At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed multiple myeloma, with prior stem cell transplant or transplant ineligible status
- ✓At least 3 prior lines of anti-myeloma treatment including an IMiD, proteasome inhibitor, and anti-CD38 antibody
- ✓Measurable disease: serum M-protein ≥0.5 g/dL, or urine M-protein ≥200 mg/24h, or involved FLC ≥10 mg/dL with abnormal FLC ratio
- ✓Age ≥18 years
- ✕Prior anti-PD-1/PD-L1/PD-L2 therapy if discontinued due to Grade ≥3 immune-related adverse event
- ✕Current corneal epithelial disease except mild punctate keratopathy
- ✕Known active CNS metastases; previously treated metastases allowed if radiologically stable for ≥4 weeks and clinically stable without steroids ≥14 days
- ✕Known HIV infection
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I/II Single Arm Open-Label Study to Explore Safety and Clinical Activity of GSK2857916 Administered in Combination With Pembrolizumab in Subjects With Relapsed/Refractory Multiple Myeloma (DREAMM 4)
In Brief
A Phase 2 clinical trial evaluating belantamab mafodotin and Pembrolizumab for Multiple Myeloma. Completed, enrolled 41 participants across 12 sites in 4 countries.
Detailed Summary
This is a phase I/II, single arm, open label, two-part study that will assess safety, tolerability and clinical activity of GSK2857916 given in combination with a programmed cell death-1 (PD-1) inhibitor pembrolizumab in subjects with RRMM. This study will enroll adult subjects with RRMM, who have undergone stem cell transplant or who are considered transplant ineligible. Part 1 is a dose escalation phase to evaluate the safety and tolerability of escalating doses of GSK2857916 in combination with 200 milligrams (mg) pembrolizumab to establish the recommended phase 2 dose (RP2D). The following dose levels of GSK2857916 are planned to be studied: 2.5 milligrams per kilograms (mg/kg) (dose level \[DL\] 1) and 3.4 mg/kg (DL2). Part 2 is a dose expansion cohort. Once the RP2D has been identified, an expansion cohort will open for enrolment to confirm the safety profile and to evaluate the clinical activity of the combination. Up to 40 evaluable subjects will be enrolled in this two-part study (up to 12 in Part 1, and 28 in Part 2).
Study Details
Timeline
Interventions
belantamab mafodotin will be available as 20 milligrams per millilitre (mg/mL) solution for IV infusion, supplied as frozen liquid. belantamab mafodotin solution will be diluted in normal 0.9% saline to the appropriate concentration for the dose.
Pembrolizumab will be available as 100 mg/4 mL solution that should be stored under refrigeration at 2-8 degree Celsius. Pembrolizumab injection (solution) will be diluted prior to IV administration in 0.9% sodium chloride injection or 5% dextrose injection.