Disease status at one year after randomisation |
| Secondary | Minimal Residual Disease negativity with the threshold evaluated at one two years | At the beginning of cycle 25 (each cycle is 28 days) | Rate of Minimal Residual Disease status at two years after randomization |
| Secondary | Sustained Minimal Residual Disease negativity | At the beginning of cycle 13 and 25 (each cycle is 28 days) | Rate of patients with Minimal Residual Disease negative status during at least 12 months (at least two consecutive times) |
| Secondary | Complete Response or better | 4 years | The rate of complete response or better as defined by International Myeloma Working Group 2016 |
| Secondary | Overall survival | 4 years | Time from randomisation to the date of death due to any cause. Subjects alive will be censored at the last date of follow-up. |
| Secondary | Progression-free survival 2 | 4 years | Time from randomization to either second line Progressive Disease (assessed by investigator on the first subsequent line of antimyeloma therapy) or death, whichever occurs first. Subjects alive and for whom a second disease progression has not been observed will be censored at the last date of follow-up. |
| Secondary | Ability of return to work | At the beginning of cycle 1 (each cycle is 28 days), at 3 months, 6 months, 12 months, 24 months, 36 months and 48 months | Ability of return to work assessed by a specific questionnaire |
| Other | Determine biological prognostic factors influencing Minimal Residual Disease | At screnning (Baseline) | Value of biological prognostic factors (ISS Stage, Cytogenetics) |
| Other | Determine biological prognostic factors influencing complete response. | At screnning (Baseline) | Value of biological prognostic factors (ISS Stage, Cytogenetics) |
| Other | Descriptive quality of life | At Screening, At the beginning of every 3 cycles (each cycle is 28 days), at the beginning of cycle 24, and during the Follow-Up before Progressive Disease | Descriptive quality of life assessed by EQ-5D-5L and EORTC QLQ-C30 |
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
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT06931704/registered