NCT06461988

Talquetamab & Lenalidomide as Post Stem Cell Transplant Maintenance in Multiple Myeloma

An Open-Label, Non-Randomized, Phase II Study to Study the Efficacy of Talquetamab (JNJ-64407564) and Lenalidomide as Post Stem Cell Transplant Maintenance in Multiple Myeloma (OPTIMMAL)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a phase 2 study to evaluate the efficacy of talquetamab with a combination of lenalidomide, and to determine the safety and longitudinal patient reported symptoms and quality of life. Twenty participants with MM who plan to undergo or who have undergone autologous stem cell transplant as a part of their initial therapy and meet the eligibility criteria will be enrolled in the study.

Conditions

• Multiple Myeloma
• Post Stem Cell Transplant

Interventions

Type	Name	Description
DRUG	Talquetamab	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)

Timeline

• Start date: 2025-06-05
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2024-06-17
• Last updated: 2025-08-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study