All Japanese Population: Belantamab Mafodotin Plus Pomalidomide and Dexamethasone (Pd) Versus Bortezomib Plus Pd in Relapsed/Refractory Multiple Myeloma

NCT06956170 | Active Not Recruiting Phase 3 Results DMC FDA Drug

• 1 other identifier: 207499-JPN
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 13

Brief Summary

This study will evaluate the efficacy and safety of belantamab mafodotin in combination with pomalidomide and dexamethasone compared with that of combination of pomalidomide, bortezomib and dexamethasone in Japanese participants with relapsed/refractory multiple myeloma (RRMM).

Conditions

Multiple Myeloma

Keywords

Japan population; Belantamab Mafodotin; Relapsed/Refractory Multiple Myeloma; Pomalidomide; Dexamethasone; Bortezomib

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  PFS is defined as time from randomization until earliest date of disease progression (PD), determined by Independent Review Committee (IRC), according to the International Myeloma Working Group (IMWG) Response Criteria, or death due to any cause. PD is defined as increase of \>=25% from lowest value in \>=1 of following (serum M-protein \[absolute increase \>=0.5 grams per deciliter {g/dL}\]; serum M-protein increase \>=1g/dL \[when lowest M-protein \>=5g/dL\]; urine M-protein \[absolute increase \>=200 milligrams per 24 hours {mg/24h}\]; participants without measurable serum \& urine M-protein levels, difference between involved \& uninvolved serum free light chains (sFLC) levels \[absolute increase \>10mg/dL\]; appearance of new lesion,\>=50% increase from nadir in Sum of the products of the maximal perpendicular diameters of measured lesions (SPD) of \>1 lesion, or \>=50% increase in longest diameter of previous lesion \>1 centimeter (cm) in short axis.

  Up to approximately 120 weeks

Secondary Outcomes (28)

• Overall Survival (OS)

  Up to approximately 407 weeks

• Duration of Response (DoR)

  Up to approximately 407 weeks

• Minimal Residual Disease (MRD) Negativity Rate

  Up to approximately 407 weeks

• Overall Response Rate (ORR)

  Up to approximately 407 weeks

• Complete Response Rate (CRR)

  Up to approximately 407 weeks

Study Arms (2)

Belantamab mafodotin plus Pomalidomide and Dexamethasone

EXPERIMENTAL

Drug: Belantamab mafodotin; Drug: Pomalidomide; Drug: Dexamethasone

Bortezomib plus Pomalidomide and Dexamethasone

ACTIVE COMPARATOR

Drug: Pomalidomide; Drug: Dexamethasone; Drug: Bortezomib

Interventions

Belantamab mafodotin DRUG

Humanized anti-B-cell maturation antigen (BCMA) antibody/drug conjugate will be administered.

Belantamab mafodotin plus Pomalidomide and Dexamethasone

Pomalidomide DRUG

Immunomodulatory drug (IMiD) will be administered.

Belantamab mafodotin plus Pomalidomide and Dexamethasone; Bortezomib plus Pomalidomide and Dexamethasone

Dexamethasone DRUG

Synthetic glucocorticoid with anti-tumor activity will be administered.

Belantamab mafodotin plus Pomalidomide and Dexamethasone; Bortezomib plus Pomalidomide and Dexamethasone

Bortezomib DRUG

Proteasome Inhibitor will be administered.

