To Evaluate Safety, Tolerability, and Clinical Activity of the Antibody-drug Conjugate, GSK2857916 Administered in Combination With Lenalidomide Plus Dexamethasone (Arm A), or in Combination With Bortezomib Plus Dexamethasone (Arm B) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)
Summary
This study will evaluate the safety and tolerability profile of belantamab mafodotin when administered in combination with approved regimens of either Lenalidomide Plus Dexamethasone \[Len/Dex (Treatment A)\] or Bortezomib Plus Dexamethasone \[Bor/Dex (Treatment B)\] in participants with RRMM, i.e., those who have relapsed or who are refractory to at least 1 line of approved therapy. Participants receiving treatment A, may continue combination treatment until the occurrence of progressive disease (PD), intolerable adverse events (AEs ), consent withdrawal, death or end of study. The participants receiving treatment B, may continue combination treatment for a total of up to 8 cycles. After 8 cycles of combination therapy, the participants will continue treatment with belantamab mafodotin, as a monotherapy until the occurrence of PD, intolerable AEs, consent withdrawal, death or end of study.
Timeline
- Start
- 2018-09-20
- Primary completion
- 2023-02-28
- Completion
- 2024-02-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Belantamab mafodotin | Monoclonal antibody | 1.9 mg/kg | — |
| Subject | Belantamab mafodotin | Monoclonal antibody | 2.5 mg/kg | — |
| Subject | Belantamab mafodotin | Monoclonal antibody | 3.4 mg/kg | — |
| Background | Bortezomib | Small molecule | 1.3 mg/m2 | Subcutaneous |
| Background | Dexamethasone | Small molecule | 20 mg | Oral |
| Background | Dexamethasone | Small molecule | 40 mg | Oral |
| Background | Lenalidomide | Other / unclassified | 10 mg | Oral |
| Background | Lenalidomide | Other / unclassified | 25 mg | Oral |