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NCT04091126: Phase 1 - Belantamab Mafodotin + Standard of Care New Multiple Myeloma (DREAMM 9) NDMM

Updated: Sep 19, 2022

DREAMM 9 - Transplant Ineligible - Newly Diagnosed Multiple Myeloma

DREAMM 9 belantamab

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.


GlaxoSmithKline 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

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DREAMM Clinical Trial Program (


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: Bortezomib

Drug: Lenalidomide

Drug: Dexamethasone


Belantamab Mafodotin (Code C114299)

Belantamab Mafodotin


Belantamab Mafodotin-blmf





COMY 22 - Session 15: Abstract communications


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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.

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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

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DREAMM-9: Phase III study of belantamab mafodotin plus VRd versus VRd alone in transplant-ineligible newly diagnosed multiple myeloma (TI NDMM).

DREAMM 9 - ASCO 2020 Poster



United States, Arizona

United States, Kansas

United States, North Carolina

United States, Wisconsin

Australia, New South Wales

Australia, Victoria

Canada, Alberta

Canada, Ontario


United Kingdom







Korea, Republic of




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