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

GlaxoSmithKline (GSK)

Status and phase: Enrolling; Phase 1

Conditions: Multiple Myeloma

Treatments: Drug: Dexamethasone; Drug: Belamaf; Drug: Bela; Drug: Standard of Care; Drug: Lenalidomide

Study type: Interventional

Funder types: Industry

Identifiers

NCT05714839

2022-501941-63 (EudraCT Number)

218670

Details and patient eligibility

About

The study consists of three parts

• Part 1: The primary purpose of this part is to determine the safety, and recommended part 2 dose of belantamab (bela) in participants with relapsed or refractory multiple myeloma (RRMM).
• Part 2: The primary purpose of this part is to determine safety, tolerability and percentage of adverse events (AEs) that happen to eyes in participants with RRMM treated with bela in combination with other treatments.
• Part 3: The primary objective of this part is to assess the safety, tolerability and rate of ocular AEs in participants with transplant-ineligible newly diagnosed multiple myeloma (TI-NDMM) treated with either belantamab mafodotin (belamaf) or bela in combination with other treatments.

Enrollment: 124 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 IMWG, and measurable disease.

• PART 1: Participants who have received at least 3 prior lines of anti-myeloma treatments, and have already received an immunomodulating agent, a proteasome inhibitor, and an anti-CD38 mAb (unless contraindicated or unavailable). Lines of therapy are defined by consensus panel of the International Myeloma Workshop.

• PART 2: Participants who meet all of the following:

• Have undergone Autologous stem cell transplant (ASCT) or are considered transplant ineligible

• Have been previously treated with at least ONE prior line of MM therapy

• Have documented disease progression during or after their most recent therapy

• PART 3: Participants who meet both of the following:

• NDMM with a requirement for treatment as documented per IMWG criteria

• Not considered a candidate for high dose chemotherapy with ASCT due to:

  1. Age ≥ 65 years OR
  2. Age 18-65 years with presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with ASCT or who refuse high-dose chemotherapy with ASCT as an initial treatment.

• Participants capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and protocol.

Exclusion criteria

• Diagnosis of primary Amyloid Light chain (AL) Amyloidosis, active Polyneuropathy, organomegaly, endocrinopathy, myeloma protein, and skin changes (POEMS) syndrome, primary plasma cell leukemia.
• Any serious and/or unstable pre-existing medical, psychiatric disorder, or other conditions (including lab abnormalities) that could interfere with participant's safety, obtaining informed consent, or compliance with study procedures.
• Active infection requiring antibiotic, antiviral, or antifungal treatment.
• Known, current drug or alcohol abuse.
• Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this trial, unless prospective Independent Review Board (IRB) approval (by chair or designee) is allowing exception to this criterion for a specific participant.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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124 participants in 3 patient groups

Part 1 - Dose Escalation Phase in Participants with RRMM

Experimental group

Description:

Bela will be administered in participants with RRMM until progressive disease (PD). Participants may switch to Belamaf in case of PD.

Treatment:

Drug: Bela

Drug: Belamaf

Part 2 - Combination Treatments in Participants with RRMM

Experimental group

Description:

Participants with RRMM will receive Bela-xRd and Belamaf-xRd. The combination treatment xRd includes lenalidomide (R) and dexamethasone (d). x will be either a standard of care (SoC) or an emerging treatment for Multiple Myeloma.

Treatment:

Drug: Standard of Care

Drug: Bela

Drug: Belamaf

Drug: Lenalidomide

Drug: Dexamethasone

Part 3 - Combination Treatments in Participants with TI-NDMM

Experimental group

Description:

Participants with TI-NDMM will receive Bela-xRd and Belamaf-xRd. The combination treatment xRd includes lenalidomide (R) and dexamethasone (d). x will be either a standard of care (SoC) or an emerging treatment for Multiple Myeloma.

Treatment:

Drug: Standard of Care

Drug: Bela

Drug: Belamaf

Drug: Lenalidomide

Drug: Dexamethasone