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RecruitingLast updated: 8 January 2024

DREAMM-20: This study aims to determine the recommended dose level, safety and effectiveness of a drug called belantamab when given alone and in combination with other treatments in people with multiple myelomaA 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

Clinical summary

Summary

This study has three parts.

Part 1 - Dose Escalation Phase in participants with relapsed or refractory multiple myeloma (RRMM): In this part, belantamab (bela) will be administered in participants with RRMM until progressive disease (PD). Participants may switch to Belamaf in case of PD.

Part 2 - Combination Treatments in participants with RRMM: In this part, 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.

Part 3 - Combination Treatments in participants with transplant-ineligible newly diagnosed multiple myeloma (TI-NDMM): In this part, participants with TI-NDMM will receive Bela-xRD and Belamaf-xRd. 

Conditions

This trial is treating patients with multiple myeloma

Cancer

Blood Cancers Haematological

Age

People18+

Phase

I

Trial Acronym

DREAMM-20

More information

Trial Identifiers

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Trial sponsor

GlaxoSmithKline

Scientific 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

Eligibility

Inclusion

  • 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

  • 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.

Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.
  • You have had a certain type of treatment or surgical procedure.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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