Trial · NCT04802356
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 | Incidence of deaths | Throughout the study period. Approximately 48 months | Number of patients that are exitus after start of the study treatment |
| Primary | Incidence of adverse events (AEs) | Throughout the study period. Approximately 48 months | Number of patients experiencing AEs, either treatment or non-treatment related, classified according to severity and graded according to NCTCAE V4.0 |
| Primary | Incidence of analytical alterations | Throughout the study period. Approximately 48 months | Changes in laboratory analytes from the hematology and blood chemistry panel after start of the study experimental treatment |
| Primary | Incidence of ocular events | Throughout the study period. Approximately 48 months | Number of patients experiencing ocular alterations after start of the study experimental treatment. |
| Secondary | Overall Response Rate (ORR) | Throughout the study period. Approximately 48 months | The percentage of participants with a confirmed partial response (PR) or better (PR, Very good partial response (VGPR), Complete response (CR), stringent complete response (sCR)). Assessed Q4W during induction, three months after ASCT, after consolidation, q4W during maintenance until PD, unacceptable toxicity, death, withdrawal of consent, loss to follow-up or end of the study. |
| Secondary | Complete Response Rate (CRR) | Throughout the study period. Approximately 48 months | The percentage of participants with a confirmed complete response (CR) or better (stringent complete response (CR, sCR)). Assessed Q4W during induction, three months after ASCT, after consolidation, q4W during maintenance until PD, unacceptable toxicity, death, withdrawal of consent, loss to follow-up or end of the study. |
| Secondary | Minimal Residual Disease (MRD) negativity rate | Throughout the study period. Approximately 48 months | The percentage of participants who are MRD negative by next-generation flow cytometry (NGF). MRD will be evaluated after each phase of treatment (induction, autologous stem cell transplant, consolidation and once a year during maintenance). If there is suspect of CR at any time different of those previously specified, the MRD should be evaluated at the suspicion of CR. Assessed Q4W during induction, three months after ASCT, after consolidation, q4W during maintenance until PD, unacceptable toxicity, death, withdrawal of consent, loss to follow-up or end of the study. |
| Secondary | Time to Response (TTR) | Throughout the study period. Approximately 48 months | The time from the date of inclusion and the first documented evidence of response (PR or better) among participants who achieve confirmed PR or better. |
| Secondary | Duration of Response (DoR) | Throughout the study period. Approximately 48 months | The time from first documented evidence of PR or better until progressive disease (PD) or death due to PD among participants who achieved PR or better. |
| Secondary | Progression-Free Survival (PFS) | Throughout the study period. Approximately 48 months | The time from the date of inclusion until the earliest date of documented disease progression or death due to any cause. |
| Secondary | Progression-Free Survival 2 (PFS2) | Throughout the study period. Approximately 48 months | The time from inclusion to disease progression after initiation of new anti-cancer therapy or death from any cause, whichever is earlier. If disease progression after new anti-cancer therapy cannot be measured, a PFS event is defined as the date of discontinuation of new anti-cancer therapy, or death from any cause, whichever is earlier. |
| Secondary | Overall Survival (OS) | Throughout the study period. Approximately 48 months | Defined as the time from the date of inclusion until the date of death due to any cause. |
| Secondary | Efficiency of hematopoietic stem cell collection | After cycle 4 of induction, 4 months after inclusion. | Number of CD34 cells collected after 2 induction cycles of treatment of belantamab mafodotin + 4 induction cycles of treatment of VRd. |
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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GET https://conductscience.org/api/trials/v1/NCT04802356/registered