- Active, not recruiting
NCT03544281: Phase 2: GSK2857916 /Len/Dex Vs GSK2857916/Bortezomib/Dex - RRMM Myeloma - DREAMM 6
Updated: Sep 19, 2022
NCT03544281: Phase 2: 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) (DREAMM 6)
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) (DREAMM 6)
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.
Sponsor
Collaborator
Iqvia Pty Ltd
ClinicalTrials.gov Identifier: NCT03544281
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
First Posted : June 1, 2018
Click here for details on ClinicalTrials.gov
DREAMM Clinical Trial Program (dreammtrials.com)
Bortezomib : National Cancer Institute
Bortezomib : MedlinePlus Drug Information
Lenalidomide: National Cancer Institute
Lenalidomide: MedlinePlus Drug Information
Dexamethasone : National Cancer Institute
Dexamethasone : MedlinePlus Drug Information
Belantamab mafodotin : National Cancer Institute
Belantamab mafodotin : MedlinePlus Drug Information
Drug: Belantamab mafodotin
Drug: Lenalidomide
Drug: Dexamethasone
Drug: Bortezomib
Belantamab Mafodotin (Code C114299)
Belantamab Mafodotin
BELANTAMAB MAFODOTIN
Belantamab Mafodotin-blmf
Blenrep
GSK2857916
J6M0-mcMMAF
1419 DREAMM-6: Safety, Tolerability and Clinical Activity of Belantamab Mafodotin (Belamaf) in Combination with Bortezomib/Dexamethasone (BorDex) in Relapsed/Refractory Multiple Myeloma (RRMM)
Program: Oral and Poster Abstracts
Session: 653. Myeloma/Amyloidosis: Therapy, excluding Transplantation: Poster I
Hematology Disease Topics & Pathways:
Adult, Diseases, Therapies, Combinations, Lymphoid Malignancies, Study Population, Clinically relevant
Saturday, December 5, 2020, 7:00 AM-3:30 PM
DREAMM-6: SAFETY AND TOLERABILITY OF BELANTAMAB MAFODOTIN IN COMBINATION WITH BORTEZOMIB/DEXAMETHASONE IN RELAPSED/REFRACTORY MULTIPLE MYELOMA (RRMM)
Locations
United States, Alabama
United States, Arizona
United States, Georgia
United States, Indiana
United States, Michigan
United States, Missouri
United States, Nebraska
United States, New Jersey
United States, New York
United States, South Carolina
United States, Texas
Canada, Quebec
Australia, New South Wales
Australia, South Australia
Australia, Victoria
Australia, Western Australia
Europe
United Kingdom
France
Spain
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