DREAMM

DREAMM 4

A Phase 1/2 Single Arm Open-Label Study to Explore Safety and Clinical Activity of Belantamab Mafodotin Administered in Combination With Pembrolizumab in Subjects With Relapsed/Refractory Multiple Myeloma2

DREAMM 4

This is a phase 1/2, single arm, open label, two-part study that will assess safety, tolerability and clinical activity of belantamab mafodotin 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 belantamab mafodotin in combination with 200 milligrams (mg) pembrolizumab to establish the recommended phase 2 dose (RP2D). The following dose levels of belantamab mafodotin 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).

DREAMM 4 Study Design

Belantamab Mafodotin is there for you

Help us drive excellence in approaches to multiple myeloma with the support, tools, and educational resources for anyone considering belantamab mafodotin.

DREAMM 4 is currently active, not recruiting with an estimated study completion date of July 17, 2023

Other Trials You May Be Interested In

DREAMM 3

A Phase 3, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Single Agent Belantamab Mafodotin Compared to Pomalidomide Plus Low dose Dexamethasone (Pom/Dex) in Participants With Relapsed/Refractory Multiple Myeloma1

DREAMM 5

A Phase 1/2, Randomized, Open-label Platform Study Utilizing a Master Protocol to Study Belantamab Mafodotin as Monotherapy and in Combination With Anticancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma3

DREAMM 6

A Phase 1/2, Open-label, Dose Escalation and Expansion Study to Evaluate Safety, Tolerability, and Clinical Activity of the Antibody-Drug Conjugate Belantamab Mafodotin Administered in Combination With Lenalidomide Plus Dexamethasone (Arm A), or Bortezomib Plus Dexamethasone (Arm B) in Participants With Relapsed/Refractory Multiple Myeloma4,5

DREAMM 7

A Multicenter, Open-Label, Randomized Phase 3 Study to Evaluate the Efficacy and Safety of the Combination of Belantamab Mafodotin, Bortezomib, and Dexamethasone (B-Vd) Compared With the Combination of Daratumumab, Bortezomib and Dexamethasone (D-Vd) in Participants With Relapsed/Refractory Multiple Myeloma6

DREAMM 8

A Phase 3, Multicenter, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination With Pomalidomide and Dexamethasone (B-Pd) Versus Pomalidomide Plus Bortezomib and Dexamethasone (PVd) in Participants With Relapsed/Refractory Multiple Myeloma7

DREAMM 9

A Phase 1, Randomized, Dose and Schedule Evaluation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of Belantamab Mafodotin Administered in Combination With Standard of Care in Participants With Newly Diagnosed Multiple Myeloma8

DREAMM 12

A Phase 1 Study to Evaluate the Pharmacokinetics and Safety of Belantamab Mafodotin Monotherapy in Participants With Relapsed or Refractory Multiple Myeloma Who Have Normal and Varying Degrees of Impaired Renal Function9

DREAMM 13

A Phase 1 Study to Evaluate the Pharmacokinetics and Safety of Belantamab Mafodotin Monotherapy in Participants With Relapsed or Refractory Multiple Myeloma Who Have Normal and Varying Degrees of Impaired Hepatic Function10

DREAMM 14

A Phase 2, Randomized, Parallel, Open-label Study to Investigate the Safety, Efficacy, and Pharmacokinetics of Various Dosing Regimens of Single-agent Belantamab Mafodotin in Participants With Relapsed or Refractory Multiple Myeloma11

DREAMM

SE-GBL-BLM-WCNT-200008 June 2022

This information is intended for healthcare providers only. This website includes ongoing clinical trials for both approved and investigational compounds. Some agents are approved in select indications. Inclusion in this website does not imply regulatory approval for these compounds or all indications. Information about all trials can be found at www.clinicaltrials.gov. All clinical study information updated as of May 2021.

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