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DREAMM8

Title A Phase III, 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 Myeloma
Therapeutic Area Multiple Myeloma
Principal Investigator Cindy Varga, MD
Min Age 18 Years
Gender Both
Contact NCCCR Staff
617-636-3264
NCCCR@tuftsmedicalcenter.org

Overview

The present study is evaluating whether the combined activity of belantamab mafodotin

at 2.5 mg/kg in Cycle 1 (C1) and 1.9 mg/kg in Cycle 2 onwards (C2+) when administered in combination with Pd could potentially translate into clinically meaningful benefits compared to PVd in RRMM participants who are progressing on or after treatment with a lenalidomide-containing regimen.

Study Details

Inclusion Criteria

  1. Have a confirmed diagnosis of multiple myeloma as defined by the IMWG criteria[Rajkumar, 2016],
  2. Have been previously treated with at least 1 prior line of MM therapy including a lenalidomide-containing regimen (lenalidomide must have been administered for at

                least 2 consecutive cycles) and must have documented disease progression during or after their most                                              recent therapy.

  3. Have undergone autologous stem cell transplant (SCT) or are considered transplant ineligible. Participants with a history of autologous SCT are eligible for study participation provided the following eligibility criteria are met:
  1. Autologous SCT was >100 days prior to the first dose of study medication
  2. No active bacterial, viral, or fungal infection(s) present

Exclusion Criteria

  1. Participants after prior allogeneic SCT.
    1. NOTE: Participants who have undergone syngeneic transplant will be allowedonly ifno history of or no currently active graft versus host disease (GvHD).
  2. Received prior BCMA targeted therapy.
  3. Systemic anti-myeloma therapy (including chemotherapy and systemic steroids)or use of an investigational drug within 14 days or five half-lives (whichever is shorter) preceding the firstdose of study drug; Prior treatment with a monoclonal antibodydrug within 30 days of receiving the first dose of study drugs.

Study Requirements

Participants are followed until death or the end of the study (5 years from last subject visit or when all participants have died, withdrawn consent ot have been lost to follow up), there will be 4 visits per cycle for cycles 1-8, and 2 visits per cycle from cycle 9 onward, blood will be drawn at each visit, imaging will include skeletal surveys, any other imaging needed for extramedullary disease if that is clinically indicated prior to study and PET/CT upon achieving MRD negativity by NGS, bone marrows will be done at screening along with an EKG. Several other research samples will be taken during blood draws.