Trial · NCT04091126
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 24
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Dose-limiting Toxicities (DLTs) of Belantamab Mafodotin | Up to 63 days | Criteria for DLT included hematologic indicators including Grade(G) 3-5 febrile neutropenia, G4 neutropenia \>7 days, G3 or greater thrombocytopenia accompanied by clinically significant bleeding; non-hematologic criteria, including Any G3/4 non-hematologic toxicity, G5 non hematologic toxicity, G3 or greater corneal toxicity; Liver toxicity meeting prespecified GSK liver stopping criteria. Severity was graded using National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. |
| Primary | Number of Participants With Adverse Events (AEs) | Up to approximately 284 weeks | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs were to be coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system. |
| Secondary | Lenalidomide Relative Dose Intensity (RDI) After Treatment With Belantamab Mafodotin in Combination With VRd | Up to 168 days | Relative Dose Intensity (RDI) is defined as the percentage of the amount of a drug actually delivered (actual dose intensity \[DI\]) relative to the amount planned (planned DI). |
| Secondary | Bortezomib RDI After Treatment With Belantamab Mafodotin in Combination With VRd | Up to 168 days | Relative Dose Intensity (RDI) is defined as the percentage of the amount of a drug actually delivered (actual dose intensity \[DI\]) relative to the amount planned (planned DI). |
| Secondary | Cumulative Administered Dose of Belantamab Mafodotin After Treatment in Combination With VRd | Up to 84 days | Cumulative Dose is sum of the actual dose administered during each infusion for a participant. |
| Secondary | Area Under the Concentration Time Curve From 0 to 504 Hours [AUC (0 - 504 Hours)] of Belantamab Mafodotin | Day 1 Cycle 1 Pre-Dose, End of Infusion (EOI); Anytime between Day 8 and Day 15 after Start of Infusion (SOI); Cycle 2 Day 1 Pre-Dose (up to Day 22 or at the end of the Cycle 1 dosing period) | Blood Samples were collected for Pharmacokinetic analysis of belantamab mafodotin. The last PK assessment used to derive AUC0-504h was intended to be collected approximately 504 hours (21 days) after the start of the first infusion. Depending on the dosing schedule, this assessment occurred either at the Day 22 visit (±3 days) for participants in the Q6/8W and Q9/12W cohorts or at the Cycle 2 Day 1 pre-dose visit for participants in the Q3W cohorts. Therefore, samples collected at Day 22 or Cycle 2 Day 1 predose represent the protocol-defined PK assessment performed at approximately 504 hours after Dose 1. |
| Secondary | Maximum Plasma Concentration (Cmax) of Belantamab Mafodotin | Day(D)1 Cycle(C)1 Pre-Dose(PD), End of Infusion(EOI), 2, 24, 72 Hours(h);Anytime D8-15 after Start of Infusion(SOI);22 days post-SOI;PD&EOI at D1 of C2-7,C10,C14-17; PD at D1 of C13,C23,C24, C27-29, C34, C39, C46; End of Treatment(~C52,up to ~234weeks) | Blood Samples were collected for Pharmacokinetic analysis of belantamab mafodotin. |
| Secondary | Time to Reach Cmax (Tmax) of Belantamab Mafodotin | Day(D)1 Cycle(C)1 Pre-Dose(PD), End of Infusion(EOI), 2, 24, 72 Hours(h);Anytime D8-15 after Start of Infusion(SOI);22 days post-SOI;PD&EOI at D1 of C2-7,C10,C14-17; PD at D1 of C13,C23,C24, C27-29, C34, C39, C46; End of Treatment(~C52,up to ~234weeks) | Blood Samples were collected for Pharmacokinetic analysis of belantamab mafodotin. |
| Secondary | Trough Concentration Prior to the Next Dose for Each Cycle (Ctrough) of Belantamab Mafodotin | Pre-dose at Day 1 of Cycle 1, 2, 3, 4, 5, 7, 10, 13, 14, 15, 16, 17, 23, 24, 27, 28, 29, 30, 31, 34, 36, 37, 41, 43, 49 | Blood Samples were collected for Pharmacokinetic analysis of belantamab mafodotin. C-trough were measured prior to the next dose for each cycle. |
| Secondary | Observed Plasma Concentration at the End of Infusion (C-EOI) of Belantamab Mafodotin | End of infusion at Day 1 on C1, C2, C3, C4, C5, C6, C7, C8, C9, C10, C11, C12, C13, C14, C15, C16, C17, C18, C19, C20, C21, C22, C24, C25, C26, C27 (up to approximately 81 weeks) | Blood Samples were collected for Pharmacokinetic analysis of belantamab mafodotin. |
