NCT05690984

Elimination of Minimal Residual Disease After Transplant

Combination Post-transplant Consolidation Therapy With Isatuximab, Lenalidomide, Dexamethasone (IsaRD) in Multiple Myeloma Patients With Persistent Marrow Minimal Residual Disease (Elimination of MRD After Transplant; E-MAT)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single-center, single-arm, phase II study that will enroll multiple myeloma (MM) patients with persistent bone marrow minimal residual disease (MRD) post autologous stem cell transplant (ASCT) irrespective of the International Myeloma Working Group (IMWG) response.

Detailed description

Thirty study subjects will be enrolled at Froedtert Hospital and the Medical College of Wisconsin Cancer Center. Enrolled subjects will receive a combination of isatuximab, lenalidomide, and dexamethasone (IsaRD) for 12 28-day cycles. The primary objective of this study is to determine bone marrow (BM) MRD ≤1x10\^5 negativity rate, as measured by the clonoSEQ® next-generation sequencing (NGS) assay, at the end of 12 months of IsaRD treatment. Other objectives will further assess efficacy, tolerability, and molecular response to the IsaRD regimen.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Dexamethasone	Dexamethasone will be used for the double purpose of premedication and therapeutic effect. On Day 1 of Cycle 1, subjects will be administered 40 mg dexamethasone as an IV infusion. On Days 8, 15, 22 of Cycle 1 and Days 1 and 15 of Cycles 2-4, dexamethasone will be given as a single oral dose of 40 mg. For Cycles 5-12, dexamethasone will be given as a single oral dose of 4 mg on Days 1 and 15.
DRUG	Isatuximab	Following premedication (if applicable), subjects will be given isatuximab 10 mg/kg body weight as an intravenous (IV) infusion on Days 1, 8, 15, and 22 (i.e., weekly) during Cycle 1 and on Days 1 and 15 (i.e., Q2W) during Cycles 2-12.
DRUG	Lenalidomide	On Days 1-21 for all 12 cycles, lenalidomide will be given to subjects as a single daily oral dose.

Timeline

• Start date: 2023-06-26
• Primary completion: 2026-06-01
• Completion: 2026-07-01
• First posted: 2023-01-19
• Last updated: 2026-03-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study