Trial · NCT05730036
Registered outcomes64
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 64
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) per International Myeloma Working Group (IMWG) response criteria determined by Independent Review Committee (IRC) in CD38 antibody exposed participants | Up to approximatively 5 years | |
| Secondary | PFS per IMWG response criteria determined by IRC in all participants | Up to approximatively 5 years | |
| Secondary | Objective Response (OR) of Complete Response (CR) or better per IMWG response criteria as determined by IRC in CD38 antibody exposed participants | Up to approximatively 5 years | |
| Secondary | OR of CR or better per IMWG response criteria as determined by IRC in all participants | Up to approximatively 5 years | |
| Secondary | Overall Survival (OS) in participants previously exposed to CD38 antibodies | Up to approximatively 5 years | |
| Secondary | OS in all participants | Up to approximatively 5 years | |
| Secondary | Incidence of minimal residual disease (MRD) negative status in participants previously exposed to CD38 antibodies | Up to approximatively 5 years | |
| Secondary | Incidence of MRD negative status in all participants | Up to approximatively 5 years | |
| Secondary | Mean change in the worst pain score measured by Brief Pain Inventory-Short Form (BPI-SF) Item 3 in participants previously exposed to CD38 antibodies | Baseline to week 12 | The BPI-SF is a validated, self-administered questionnaire designed to measure a participant's perceived level of pain. The BPI-SF Item 3 uses a numeric rating scale to assess pain severity and pain interference in the past 24 hours. The numeric rating scale ranges from 0 (no pain) to 10 (worst imaginable pain), where higher scores indicate greater intensity of pain. |
| Secondary | Mean change in the worst pain score measured by BPI-SF Item 3 in all participants | Baseline to week 12 | The BPI-SF is a validated, self-administered questionnaire designed to measure a participant's perceived level of pain. The BPI-SF Item 3 uses a numeric rating scale to assess pain severity and pain interference in the past 24 hours. The numeric rating scale ranges from 0 (no pain) to 10 (worst imaginable pain), where higher scores indicate greater intensity of pain. |
| Secondary | Incidence of treatment emergent adverse events (TEAEs) in participants previously exposed to CD38 antibodies | Up to approximatively 5 years | |
| Secondary | Incidence TEAEs in all participants | Up to approximatively 5 years | |
| Secondary | Severity of TEAEs in participants previously exposed to CD38 antibodies | Up to approximatively 5 years | |
| Secondary | Severity of TEAEs in all participants | Up to approximatively 5 years | |
| Secondary | Incidence of adverse events of special interest (AESI) in participants previously exposed to CD38 antibodies | Up to approximatively 5 years | |
| Secondary | Incidence of AESI in all participants | Up to approximatively 5 years | |
| Secondary | Severity of AESI in participants previously exposed to CD38 antibodies | Up to approximatively 5 years | |
| Secondary | Severity AESI in all participants | Up to approximatively 5 years | |
| Secondary | Incidence of Serious Adverse Events (SAE) in participants previously exposed to CD38 antibodies | Up to approximatively 5 years | |
| Secondary | Incidence of SAE in all participants | Up to approximatively 5 years |
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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