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

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05714839
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

GlaxoSmithKline
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

GSK Clinical Trials
Principal Investigator Affiliation GlaxoSmithKline
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Argentina, Australia, Brazil, Japan, Korea, Republic of, Mexico, Poland, Taiwan, Turkey, United Kingdom
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Myeloma
Arms & Interventions

Arms

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.

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.

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.

Interventions

Drug: - Bela

Bela will be administered.

Drug: - Belamaf

Belamaf will be administered.

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

GSK Investigational Site, Ciudadela, Buenos Aires, Argentina

Status

Recruiting

Address

GSK Investigational Site

Ciudadela, Buenos Aires, B1702

Site Contact

US GSK Clinical Trials Call Center

GSKClinicalSupportHD@gsk.com

877-379-3718

GSK Investigational Site, Fitzroy, Victoria, Australia

Status

Recruiting

Address

GSK Investigational Site

Fitzroy, Victoria, 3065

Site Contact

US GSK Clinical Trials Call Center

GSKClinicalSupportHD@gsk.com

877-379-3718

GSK Investigational Site, Nedlands, Western Australia, Australia

Status

Recruiting

Address

GSK Investigational Site

Nedlands, Western Australia, 6009

Site Contact

US GSK Clinical Trials Call Center

GSKClinicalSupportHD@gsk.com

877-379-3718

GSK Investigational Site, Salvador, Bahía, Brazil

Status

Recruiting

Address

GSK Investigational Site

Salvador, Bahía, 41253-190

Site Contact

US GSK Clinical Trials Call Center

GSKClinicalSupportHD@gsk.com

877-379-3718

GSK Investigational Site, São Paulo, Brazil

Status

Recruiting

Address

GSK Investigational Site

São Paulo, , 04537-080

Site Contact

US GSK Clinical Trials Call Center

GSKClinicalSupportHD@gsk.com

877-379-3718

GSK Investigational Site, Aomori, Japan

Status

Recruiting

Address

GSK Investigational Site

Aomori, , 030-8553

Site Contact

US GSK Clinical Trials Call Center

GSKClinicalSupportHD@gsk.com

877-379-3718

GSK Investigational Site, Osaka, Japan

Status

Recruiting

Address

GSK Investigational Site

Osaka, , 545-8586

Site Contact

US GSK Clinical Trials Call Center

GSKClinicalSupportHD@gsk.com

877-379-3718

GSK Investigational Site, Seoul, Korea, Korea, Republic of

Status

Recruiting

Address

GSK Investigational Site

Seoul, Korea, , 137-701

Site Contact

US GSK Clinical Trials Call Center

GSKClinicalSupportHD@gsk.com

877-379-3718

GSK Investigational Site, Seoul, Korea, Republic of

Status

Recruiting

Address

GSK Investigational Site

Seoul, , 138-736

Site Contact

US GSK Clinical Trials Call Center

GSKClinicalSupportHD@gsk.com

877-379-3718

GSK Investigational Site, Mexico City, Mexico

Status

Recruiting

Address

GSK Investigational Site

Mexico City, , 01330

Site Contact

US GSK Clinical Trials Call Center

GSKClinicalSupportHD@gsk.com

877-379-3718

GSK Investigational Site, Gdansk, Poland

Status

Recruiting

Address

GSK Investigational Site

Gdansk, , 80-214

Site Contact

US GSK Clinical Trials Call Center

GSKClinicalSupportHD@gsk.com

877-379-3718

GSK Investigational Site, Lublin, Poland

Status

Recruiting

Address

GSK Investigational Site

Lublin, , 20-081

Site Contact

US GSK Clinical Trials Call Center

GSKClinicalSupportHD@gsk.com

877-379-3718

GSK Investigational Site, Changhua, Taiwan

Status

Recruiting

Address

GSK Investigational Site

Changhua, , 500

Site Contact

US GSK Clinical Trials Call Center

GSKClinicalSupportHD@gsk.com

877-379-3718

GSK Investigational Site, Taipei, Taiwan

Status

Recruiting

Address

GSK Investigational Site

Taipei, , 100

Site Contact

US GSK Clinical Trials Call Center

GSKClinicalSupportHD@gsk.com

877-379-3718

GSK Investigational Site, Kayseri, Turkey

Status

Recruiting

Address

GSK Investigational Site

Kayseri, , 38039

Site Contact

US GSK Clinical Trials Call Center

GSKClinicalSupportHD@gsk.com

877-379-3718

GSK Investigational Site, Leicester, United Kingdom

Status

Recruiting

Address

GSK Investigational Site

Leicester, , LE1 5WW

Site Contact

US GSK Clinical Trials Call Center

GSKClinicalSupportHD@gsk.com

877-379-3718

GSK Investigational Site, Oxford., United Kingdom

Status

Recruiting

Address

GSK Investigational Site

Oxford., , OX3 7LE

Site Contact

US GSK Clinical Trials Call Center

GSKClinicalSupportHD@gsk.com

877-379-3718