NCT04091126: Phase 1 - Belantamab Mafodotin + Standard of Care New Multiple Myeloma (DREAMM 9) NDMM
- Recruiting
- Dec 13, 2019
- 4 min read
Updated: Sep 19, 2022
DREAMM 9 - Transplant Ineligible - Newly Diagnosed Multiple Myeloma
Part 1:
Dose escalation and cohort expansion
Part 2:
Dose selection
Randomized Phase 3
Induction: BelaMaf selected dose + VRd (Cycle 1-8)
Maintenance: BelaMaf selected dose + Rd (Cycle 9+)
DREAMM-9 (NCT04091126) is a Phase I, open-label, randomized, dose and schedule evaluation study of belamaf + VRd in patients with TI NDMM. Eligible patients include those ≥18 years old with ECOG status 0–2 and adequate organ system functions. The study evaluates safety and tolerability of belamaf + VRd in up to 8 cohorts, up to 144 patients, to establish the recommended phase 3 dose (RP3D).
Study of Belantamab Mafodotin Plus Standard of Care (SoC) in Newly Diagnosed Multiple Myeloma (DREAMM 9)
This study will evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of belantamab mafodotin in combination with Velcade (bortezomib), Revlimid (lenalidomide), dexamethasone (VRd) and will determine recommended phase 3 dose (RP3D) in adult participants with newly diagnosed multiple myeloma (NDMM). Participants will receive the combination of bortezomib, lenalidomide and dexamethasone (VRd) on a 3-week cycle until cycle 8, followed by the combination of lenalidomide and dexamethasone (Rd) on a 4-week cycle thereafter as per dosing schedule.
Participants will receive belantamab mafodotin on a schedule that is dependent on the cohort to which they are assigned. This will be every cycle of VRd, every other cycle of VRd, or every third cycle of VRd. Belantamab may also be given as a 'split' dose, which is 50% of the dose on Day 1 and 50% of the dose on Day 8 of a cycle. Participants will complete an End of Treatment (EOT) visit at the point of study treatment discontinuation, followed by a Safety Follow-up visit 70 days after EOT.
Sponsor
ClinicalTrials.gov Identifier: NCT04091126
Official Title: 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 Myeloma
First Posted : September 16, 2019
Click here to see details on ClinicalTrials.gov
Drug: Belantamab mafodotin
Drug: Bortezomib
Drug: Lenalidomide
Drug: Dexamethasone
Belantamab Mafodotin (Code C114299)
Belantamab Mafodotin
BELANTAMAB MAFODOTIN
Belantamab Mafodotin-blmf
Blenrep
GSK2857916
J6M0-mcMMAF
COMY 22 - Session 15: Abstract communications
DREAMM-9: PHASE I STUDY OF BELANTAMAB MAFODOTIN (BELAMAF) PLUS STANDARD OF CARE (SOC) IN PATIENTS WITH TRANSPLANT-INELIGIBLE NEWLY DIAGNOSED MULTIPLE MYELOMA (TI-NDMM)
GSK showcases progress from the DREAMM clinical trial programme in multiple myeloma at the 2021 ASH Annual Meeting
18 November 2021: Issued: London UK
Data demonstrate potential of Blenrep (belantamab mafodotin-blmf) in combination with standard of care therapies in patients with newly diagnosed and relapsed/refractory multiple myeloma
GlaxoSmithKline (GSK) plc today announced 11 abstracts on Blenrep (belantamab mafodotin-blmf) will be presented at the upcoming American Society of Hematology (ASH) Annual Meeting and Exposition, to be hosted in Atlanta, Georgia, US and virtually from 11-14 December 2021. Presentations include updates from the DREAMM (DRiving Excellence in Approaches to Multiple Myeloma) clinical trial programme and two collaborative studies that will demonstrate the potential of belantamab mafodotin, a first-in-class anti-BCMA (B-cell maturation antigen) therapy, in multiple myeloma.
Key presentations at ASH include results from trials of belantamab mafodotin in combination with standard therapies in patients with newly diagnosed and relapsed/refractory multiple myeloma, including:
DREAMM-9 trial (poster #2738) highlighting outcomes of a quadruplet combination treatment regimen of belantamab mafodotin with bortezomib, lenalidomide and dexamethasone in transplant-ineligible patients with newly diagnosed multiple myeloma.
2738 DREAMM-9: Phase I Study of Belantamab Mafodotin Plus Standard of Care in Patients with Transplant-Ineligible Newly Diagnosed Multiple Myeloma
Program: Oral and Poster Abstracts
Session: 653. Myeloma and Plasma Cell Dyscrasias: Clinical-Prospective Therapeutic Trials: Poster II
Hematology Disease Topics & Pathways:
Clinical Trials, Clinical Research, Plasma Cell Disorders, Diseases, Lymphoid Malignancies
Sunday, December 12, 2021, 6:00 PM-8:00 PM
DREAMM-9: Phase III study of belantamab mafodotin plus VRd versus VRd alone in transplant-ineligible newly diagnosed multiple myeloma (TI NDMM).
Locations
United States, Arizona
United States, Kansas
United States, North Carolina
United States, Wisconsin
Australia, New South Wales
Australia, Victoria
Canada, Alberta
Canada, Ontario
Europe
United Kingdom
France
Germany
Italy
Poland
Spain
Asia
Korea, Republic of
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