| Secondary | Time of Last Observed Quantifiable Concentration (Tlast) of Belantamab Mafodotin | Day(D)1 Cycle(C)1 Pre-Dose(PD), End of Infusion(EOI), 2, 24, 72 Hours(h);Anytime D8-15 after Start of Infusion(SOI); Cycle 2 Day 1 Pre-Dose (up to Day 22 or at the end of the Cycle 1 dosing period) | Blood Samples were collected for Pharmacokinetic analysis of belantamab mafodotin. The last PK assessment used to derive Tlast was intended to be collected approximately 504 hours (21 days) after the start of the first infusion. Depending on the dosing schedule, this assessment occurred either at the Day 22 visit (±3 days) for participants in the Q6/8W and Q9/12W cohorts or at the Cycle 2 Day 1 pre-dose visit for participants in the Q3W cohorts. Therefore, samples collected at Day 22 or Cycle 2 Day 1 predose represent the protocol-defined PK assessment performed at approximately 504 hours after Dose 1. |
| Secondary | Clearance of Belantamab Mafodotin | Day(D)1 Cycle(C)1 Pre-Dose(PD), End of Infusion(EOI), 2, 24, 72 Hours(h);Anytime D8-15 after Start of Infusion(SOI);22 days post-SOI;PD&EOI at D1 of C2-7,C10,C14-17; PD at D1 of C13,C23,C24, C27-29, C34, C39, C46; End of Treatment(~C52,up to ~234weeks) | Blood Samples were collected for Pharmacokinetic analysis of belantamab mafodotin. |
| Secondary | Volume of Distribution at Steady State (Vss) of Belantamab Mafodotin | Day(D)1 Cycle(C)1 Pre-Dose(PD), End of Infusion(EOI), 2, 24, 72 Hours(h);Anytime D8-15 after Start of Infusion(SOI);22 days post-SOI;PD&EOI at D1 of C2-7,C10,C14-17; PD at D1 of C13,C23,C24, C27-29, C34, C39, C46; End of Treatment(~C52,up to ~234weeks) | Blood Samples were collected for Pharmacokinetic analysis of belantamab mafodotin. |
| Secondary | Apparent Terminal Half Life (t1/2) of Belantamab Mafodotin | Day(D)1 Cycle(C)1 Pre-Dose(PD), End of Infusion(EOI), 2, 24, 72 Hours(h);Anytime D8-15 after Start of Infusion(SOI);22 days post-SOI;PD&EOI at D1 of C2-7,C10,C14-17; PD at D1 of C13,C23,C24, C27-29, C34, C39, C46; End of Treatment(~C52,up to ~234weeks) | Blood Samples were collected for Pharmacokinetic analysis of belantamab mafodotin. |
| Secondary | AUC (0 - 504 Hour) of Cys-mcMMAF | Day 1 Cycle 1 Pre-Dose, End of Infusion (EOI); Anytime between Day 8 and Day 15 after Start of Infusion (SOI); Cycle 2 Day 1 Pre-Dose (up to Day 22 or at the end of the Cycle 1 dosing period) | Blood Samples were collected for Pharmacokinetic analysis of cys-mcMMAF. The last PK assessment used to derive AUC0-504h was intended to be collected approximately 504 hours (21 days) after the start of the first infusion. Depending on the dosing schedule, this assessment occurred either at the Day 22 visit (±3 days) for participants in the Q6/8W and Q9/12W cohorts or at the Cycle 2 Day 1 pre-dose visit for participants in the Q3W cohorts. Therefore, samples collected at Day 22 or Cycle 2 Day 1 predose represent the protocol-defined PK assessment performed at approximately 504 hours after Dose 1. |
| Secondary | Cmax of Cys-mcMMAF | D1 C1 Pre-Dose(PD), End of Infusion(EOI), 2, 24, 72h; D8-15 post Start of Infusion(SOI); 22d post-SOI; PD & EOI at D1 of C2-7,10,14-17,19,22,26; PD at D1 of C13,18,21,23,24,27-31,34,36,37,39,41,43,46,49; End of Treatment(EOT) (~C52, up to ~234weeks) | Blood Samples were collected for Pharmacokinetic analysis of cys-mcMMAF. |
| Secondary | Time to Reach Cmax (Tmax) of Cys-mcMMAF | Day(D)1 Cycle(C)1 Pre-Dose(PD), End of Infusion(EOI), 2, 24, 72 Hours(h);Anytime D8-15 after Start of Infusion(SOI);22 days post-SOI;PD&EOI at D1 of C2-7,C10,C14-17; PD at D1 of C13,C23,C24, C27-29, C34, C39, C46; End of Treatment(~C52,up to ~234weeks) | Blood Samples were collected for Pharmacokinetic analysis of cys-mcMMAF. |
| Secondary | Observed Plasma C-EOI of Cys-mcMMAF | End of infusion at Day 1 on C1, C2, C3, C4, C5, C6, C7, C8, C9, C10, C11, C12, C13, C14, C15, C16, C17, C18, C19, C20, C21, C22, C24, C25, C26, C27 (up to approximately 81 weeks) | Blood Samples were collected for Pharmacokinetic analysis of cys-mcMMAF. |
| Secondary | Tlast of Cys-mcMMAF | Day(D)1 Cycle(C)1 Pre-Dose(PD), End of Infusion(EOI), 2, 24, 72 Hours(h);Anytime D8-15 after Start of Infusion(SOI) | Blood Samples were collected for Pharmacokinetic analysis of cys-mcMMAF. |
| Secondary | Number of Participants With Positive Post-baseline Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin | Up to approximately 234 weeks | Serum samples were collected for the analysis of ADAs of anti-belantamab mafodotin. |
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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