Trial · NCT04822337
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Establish Maximum Tolerated Dose (MTD) | time to complete Cycle 1 (28 days) | DLTs will be determined for each subject enrolled in Phase I as a binary variable indicating whether the subject experienced a DLT during Cycle 1 of belantamab mafodotin-containing protocol directed induction therapy. |
| Primary | Evaluate Complete Response (CR) | up to 5 years | CR will be determined for each subject as a binary variable indicating whether the achieved a best overall response to induction therapy of CR or better. |
| Secondary | Complete Response (CR) | Up to 5 years | CR will be determined for each subject as a binary variable indicating whether the achieved a best overall response to induction therapy of CR or better |
| Secondary | Best Response | Up to 5 years | The best overall response will be determined as an ordered categorial variable indicating the subject's best response at any point along the treatment continuum. |
| Secondary | Very Good Partial Response (VGPR) | up to 5 year | will be determined for each subject as a binary variable indicating whether the achieved a best overall response to induction therapy of VGPR or better. |
| Secondary | Overall Response | up to 5 years post treatment discontinuation | The best overall response will be determined as an ordered categorial variable indicating the subject's best response at any point along the treatment continuum |
| Secondary | MRD Negative | Up to 5 years | . Minimal residual disease (MRD) (via NGF 10-5 and 10-6) will be determined for each subject after suspected CR for Phase I subjects and at the following timepoints for Phase II subjects: after induction therapy, after ASCT, and after 12 cycles of maintenance therapy (post Cycle 18visit) and every 12 months post Cycle 18 sample. |
| Secondary | Time to First Response (TTFR) | up to 30 days post treatment discontinuation | TTFR will be calculated for all subjects achieving an sCR, CR, VGPR, or PR. This will be defined as the time from initiation of belantamab mafodotin-containing protocol directed induction therapy to the time of first disease assessment indicating either sCR, CR, VGPR or PR |
| Secondary | Time to Best Response (TTBR) | up to 30 days post treatment discontinuation | Time to best response will be calculated for all subjects achieving an sCR, CR, VGPR or PR. This will be defined as the time from initiation of belantamab mafodotin-containing protocol directed induction therapy to the time of best disease assessment indicating either sCR, CR, VGPR or PR. |
| Secondary | Time to Progression (TTP) | Up to 5 years | TTP is defined as the duration of time from enrollment to the study (treatment start date) to first occurrence of progressive disease |
| Secondary | Duration of Response (DoR) | Up to 5 years post treatment response | DoR will be calculated for each subject achieving a PR or better and will be calculated from the time of the first assessment that identified response until disease progression or death. |
| Secondary | Overall Survival (OS) | Up to 8 years | OS is defined as the duration from enrollment to the study (treatment start date) to the date of death from any cause. |
| Secondary | Progression Free Survival (PFS) | Up to 8 years | PFS is defined as the duration of time from enrollment to the study (treatment start date) to first occurrence of either progressive disease or death (from any cause), whichever comes first. |
| Other | Safety - Serious Adverse Events (SAEs) | Up to 4-8 weeks post treatment discontinuation | The SAE variable will be determined for each subject as a binary variability indicating whether or not subject experienced a protocol-defined SAE. |
| Other | Safety - Adverse Events (AEs) | Up to 4-8 weeks post treatment discontinuation | The AE variable will be determined for each subject as a binary variability indicating whether or not subject experienced an AE per CTCAE V5.0. |
| Other | Safety - Adverse Events of Special Interest (AESIs) | Up to 4-8 weeks post treatment discontinuation | The AESI variable will be determined for each subject as a binary variability indicating whether or not subject experienced a protocol-defined AESI. |
| Other | Translational Research - PFS and OS | Up to 8 years | Describe subject outcomes of progression free survival and overall survival for MRD concordant and discordant cases |
| Other | Translational Research - MRD Status | Up to 8 years | Compare MRD status concordance between NGF and QiP mass spectrometry |
| Other | Translational Research - BCMA expression | Up to 8 years | Assess BCMA (B Cell Maturation Antigen) expression by plasma cells prior to therapy and at relapse using formalin-fixed paraffin embedded (FFPE) bone marrow biopsies. |
| Other | Translational Research - Immunologic Profiles | Up to 8 years | Establish peripheral blood and bone marrow immunologic profiles throughout therapy. |
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/NCT04822337/registered