Study of Single Agent Belantamab Mafodotin Versus Pomalidomide Plus Low-dose Dexamethasone (Pom/Dex) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)

Official Title

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

Summary:

This open-label, randomized study for evaluating the efficacy and safety of single agent belantamab mafodotin when compared to pom/dex in participants with RRMM. Participants will be randomized in a 2:1 ratio to receive either single agent belantamab mafodotin or pom/dex. Belantamab mafodotin will be administered intravenously at 2.5 milligram (mg)/kilogram (kg) on Day 1 (D1) of an every 3 weeks (Q3W) schedule. Pomalidomide will be administered orally at the approved starting dose of 4 mg daily on Days 1 to 21 of each 28-day cycle, with dexamethasone administered orally at a dose of 40 mg once weekly (Days 1, 8, 15, and 22). Participants in both arms will be treated until disease progression, death, unacceptable toxicity, withdrawal of consent, and lost to follow-up or end of study, whichever comes first. Approximately up to 380 participants will be randomized (320 + 60 to fulfill regional country requirements).

Trial Description

Primary Outcome:

  • Progression-free survival (PFS)
Secondary Outcome:
  • Overall survival (OS)
  • Overall response rate (ORR)
  • Clinical benefit rate (CBR)
  • Duration of response (DoR)
  • Time to response (TTR)
  • Time to progression (TTP)
  • Number of participants with adverse events (AEs)
  • Change from Baseline in hematology parameters: absolute white blood cell count (WBC), basophils,eosinophils, lymphocytes, monocytes, platelet count, and neutrophils (Giga cells per liter)
  • Change from Baseline in hematology parameters: Red Blood Cell (RBC) count and reticulocyte count (Trillion cells per liter)
  • Change from Baseline in hematology parameters: Mean Corpuscular Hemoglobin concentration (MCHC) and hemoglobin (Grams per Liter)
  • Change from Baseline in hematology parameters: Hematocrit (Proportion of red blood cells in blood)
  • Change from Baseline in hematology parameters: Mean Corpuscular Volume (MCV) [Femtoliter]
  • Change from Baseline in hematology parameters: Mean Corpuscular Hemoglobin (MCH) [Picograms]
  • Change from Baseline in clinical chemistry parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine kinase (CK), Gamma Glutamyl Transferase (GGT), and lactate dehydrogenase (LDH)
  • Change from Baseline in clinical chemistry parameters: Calcium, chloride, glucose, potassium, sodium, magnesium, blood urea nitrogen (BUN), and phosphorous (Millimoles per Liter)
  • Change from Baseline in clinical chemistry parameters: Creatinine, direct bilirubin, total bilirubin, uric acid (Micromoles per liter)
  • Change from Baseline in clinical chemistry parameters: Albumin and total protein (Grams per Liter)
  • Change from Baseline in Urinalysis Parameter: Specific Gravity (Ratio)
  • Change from Baseline in Urinalysis Parameters- Urine potential of hydrogen (pH) (Points on a scale)
  • Change from Baseline in urinalysis parameter: Glucose (Millimole per liter)
  • Change from Baseline in urinalysis parameter: Protein (Grams per liter)
  • Change from Baseline in urinalysis parameter: Ketones (Millimoles per liter)
  • Change from Baseline in urinalysis parameter: blood (10^9 cells per liter)
  • Change from Baseline in urinalysis parameter: creatinine/albumin ratio (ratio)
  • Number of participants with abnormal ocular findings
  • Plasma concentrations of belantamab mafodotin
  • Plasma concentrations of total monoclonal antibody (mAb)
  • Plasma concentrations of cys-mc Microtubular inhibitor monomethyl auristatin-F (MMAF)
  • Number of participants with Anti-drug antibody (ADAs) against belantamab mafodotin
  • Titer of ADAs against belantamab mafodotin
  • Number of participants with symptomatic adverse effects measured by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
  • Number of participants with symptomatic adverse effects measured by Ocular Surface Disease Index (OSDI)
  • European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core module (EORTC QLQC30) score
  • European Organization for Research and Treatment of Cancer IL52 (EORTC IL52) score
  • Rate of Minimal Residual Disease (MRD)

View this trial on ClinicalTrials.gov

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Resources

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