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 2025-12-18
30
Participants Needed
1
Research Sites
245 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single-center, single arm, phase I study designed to determine the safety and find the recommended Phase 2 dose (RP2D) or maximum dose level (MTD) of Belantamab Mafodotin in patients with high-risk smoldering multiple myeloma. The study will have a dose-finding part and a dose-expansion part. The maximum number of enrolled patients will be 30 with 18 patients for the dose-finding part and 12 patients for the dose-expansion part. Once we determine the MTD or RP2D in the dose-finding part, we will enroll and treat 12 additional patients at the MTD or RP2D in the expansion part. Efficacy will be assessed through the overall response rate (ORR) at the end of the study. With the limited number of patients for the dose-expansion part, we will not have formal futility monitoring rule.
CONDITIONS
Official 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 all of the following: at least 10% plasma cells in bone marrow biopsy, immunoparesis (reduction in at least one uninvolved immunoglobulin), and 95% or more aberrant plasma cells by flow cytometry
- Creatinine clearance of 30 ml/min or higher calculated by MDRD equation
- Age 18 years or older
- ECOG performance status of 0 to 2
- Absolute neutrophil count of at least 1.0 x 10^9/L, hemoglobin no more than 2 grams below normal institutional levels, and platelet count of at least 90 x 10^9/L
- Adequate liver function with bilirubin no higher than 1.5 times the upper limit of normal and AST and ALT no higher than 2.5 times the upper limit of normal
- Females of childbearing potential must agree to use highly effective contraception and have negative pregnancy tests before and during the study
- Males must agree to use contraception or abstain from heterosexual intercourse during and for 6 months after treatment
- Able to give informed consent
- Newly diagnosed smoldering myeloma or no prior approved chemotherapy treatment for smoldering multiple myeloma; previous treatment in a clinical trial or with non-approved agents is allowed
You will not qualify if you...
- Evidence of myeloma-defining events or biomarkers such as hypercalcemia, renal insufficiency, anemia, bone lesions, high plasma cell percentage, abnormal free light chain ratio, or multiple focal lesions on MRI
- Use of corticosteroids except stable chronic inhaled steroids or replacement therapy; steroids allowed for infusion reactions
- Radiotherapy treatment
- Prior or concurrent treatment with approved chemotherapy agents for smoldering multiple myeloma
- Plasma cell leukemia
- Pregnant or lactating females
- Active hepatitis B or C infection
- Known HIV infection
- Known hypersensitivity to drugs related to belantamab mafodotin
- Concurrent anti-cancer therapy
- Significant cardiovascular disease including recent serious cardiac events or uncontrolled arrhythmias
- Uncontrolled illnesses or psychiatric/social conditions affecting compliance
- Contraindications to concomitant medications
- Major surgery within 1 month before enrollment
- Other malignancies unless stable for at least 2 years (except curatively treated non-melanoma skin cancer)
- Active renal conditions affecting safety except isolated proteinuria
- Active mucosal or internal bleeding
- Treatment with monoclonal antibody within 30 days before first dose
- Cirrhosis or unstable liver/biliary disease
- Current corneal epithelial disease except mild changes
- Use of contact lenses except directed by study doctor
- Severe dry eye or monocular patients
AI-Screening
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Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
A
Astrid Murga
CONTACT
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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