• Recruiting

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

Updated: Sep 19

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.


Sponsor

GlaxoSmithKline

 

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


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

GSK2857916

 

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)

Click here for details

 

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.

Learn more

 

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

Learn more

 

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

 

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

 

RELATED POSTS


DREAMM-1

NCT02064387: Phase 1 -Safety Pharm.kinetics Pharm.dynamics Img. & Cl. Activity GSK2857916 - DREAMM-1

Click here for details


DREAMM-2

NCT03525678: Phase 2 - Two Doses of GSK2857916 in Myeloma who have failed Anti-CD38 Ab. DREAMM 2

Click here for details


DREAMM-3

NCT04162210: Phase 3 - Belantamab Mafodotin Vs Pomalidomide + Low-dose Dexamethasone (Pom/Dex) RRMM

Click here for details


DREAMM-4

NCT03848845: Phase 1/2: GSK2857916 in Combination With Pembrolizumab in RRMM Myeloma- DREAMM 4

Click here for details


DREAMM-5

NCT04126200: Phase 1/2 - Belantamab Mafodotin as Monotherapy & With Anti-cancer Rx (RRMM) (DREAMM 5)

Click here for details


DREAMM-6

NCT03544281: Phase 2: GSK2857916 /Len/Dex Vs GSK2857916/Bortezomib/Dex - RRMM Myeloma - DREAMM 6

Click here for details


DREAMM-7

NCT04246047: Phase 3: Belantamab Mafodotin, Bortezomib and Dex RRMM Myeloma (DREAMM 7)

Click here for details


DREAMM-8

NCT04484623: Phase 3 - Belantamab Mafodotin & Pom/Dex (Pd) Vs Bortezomib & Pd in Ref. MM (DREAMM 8)

Click here for details


DREAMM-9

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

Click here for details


DREAMM-12

NCT04398745: Phase 1: Belantamab Mafodotin With Normal and Varying Degree of Impaired Renal Function

Click here for details


DREAMM-13

NCT04398680: Phase 1: Belantamab Mafodotin With Normal & Impaired Hepatic Function (DREAMM 13) RRMM

Click here for details


DREAMM-14

NCT05064358: Phase 2 - Alternative Dosing Regimens of Belantamab Mafodotin RRMM - (DREAMM 14)

Click here for details

 

NCT038282: Phase 1 - Dose Esc Study Belantamab mafodotin (GSK2857916) in Japanese With Refr MM

Click here for details


NCT03715478: Phase 1/2: Multi-Center Study of GSK2857916 With Pomalidomide & Dex - Algonquin trial

Click here for details


NCT04680468: Belantamab Mafodotin as Pre- and Post-autologous Stem Cell Transplant & Maintenance

Click here for details


NCT04822337: Phase 1/2 - Study of Carfilzomib, Len, Dex & Belantamab Mafodotin in Multiple Myeloma

Click here for details


NCT04802356: Phase 2: Belantamab Mafodotin in Newly Diagnosed Transplant Eligible Multiple Myeloma

Click here for details


NCT04808037: Phase 1/2: Blmf, Lenalidomide and Dexamethasone in Transplant-ineligible NDMM (BelaRd)

Click here for details


NCT05060627: Phase 1/2: Belantamab Mafodotin + Kd RRMM Multiple Myeloma, Refractory to Lenalidomide

Click here for details


AMaRC 19-02 - BelaCarD - Phase I/II - Study of combination belantamab maf, carfilzomib, Dex RRMM

Click here for details


NCT03732703: Phase 1/2: Myeloma-Developing Regimens Using Genomics (MyDRUG)

Click here for details




Posts Archive