Actively Recruiting
A Phase 1 With Extension Cohort, Single Arm, Single Center, Open Label Trial of Belantamab Mafodotin for the Treatment of High-Risk Smoldering Multiple Myeloma
Led by M.D. Anderson Cancer Center · Updated on 2026-06-01
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and determining the recommended Phase 2 dose or maximum tolerated dose of Belantamab Mafodotin in patients with high-risk smoldering multiple myeloma, a condition characterized by abnormal plasma cells in the bone marrow. This Phase 1, single-center, single-arm study includes a dose-finding part and a dose-expansion part, aiming to enroll up to 30 patients. The study also assesses overall response rate and explores immune, cellular, and molecular profiles related to the treatment. Participants receive Belantamab Mafodotin intravenously over 30 to 60 minutes on Day 1 of each 56-day treatment cycle for the first 6 cycles. After identifying the maximum tolerated dose or recommended Phase 2 dose in the initial part, additional patients will be treated at that dose in the expansion phase. The study does not include a placebo group and is open-label. During the study, participants undergo evaluations including response assessments according to established criteria, safety monitoring, and exploratory tests such as bone marrow analysis, pharmacokinetics, and pharmacodynamics. The primary outcome is to establish the appropriate dose by the end of the study, with safety and treatment effects followed for about one year. Participants are monitored closely throughout treatment cycles to track response and side effects.
CONDITIONS
Brief Title
A Phase 1 With Extension Cohort, Single Arm, Single Center, Open Label Trial of Belantamab Mafodotin for the Treatment of High-Risk Smoldering Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with high-risk smoldering multiple myeloma confirmed by bone marrow plasmacytosis (≥10%), immunoparesis, and ≥95% aberrant plasma cells by flow cytometry
- Creatinine clearance (CrCl) of at least 30 ml/min
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 2
- Absolute neutrophil count (ANC) ≥ 1.0 x 10^9/L, hemoglobin no more than 2 grams below institutional normal, platelet count ≥ 90 x 10^9/L
- Adequate liver function: bilirubin ≤ 1.5 times upper limit of normal (ULN), AST and ALT ≤ 2.5 times ULN
- Females of childbearing potential agree to use highly effective contraception and have negative pregnancy tests before and during treatment
- Male participants agree to use contraception or abstain and not donate sperm during and after treatment period
- Able to give informed consent
- Newly diagnosed smoldering myeloma or no prior approved chemotherapy treatment for smoldering myeloma, except clinical trial or non-approved agents
You will not qualify if you...
- Evidence of myeloma-defining events or malignancy biomarkers such as hypercalcemia, renal insufficiency, severe anemia, bone lesions, high plasma cell percentage, abnormal serum free light chain ratio, or multiple focal lesions on MRI
- Treatment with corticosteroids (except stable inhaled or replacement therapy) or radiotherapy
- Prior or concurrent approved chemotherapy for smoldering multiple myeloma
- Plasma cell leukemia
- Pregnant or lactating females
- Active hepatitis B or C infection
- Known HIV infection
- Allergic reaction to drugs related to Belantamab Mafodotin
- Concurrent anti-cancer therapy
- Significant cardiovascular disease or uncontrolled arrhythmias
- Active infection or psychiatric/social conditions affecting compliance
- Contraindications to concomitant medications
- Major surgery within 1 month prior to enrollment
- Other malignancies unless stable for at least 2 years
- Active renal conditions affecting safety
- Active mucosal or internal bleeding
- Prior monoclonal antibody treatment within 30 days
- Cirrhosis or unstable liver/biliary disease
- Current corneal epithelial disease except mild changes
- Use of contact lenses during study except as directed
- Severe dry eye or monocular patients excluded
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 cycles of 56 days each
Participants receive belantamab mafodotin by vein over 30-60 minutes on Day 1 of each 56-day cycle for the first 6 cycles.
6 visits (in-person), one at the start of each treatment cycle
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
A
Astrid Murga
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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