Talquetamab & Lenalidomide as Post Stem Cell Transplant Maintenance in Multiple Myeloma
NCT06461988 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2025-08-24
Summary
Multiple myeloma (MM) is a heterogenous plasma cell malignancy characterized by clonal proliferation of plasma cells and organ damage. Autologous transplantation with high dose chemotherapy is the standard of care in frontline treatment of eligible patients with MM.
Conditions
- Multiple Myeloma
- Post Stem Cell Transplant
Interventions
- DRUG
-
Talquetamab Step up dosing: C1D1: 10 mcg/kg C1D3: 60 mcg/kg C1D5: 400 mcg/kg C1D15: 800 mcg/kg Talquetamab 800 mg/kg SC Q4W in 28-day cycle for Cycles 2-13
- DRUG
-
Talquetamab and Lenalidomide
Lenalidomide 10 mg, 3 weeks on 1 week off, until PD/ intolerance, C2-13 (Lenalidomide 5 mg for creatinine clearance 30-60 ml/min)
Sponsors & Collaborators
-
Janssen Scientific Affairs, LLC
collaborator INDUSTRY - lead OTHER
Principal Investigators
-
Surbhi Sidana, MD · Stanford University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 19 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-06-05
- Primary Completion
- 2026-06-30
- Completion
- 2026-06-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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