NCT06376526

IMMUNOPLANT for Newly Diagnosed Multiple Myeloma

Immuno-consolidation for Newly Diagnosed Multiple Myeloma Using Lack of MRD Negativity After Initial cOmbination Therapy to Pursue Deeper Responses With Linvoseltamab ANd Delay Transplant

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Dickran Kazandjian, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether Linvoseltamab therapy in patients with newly diagnosed multiple myeloma will convert the disease status from minimal residual disease (MRD)-positive to MRD-negative, and increase the length of time that the disease is controlled. The researchers also want to find out the effects (good and bad) that Linvoseltamab has on participants and the condition.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
BIOLOGICAL	Linvoseltamab	Participants will be administered Linvoseltamab intravenously (IV), using a step-up dosing schedule as follows: * Cycle 1, Day 1: 5mg * Cycle 1, Day 8: 25mg * Cycle 1, Days 15 and 22: 200mg * Cycles 2 and 3, Days 1, 8, 15 and 22: 200mg * Cycle 4, Days 1 and 15: 200mg. For participants who are MRD-positive after four (4) cycles of study treatment: * Cycles 5 and 6, Days 1 and 15: 200 mg

Timeline

• Start date: 2024-08-21
• Primary completion: 2027-08-31
• Completion: 2029-08-31
• First posted: 2024-04-19
• Last updated: 2025-08-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study