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)

Official Title

A Phase I/II, Open-label, Dose Escalation and Expansion Study to Evaluate Safety, Tolerability, and Clinical Activity of the Antibody-Drug Conjugate GSK2857916 Administered in Combination With Lenalidomide Plus Dexamethasone (Arm A), or Bortezomib Plus Dexamethasone (Arm B) in Participants With Relapsed / Refractory Multiple Myeloma - DREAMM-6

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 (Arm A)] or Bortezomib Plus Dexamethasone [Bor/Dex (Arm B)] in participants with RRMM, i.e., those who have relapsed or who are refractory to at least 1 line of approved therapy. Part 1 of the study will be a dose escalation phase to evaluate the safety and tolerability of up to 3 dose levels and up to 2 dosing schedules of belantamab mafodotin in combination with the two standard of care (SoC) regimens. Part 2 will further evaluate the safety and preliminary clinical activity of belantamab mafodotin at selected dose levels and dosing schedules in combination with Len/Dex or Bor/Dex. A total of 152 evaluable participants will be enrolled in the study with up to 27 in Part 1 and up to 125 in Part 2. Participants receiving treatment Arm 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 Arm 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.

Trial Description

Primary Outcome:

  • Number of participants with DLTs, Part 1, Treatment A
  • Number of participants with DLTs, Part 1, Treatment B
  • Number of participants with AEs and serious adverse events (SAEs), Part 1
  • Number of participants with electrocardiogram (ECG) parameters of potential clinical importance (PCI), Part 1
  • Number of participants with abnormal hematology parameters, Part 1
  • Number of participants with abnormal clinical chemistry parameters, Part 1
  • Number of participants with abnormal urinalysis parameters, Part 1
  • Number of participants with vital signs of PCI, Part 1
  • Number of participants with AEs and SAEs in Part 2
  • Overall Response Rate (ORR) as defined by the International Myeloma Working Group (IMWG) Uniform Response Criteria for multiple myeloma (MM), Part 2
Secondary Outcome:
  • Maximum plasma concentration (Cmax) for belantamab mafodotin, Part 1 and 2, Treatment A
  • Area under the concentration time curve (AUC) for belantamab mafodotin, Part 1 and 2, Treatment A
  • Time to maximum plasma concentration (Tmax) for belantamab mafodotin, Part 1 and 2, Treatment A
  • Serum half-life (t1/2) for belantamab mafodotin, Part 1 and 2, Treatment A
  • Cmax for belantamab mafodotin, Part 1 and 2, Treatment B
  • AUC for belantamab mafodotin, Part 1 and 2, Treatment B
  • Tmax for belantamab mafodotin, Part 1 and 2, Treatment B
  • t1/2 for belantamab mafodotin, Part 1 and 2, Treatment B
  • Cmax for Lenalidomide, Part 1 and 2, Treatment A
  • AUC for Lenalidomide, Part 1 and 2, Treatment A
  • Tmax for Lenalidomide, Part 1 and 2, Treatment A
  • t1/2 for Lenalidomide, Part 1 and 2, Treatment A
  • Cmax for Bortezomib, Part 1 and 2, Treatment B
  • AUC for Bortezomib, Part 1 and 2, Treatment B
  • Tmax for Bortezomib, Part 1 and 2, Treatment B
  • t1/2 for Bortezomib, Part 1 and 2, Treatment B
  • Number of participants with anti-drug antibodies (ADAs) against belantamab mafodotin, Part 1 and 2, Treatment A
  • Number of participants with ADAs, against belantamab mafodotin, Part 1 and 2, treatment B
  • Change from Baseline in symptoms and impacts as measured by Ocular Surface Disease Index (OSDI), Part 1 and 2
  • Change from Baseline in symptoms and impacts as measured by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25), Part 1 and 2
  • Change from Baseline in symptoms and impacts as measured by Patient-Reported Outcome Version of the Common Term Criteria for Adverse Events (PRO-CTCAE), Part 1 and 2
  • Number of participants with AEs and SAEs, Part 2
  • Number of participants with AEs of special interest (AESI), Part 1 and 2
  • Number of participants with ophthalmic findings on ophthalmic exam, Part 1 and 2
  • Change from Baseline in health related quality of life (HRQoL) as measured by European Organization for Research and Treatment of Cancer Quality of life Questionnaire 30-item core module (EORTC QLQ-C30), Part 1 and 2
  • Change from Baseline in HRQoL as measured by EORTC, 20-Item Multiple Myeloma Module (QLQ-MY20), Part 1 and 2

View this trial on ClinicalTrials.gov

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