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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05714839
Recruitment Status : Recruiting
First Posted : February 6, 2023
Last Update Posted : December 28, 2023
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Description
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Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Bela Drug: Belamaf Drug: Lenalidomide Drug: Dexamethasone Drug: Standard of Care Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 14, 2023
Estimated Primary Completion Date : September 29, 2027
Estimated Study Completion Date : February 29, 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
Drug Information available for: Belantamab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Part 1 - Dose Escalation Phase in Participants with RRMM
Bela will be administered in participants with RRMM until progressive disease (PD). Participants may switch to Belamaf in case of PD.
 Drug: Bela
Bela will be administered.
Other Names:
  • Belantamab
  • GSK2857914

Drug: Belamaf
Belamaf will be administered.
Other Names:
  • Belantamab mafodotin
  • GSK2857916 BLENREP
Experimental: Part 2 - Combination Treatments in Participants with RRMM
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.
 Drug: Bela
Bela will be administered.
Other Names:
  • Belantamab
  • GSK2857914

Drug: Belamaf
Belamaf will be administered.
Other Names:
  • Belantamab mafodotin
  • GSK2857916 BLENREP

Drug: Lenalidomide
Lenalidomide will be administered.

Drug: Dexamethasone
Dexamethasone will be administered.

Drug: Standard of Care
Either standard of care (SoC) or an emerging treatment for Multiple Myeloma will be administered
Experimental: Part 3 - Combination Treatments in Participants with TI-NDMM
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.
 Drug: Bela
Bela will be administered.
Other Names:
  • Belantamab
  • GSK2857914

Drug: Belamaf
Belamaf will be administered.
Other Names:
  • Belantamab mafodotin
  • GSK2857916 BLENREP

Drug: Lenalidomide
Lenalidomide will be administered.

Drug: Dexamethasone
Dexamethasone will be administered.

Drug: Standard of Care
Either standard of care (SoC) or an emerging treatment for Multiple Myeloma will be administered


Outcome Measures
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Primary Outcome Measures :
  1. Part 1, 2 and 3: Number of Participants with any Adverse Event [ Time Frame: Up to 52 months ]
  2. Part 1: Number of Participants with Dose Limiting Toxicities (DLTs) [ Time Frame: Cycle 1 (Each cycle is of 28 days) ]
  3. Part 1, 2 and 3: Number of Participants with Worst Case Grade Change from Baseline in Laboratory and Vital Sign Parameters [ Time Frame: Up to 52 months ]
  4. Part 2 and 3: Number of Participants with Corneal Adverse Events (CAEs) [ Time Frame: Up to 52 months ]

Secondary Outcome Measures :
  1. Part 1, 2 and 3: Observed Plasma Concentration of Bela [ Time Frame: Up to 52 months ]
  2. Part 1, 2 and 3: Area Under the Curve (AUC) of Bela [ Time Frame: Up to 52 months ]
  3. Part 1, 2 and 3: Maximum Concentration (Cmax) of Bela [ Time Frame: Up to 52 months ]
  4. Part 1, 2 and 3: Number of Participants with Anti-Drug Antibodies (ADA) against Bela [ Time Frame: Up to 52 months ]
  5. Part 1, 2 and 3: Titers of ADA against Bela [ Time Frame: Up to 52 months ]
  6. Part 2 and 3: Number of Participants with ADAs against Belamaf [ Time Frame: Up to 52 months ]
  7. Part 2 and 3: Titers of ADAs against Belamaf [ Time Frame: Up to 52 months ]
  8. Part 1, 2 and 3: Objective Response Rate (ORR) [ Time Frame: Up to 52 months ]
    ORR is defined as the percentage of participants with a confirmed Partial Response (PR) or better [i.e., PR, Very Good Partial Response (VGPR), Complete Response (CR), Stringent Complete Response (sCR)] as per International Myeloma Working Group (IMWG) criteria.

  9. Part 2 and 3: Stringent Complete Response (sCR) Rate [ Time Frame: Up to 52 months ]
    sCR is defined as the percentage of participants with CR plus normal free light chain ratio and absence of clonal cells in the bone marrow (BM) as per IMWG criteria.

  10. Part 2 and 3: Complete Response (CR) Rate [ Time Frame: Up to 52 months ]
    CR rate is defined as the percentage of participants with a confirmed CR or better (i.e., CR, sCR) as per IMWG criteria.

  11. Part 2 and 3: Very Good Partial Response (VGPR) Rate [ Time Frame: Up to 52 months ]
    VGPR rate is defined as the percentage of participants with a confirmed VGPR or better (i.e., VGPR, CR, sCR) as per IMWG criteria.

  12. Part 2 and 3: Observed Plasma Concentration of Belamaf [ Time Frame: Up to 52 months ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05714839


Contacts
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Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Center +44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com

Locations
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Argentina
GSK Investigational Site Recruiting
Ciudadela, Buenos Aires, Argentina, B1702
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Jorge Solimano         
Australia, Victoria
GSK Investigational Site Recruiting
Fitzroy, Victoria, Australia, 3065
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Hang Quach         
Australia, Western Australia
GSK Investigational Site Recruiting
Nedlands, Western Australia, Australia, 6009
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Bradley Augustson         
Brazil
GSK Investigational Site Recruiting
Salvador, Bahía, Brazil, 41253-190
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Edvan de Queiroz Crusoe         
GSK Investigational Site Recruiting
São Paulo, Brazil, 04537-080
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Vania Hungria         
Japan
GSK Investigational Site Recruiting
Aomori, Japan, 030-8553
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Kohmei Kubo         
GSK Investigational Site Recruiting
Osaka, Japan, 545-8586
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Teruhito Takakuwa         
Korea, Republic of
GSK Investigational Site Recruiting
Seoul, Korea, Korea, Republic of, 137-701
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Chang Ki Min         
GSK Investigational Site Recruiting
Seoul, Korea, Republic of, 138-736
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Dok Hyun Yoon         
Mexico
GSK Investigational Site Recruiting
Mexico City, Mexico, 01330
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Jorge Carlos Torres-Flores         
Poland
GSK Investigational Site Recruiting
Gdansk, Poland, 80-214
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Agata Tyczynska         
GSK Investigational Site Recruiting
Lublin, Poland, 20-081
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Marek Hus         
Taiwan
GSK Investigational Site Recruiting
Changhua, Taiwan, 500
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Hsuan-Yu Lin         
GSK Investigational Site Recruiting
Taipei, Taiwan, 100
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: SHANG YI Huang         
Turkey
GSK Investigational Site Recruiting
Kayseri, Turkey, 38039
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Ali Unal         
United Kingdom
GSK Investigational Site Recruiting
Leicester, United Kingdom, LE1 5WW
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Mamta Garg         
GSK Investigational Site Recruiting
Oxford., United Kingdom, OX3 7LE
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Karthik Ramasamy         
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
More Information
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT05714839    
Other Study ID Numbers: 218670
2022-501941-63 ( EudraCT Number )
First Posted: February 6, 2023    Key Record Dates
Last Update Posted: December 28, 2023
Last Verified: December 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
URL: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GlaxoSmithKline:
Bela
Belamaf
Belatamab
 Belantamab Mafodotin
Relapsed or Refractory Multiple Myeloma
Transplant-ineligible newly diagnosed multiple myeloma
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone
 Lenalidomide
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Immunologic Factors
Angiogenesis Inhibitors
Angiogenesis Modulating Agents