Bortezomib plus Pomalidomide and Dexamethasone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Capable of giving signed informed consent.
• Male or female, 18 years or older.
• Have a confirmed diagnosis of multiple myeloma (MM) as defined by the International Myeloma Working Group (IMWG) criteria.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
• Have been previously treated with at least 1 prior line of MM therapy including a lenalidomide-containing regimen and must have documented disease progression during or after their most recent therapy. (Participants treated with lenalidomide ≥10 mg daily for at least 2 consecutive cycles are eligible).
• Must have at least 1 aspect of measurable disease defined as one of the following;
• Urine M-protein excretion greater than or equal to (≥)200 milligrams (mg) per 24-hour, or
• Serum M-protein concentration ≥0.5 grams/deciliters (g/dL) (≥5.0 g/liter \[L\]), or
• Serum free light chain (FLC) assay: involved FLC level ≥10 mg/dL (≥100 mg/L) and an abnormal serum free light chain ratio (less than \[\<\]0.26 or greater than \[\>\]1.65) only if participant has no measurable urine or serum M spike.
• Have undergone autologous stem cell transplant (ASCT) or are considered transplant ineligible. Participants with a history of ASCT are eligible for study participation provided the following eligibility criteria are met: a. ASCT was \>100 days prior to the first dose of study medication. b. No active bacterial, viral, or fungal infection(s) present
• All prior treatment-related toxicities (defined by National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI-CTCAE\] version 5.0) must be less than or equal to (≤)Grade 1 at the time of enrolment, except for alopecia.
• Adequate organ system functions as mentioned in the protocol.
• Male and female participants agree to abide by protocol-defined contraceptive requirements.

You may not qualify if:

• Active plasma cell leukemia, symptomatic amyloidosis or active polyneuropathy, organomegaly, endocrinopathy, monoclonal plasma proliferative disorder, and skin changes (POEMS) syndrome at the time of screening.
• Prior allogeneic SCT.
• Systemic anti-myeloma therapy (including chemotherapy and systemic steroids) within 14 days or five half-lives (whichever is shorter) preceding the first dose of study drug; prior treatment with a monoclonal antibody drug within 30 days of receiving the first dose of study drugs.
• Plasmapheresis within 7 days prior to the first dose of study drug.
• Received prior treatment with or intolerant to pomalidomide.
• Received prior Beta cell maturation antigen (BCMA) targeted therapy.
• Intolerant to bortezomib or refractory to bortezomib (for example; participant experienced progressive disease during treatment, or within 60 days of completing treatment, with a bortezomib-containing regimen of 1.3 mg/meter square \[m\^2\] twice weekly).
• Evidence of cardiovascular risk including any of the following;
• Evidence of current clinically significant untreated arrhythmias, including clinically significant electrocardiogram abnormalities including second degree (Mobitz type II) or third degree atrioventricular (AV) block.
• Recent history within (3 months of screening) of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting .
• Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system
• Uncontrolled hypertension.
• Any major surgery within the last 4 weeks.
• Previous or concurrent invasive malignancy other than multiple myeloma, except:
• The disease must be considered medically stable for at least 2 years; or

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (13)

GSK Investigational Site

Nagoya, Aichi-ken, 467-8602, Japan

Location

GSK Investigational Site

Kamogawa, Chiba, 296-8602, Japan

Location

GSK Investigational Site

Kashiwa, Chiba, 277-8567, Japan

Location

GSK Investigational Site

Matsuyama, Ehime, 790-8524, Japan

Location

GSK Investigation Site

Fukushima, Fukushima, 960-1295, Japan

Location

GSK Investigational Site

Maebashi, Gunma, 371-8511, Japan

Location

GSK Investigational Site

Shibukawa, Gunma, 377-0280, Japan

Location

GSK Investigational Site

Numakunai, Iwate, 028-3695, Japan

Location

GSK Investigational Site

Okayama, Okayama-ken, 701-1192, Japan

Location

GSK Investigational Site

Osaka, Osaka, 565-0871, Japan

Location

GSK Investigational Site

Tottori-shi, Tottori, 683-8504, Japan

Location

GSK Investigational Site

Yamagata, Yamagata, 990-9585, Japan

Location

GSK Investigational Site

Hokkaido, 060-8648, Japan

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

belantamab mafodotin; pomalidomide; Dexamethasone; Bortezomib

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2025
• First Posted: May 4, 2025
• Study Start: February 10, 2022
• Primary Completion: May 27, 2024
• Study Completion (Estimated): November 30, 2029
• Last Updated: June 11, 2025
• Results First Posted: June 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

JP (13)