ClinicaliQ Trial Snapshot
- A Study of Belantamab Mafodotin Administered in Combination With Lenalidomide and Dexamethasone (BRd) Versus Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma (NDMM) Who Are Ineligible for Autologous Stem Cell Transplantation (TI-NDMM) — Recruiting • Phase III •….
- What is being tested: This Phase 3 trial compares belantamab mafodotin combined with lenalidomide and dexamethasone (BRd) against daratumumab combined with lenalidomide and dexamethasone (DRd) in newly diagnosed multiple myeloma patients ineligible for stem cell transplantation, with primary endpoints of progression-free survival….
- Patient eligibility overview: The study focuses on newly diagnosed multiple myeloma patients who cannot undergo autologous stem cell transplantation due to age, comorbidities, or patient preference—representing a substantial proportion of the myeloma population requiring non-transplant treatment strategies.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
The purpose of this Phase 3 study is to evaluate if BRd prolongs progression free survival (PFS) and/or improves minimal residual disease (MRD) negative status compared with DRd in participants with TI-NDMM.
Eligibility Snapshot
- : 1. Is at least 18 or the legal age of consent in the jurisdiction in which the study is taking place, at the time of signing the informed consent. 2. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and in the protocol. 3. NDMM with a requirement for treatment as documented per IMWG criteria. 4. Must have at least 1 aspect of measurable disease, as assessed by the central laboratory, defined as 1 of the following: 1. Urine M-protein excretion ≥200 mg/24 hours (≥0.2 g/24 hours) And/or 2. Serum M-protein concentration ≥0.5 g/dL (≥5.0 g/L) And/or 3. Serum free light-chain (FLC) assay: involved FLC level ≥10 mg/dL (≥100 mg/L) and an abnormal serum FLC ratio (1.65). 5. Newly diagnosed and not considered candidate for high-dose chemotherapy with autologous stem cell transplant (ASCT) due to any of the following: 1. Exclusion from treatment with ASCT due to country- or site-specific age restriction. 2. Presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with ASCT. 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 7. Adequate organ system function…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.