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Elimination of Minimal Residual Disease After Transplant

NCT05690984 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-03-16

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Medical College of Wisconsin

    lead OTHER

Principal Investigators

  • Sabarinath Radhakrishnan, MD · Medical College of Wisconsin

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-26
Primary Completion
2026-06-30
Completion
2026-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05690984 on ClinicalTrials.gov