OncoMatch/Clinical Trials/NCT05091372
Minimal Residual Disease Guided Maintenance Therapy With Belantamab Mafodotin and Lenalidomide After Autologous Hematopoietic Cell Transplantation in Patients With Newly Diagnosed Multiple Myeloma
Is NCT05091372 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Belantamab mafodotin and Lenalidomide for myeloma multiple.
Treatment: Belantamab mafodotin · Lenalidomide — To increase the conversion rate from MRD-positive to MRD-negative CR in patients with newly diagnosed multiple myeloma (NDMM) receiving post-transplant maintenance therapy with belantamab mafodotin plus lenalidomide.
Check if I qualifyExtracted eligibility criteria
Cancer type
Multiple Myeloma
Prior therapy
Must have received: autologous hematopoietic cell transplant — first transplant
status post 1st auto-HCT (day 60 - 180 post-transplant)
Cannot have received: systemic anti-myeloma therapy (including systemic steroids)
Participant must not have used an investigational drug or approved systemic anti-myeloma therapy (including systemic steroids) within 14 days or five half-lives, whichever is shorter, preceding the first dose of study drug.
Cannot have received: monoclonal antibody
Participant must not have received prior treatment with a monoclonal antibody within 30 days of receiving the first dose of study drugs.
Lab requirements
Blood counts
All prior auto-HCT-related toxicities (NCI-CTCAE v5) must be ≤ Grade 1 at the time of enrollment except for alopecia, fatigue, and amenorrhea.
Kidney function
No active renal condition (infection, requirement for dialysis or any other condition that could affect participant's safety). Isolated proteinuria resulting from MM is allowed.
Liver function
No current unstable liver or biliary disease defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia due to underlying liver disease (serum albumin < 3gm/dL), esophageal or gastric varices, persistent jaundice, or cirrhosis. Stable non-cirrhotic chronic liver disease (including Gilbert's syndrome or asymptomatic gallstones) or hepatobiliary involvement of malignancy is acceptable.
Cardiac function
No evidence of current clinically significant uncontrolled arrhythmias, including clinically significant ECG abnormalities such as 2nd degree (Mobitz Type II) or 3rd degree AV block. No history of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within three (3) months of screening. No Class III or IV heart failure (NYHA). No uncontrolled hypertension (BP above goal despite three antihypertensive drug classes).
Adequate organ function (Please see Table 2. below). All prior auto-HCT- related toxicities (defined by National Cancer Institute - Common Toxicity Criteria for Adverse Events (NCI-CTCAE), version 5 must be ≤ Grade 1 at the time of enrollment except for alopecia, fatigue, and amenorrhea. Exclusion: current unstable liver or biliary disease, active renal condition, evidence of cardiovascular risk as defined.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- MD Anderson Cancer Center · Houston, Texas
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