Last updated: 05/21/2026 15:30:12

A Study to Investigate the Safety and Efficacy of Belantamab for the Treatment of Multiple Myeloma When Used as Monotherapy and in Combination TreatmentsDREAMM-20

GSK study ID
218670
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Recruiting
Recruiting
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Phase 1/2 Open-label, Multicentre, Dose Escalation and Expansion Study to Investigate the Safety, Tolerability, and Clinical Activity of Belantamab as Monotherapy and in Combination With Other Treatments in Participants With Multiple Myeloma
Trial description: The study consists of three parts:
• Part 1 The primary purpose of this part aims to evaluate the safety, tolerability, and clinical activity of escalating doses of single agent Unconjugated belantamab antibody in participants with refractory multiple myeloma (RRMM) who have received at least 3 prior therapies (4L+).
• Part 2 The primary purpose of this part is to evaluate the safety, tolerability, and clinical activity of different dose ratios of belantamab mafodotin in combination with Unconjugated belantamab antibody (delivered as separate drugs) in participants with RRMM who have received at least 3 prior therapies (4L+).
• Part 3: The Primary purpose of this part will evaluate the clinical activity of a selected dose of the unconjugated belantamab antibody, either alone or in combination with belantamab mafodotin alongside the standard of care (SoC) pomalidomide-dexamethasone backbone. The study will focus on patients with multiple myeloma who have undergone at least one prior line of therapy, including treatment with lenalidomide.
Primary purpose:
Treatment
Trial design:
Sequential Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Part 1, 2 and 3: Number of Participants with any Adverse Event

Timeframe: Up to 52 months

Part 1: Number of Participants with Dose Limiting Toxicities (DLTs)

Timeframe: Cycle 1 (Each cycle is of 28 days)

Part 1, 2and 3: Number of Participants with Worst Case Grade Change from Baseline in Laboratory and Vital Sign Parameters

Timeframe: Up to 52 months

Part 1, 2 and 3: Number of Participants with severity of ocular events by the Keratopathy Visual Acuity (KVA) scale

Timeframe: Up to 52 months

Part 2: Overall Response Rate (ORR)

Timeframe: Up to 52 months

Part 3: Very Good Partial Response and better rate (VGPR+)

Timeframe: Up to 52 months

Secondary outcomes:

Part 1: Observed Plasma Concentration of belantamab

Timeframe: Up to 52 months

Part 1: Area Under the Curve (AUC) of belantamab

Timeframe: Up to 52 months

Part 1: Maximum Concentration (Cmax) of belantamab

Timeframe: Up to 52 months

Part 1: Number of Participants with Anti-Drug Antibodies (ADA) against belantamab

Timeframe: Up to 52 months

Part 1: Titers of ADA against belantamab

Timeframe: Up to 52 months

Part 1: Overall Response Rate (ORR)

Timeframe: Up to 52 months

Part 2: Duration of Response (DoR)

Timeframe: Up to 52 months

Part 2: Observed Plasma Concentration of Total belantamab

Timeframe: Up to 52 months

Part 2: Area Under the Curve (AUC) of Total belantamab

Timeframe: Up to 52 months

Part 1: Maximum Concentration (Cmax) of Total belantamab

Timeframe: Up to 52 months

Part 2: Observed Plasma Concentration of belantamab mafodotin (ADC)

Timeframe: Up to 52 months

Part 2: Area Under the Curve (AUC) of belantamab mafodotin (ADC)

Timeframe: Up to 52 months

Part 2: Maximum Concentration (Cmax) of belantamab mafodotin (ADC)

Timeframe: Up to 52 months

Part 2: Observed Plasma Concentration of Cys-Monomethyl Auristatin-F (Cys-mcMMAF)

Timeframe: Up to 52 months

Part 2: Area Under the Curve (AUC) of Cys-mcMMAF

Timeframe: Up to 52 months

Part 2: Maximum Concentration (Cmax) of Cys-mcMMAF

Timeframe: Up to 52 months

Part 2: Number of Participants with ADAs against Unconjugated belantamab antibody and belantamab mafodotin

Timeframe: Up to 52 months

Part 2: Titers of ADAs against Unconjugated belantamab antibody and belantamab mafodotin

Timeframe: Up to 52 months

Part 3: Minimal residual disease (MRD) negativity rate in participants achieving at least VGPR

Timeframe: Up to 52 months

Part 3: Overall Response Rate (ORR)

Timeframe: Up to 52 months

Part 3: Duration Of Response (DoR)

Timeframe: Up to 52 months

Part 3: Observed Plasma Concentration of Total belantamab

Timeframe: Up to 52 months

Part 3: Area Under the Curve (AUC) of Total belantamab

Timeframe: Up to 52 months

Part 3: Observed Plasma Concentration of belantamab mafodotin (ADC)

Timeframe: Up to 52 months

Part 3: Area Under the Curve (AUC) of belantamab mafodotin (ADC)

Timeframe: Up to 52 months

Part 3: Maximum Concentration (Cmax) of belantamab mafodotin (ADC)

Timeframe: Up to 52 months

Part 3: Observed Plasma Concentration of Cys-Monomethyl Auristatin-F (Cys-mcMMAF)

