Last updated: 01/22/2026 06:30:09

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:
    153
    Primary completion date:
    2029-03-12
    Observational study model:
    Not applicable
    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

    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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