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

Multiple Myeloma Clinical Trial

— DREAMM-20  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05714839
• Other study ID #: 218670
• Secondary ID: 2022-501941-63
• Status: Recruiting
• Phase: Phase 1
• Start date: June 14, 2023
• Est. completion date: February 29, 2028

Study information

• Verified date: December 2023
• Source: GlaxoSmithKline
• Contact: US GSK Clinical Trials Call Center
• Phone: 877-379-3718
• Email: GSKClinicalSupportHD[@]gsk.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 124
• Est. completion date: February 29, 2028
• Est. primary completion date: September 29, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Bela
Bela will be administered.
• Belamaf
Belamaf will be administered.
• Lenalidomide
Lenalidomide will be administered.
• Dexamethasone
Dexamethasone will be administered.
• Standard of Care
Either standard of care (SoC) or an emerging treatment for Multiple Myeloma will be administered

Locations

Country	Name	City	State
Argentina	GSK Investigational Site	Ciudadela	Buenos Aires
Australia	GSK Investigational Site	Fitzroy	Victoria
Australia	GSK Investigational Site	Nedlands	Western Australia
Brazil	GSK Investigational Site	Salvador	Bahía
Brazil	GSK Investigational Site	São Paulo
Japan	GSK Investigational Site	Aomori
Japan	GSK Investigational Site	Osaka
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul, Korea
Mexico	GSK Investigational Site	Mexico City
Poland	GSK Investigational Site	Gdansk
Poland	GSK Investigational Site	Lublin
Taiwan	GSK Investigational Site	Changhua
Taiwan	GSK Investigational Site	Taipei
Turkey	GSK Investigational Site	Kayseri
United Kingdom	GSK Investigational Site	Leicester
United Kingdom	GSK Investigational Site	Oxford.

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Argentina,  Australia,  Brazil,  Japan,  Korea, Republic of,  Mexico,  Poland,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part 1, 2 and 3: Number of Participants with any Adverse Event		Up to 52 months
Primary	Part 1: Number of Participants with Dose Limiting Toxicities (DLTs)		Cycle 1 (Each cycle is of 28 days)
Primary	Part 1, 2 and 3: Number of Participants with Worst Case Grade Change from Baseline in Laboratory and Vital Sign Parameters		Up to 52 months
Primary	Part 2 and 3: Number of Participants with Corneal Adverse Events (CAEs)		Up to 52 months
Secondary	Part 1, 2 and 3: Observed Plasma Concentration of Bela		Up to 52 months
Secondary	Part 1, 2 and 3: Area Under the Curve (AUC) of Bela		Up to 52 months
Secondary	Part 1, 2 and 3: Maximum Concentration (Cmax) of Bela		Up to 52 months
Secondary	Part 1, 2 and 3: Number of Participants with Anti-Drug Antibodies (ADA) against Bela		Up to 52 months
Secondary	Part 1, 2 and 3: Titers of ADA against Bela		Up to 52 months
Secondary	Part 2 and 3: Number of Participants with ADAs against Belamaf		Up to 52 months
Secondary	Part 2 and 3: Titers of ADAs against Belamaf		Up to 52 months
Secondary	Part 1, 2 and 3: Objective Response Rate (ORR)	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.	Up to 52 months
Secondary	Part 2 and 3: Stringent Complete Response (sCR) Rate	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.	Up to 52 months
Secondary	Part 2 and 3: Complete Response (CR) Rate	CR rate is defined as the percentage of participants with a confirmed CR or better (i.e., CR, sCR) as per IMWG criteria.	Up to 52 months
Secondary	Part 2 and 3: Very Good Partial Response (VGPR) Rate	VGPR rate is defined as the percentage of participants with a confirmed VGPR or better (i.e., VGPR, CR, sCR) as per IMWG criteria.	Up to 52 months
Secondary	Part 2 and 3: Observed Plasma Concentration of Belamaf		Up to 52 months