Timeframe: Up to 52 months

Part 3: Area Under the Curve (AUC) of Cys-mcMMAF

Timeframe: Up to 52 months

Part 3: Maximum Concentration (Cmax) of Cys-mcMMAF

Timeframe: Up to 52 months

Part 3: Number of Participants with ADAs against Unconjugated belantamab antibody and belantamab mafodotin

Timeframe: Up to 52 months

Part 3: Titers of ADAs against Unconjugated belantamab antibody and belantamab mafodotin

Timeframe: Up to 52 months

Interventions:
Drug: Unconjugated belantamab antibody
Drug: Belantamab mafodotin
Drug: Unconjugated belantamab antibody and belantamab mafodotin
Drug: Unconjugated belantamab antibody in combination with pomalidomide-dexamethasone backbone, with or without belantamab mafodotin
Enrollment:
152
Observational study model:
Not applicable
Primary completion date:
2029-03-12
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Multiple Myeloma
Product
Belantamab
Collaborators
Not applicable
Study date(s)
June 2023 to December 2029
Type
Interventional
Phase
1/2

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
  • Participants at the time of signing the Informed Consent Form (ICF) are at least 18 years old or are of the legal age of consent in the jurisdiction in which the study is taking place.
  • Participants who have histologically or cytologically confirmed diagnosis of Multiple Myeloma (MM), as defined by the international myeloma working group (IMWG) and have progressed on or following the last line of treatment Part 1 and Part 2: Participants who have received at least 3 prior lines of anti-myeloma treatments, , including lenalidomide, a proteasome inhibitor, and an anti-CD38 mAb either in combination or separately.
  • Diagnosis of primary Amyloid Light chain (AL) Amyloidosis, active Polyneuropathy, organomegaly, endocrinopathy, myeloma protein, and skin changes (POEMS) syndrome, primary plasma cell leukemia.
  • Part 3: Active or history of venous or arterial thromboembolism within the past 3 months. Contraindications to or unwilling to undergo protocol-required anti-thrombotic prophylaxis

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Aomori, Japan, 030-8553
Status
Recruiting
Location
GSK Investigational Site
Changhua, Unmapped, 500
Status
Recruiting
Location
GSK Investigational Site
Ciudadela, Argentina, B1702
Status
Study Complete
Location
GSK Investigational Site
Fitzroy, VIC, Australia, 3065
Status
Recruiting
Location
GSK Investigational Site
Leicester, Unmapped, LE1 5WW
Status
Recruiting
Location
GSK Investigational Site
Lublin, Poland, 20-081
Status
Recruiting
Location
GSK Investigational Site
Nedlands, WA, Australia, 6009
Status
Study Complete
Location
GSK Investigational Site
Osaka, Japan, 545-8586
Status
Study Complete
Location
GSK Investigational Site
Oxford, Unmapped, OX3 7LE
Status
Study Complete
Location
GSK Investigational Site
Salvador, Brazil, 41253-190
Status
Recruiting
Location
GSK Investigational Site
Seoul, Unmapped, 138-736
Status
Recruiting
Location
GSK Investigational Site
Seoul, Unmapped, 137-701
Status
Recruiting
Location
GSK Investigational Site
SAo Paulo, Brazil, 04537-080
Status
Recruiting
Location
GSK Investigational Site
Taipei, Unmapped, 100
Status
Recruiting
Location
GSK Investigational Site
Chiba, Japan, 277-8577
Status
Recruiting
Location
GSK Investigational Site
Tokyo, Japan, 105-8471
Status
Recruiting
Location
GSK Investigational Site
Viedma, Argentina, R8500ACE
Status
Recruiting
Location
GSK Investigational Site
Grand Rapids, MI, Unmapped, 49546
Status
Recruiting
Location
GSK Investigational Site
Plymouth, Unmapped, PL6 8DH
Status
Recruiting
Location
GSK Investigational Site
Gdansk, Poland, 80-214
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Joinville, Brazil, 89201-260
Status
Recruiting
Location
GSK Investigational Site
Nashville, TN, Unmapped, 37203
Status
Recruiting
Location
GSK Investigational Site
Istanbul, Turkey, 34010
Status
Recruiting
Location
GSK Investigational Site
Kayseri, Turkey, 38039
Status
Recruiting
Location
GSK Investigational Site
Florencio Varela, Argentina, B1888AAE
Status
Recruiting
Location
GSK Investigational Site
Chattanooga, TN, Unmapped, 37404
Status
Recruiting
Location
GSK Investigational Site
Chapel Hill, NC, Unmapped, 27514
Status
Recruiting
Location
GSK Investigational Site
Kaohsiung, Unmapped, 807
Status
Recruiting
Location
GSK Investigational Site
Yamagata, Japan, 990-9585
Status
Recruiting
Location
GSK Investigational Site
Kanagawa, Japan, 221-0855
Status
Recruiting

Study documents

No study documents available.

Results overview

Study Results yet to be posted

Recruitment status
Recruiting
Actual primary completion date
Not applicable
Actual study completion date
Not applicable

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

Additional information
Not applicable
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