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Isatuximab, Pomalidomide, Elotuzumab and Dexamethasone in Relapsed and/or Refractory Multiple Myeloma

NCT04835129 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2026-03-27

No results posted yet for this study

Summary

This is a multicenter, open-label phase II study in subjects with relapsed and/or refractory multiple myeloma with at least two prior lines of therapy. The main study consists of three phases: a 28-day screening phase, treatment phase that consists of 28-day cycles of isatuximab with elotuzumab, pomalidomide, and dexamethasone and a follow-up phase.

Conditions

Interventions

DRUG

Isatuximab (for run-in portion)

10 mg/kg IV on days 2, 8, 15, 22 of cycle 2 and days 1 and 15 of subsequent cycles.

DRUG

Isatuximab (for expansion)

10 mg/kg IV on days 2, 8, 15, 22 of cycle 1 and days 1 and 15 of subsequent cycles.

DRUG

Pomalidomide

4 mg PO days 1-21 of each cycle.

DRUG

Elotuzumab

10 mg/kg on days 1, 8, 15, 22 of cycles 1 and 2; 20 mg/kg on day 1 of subsequent cycles.

DRUG

Dexamethasone

40 mg (20 mg if \>75 years) PO or IV on days 1, 8,15 and 22 of each cycle.

Sponsors & Collaborators

  • Medical College of Wisconsin

    lead OTHER

Principal Investigators

  • Binod Dhakal, MD · Medical College of Wisconsin

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-10
Primary Completion
2027-04-01
Completion
2027-06-01
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 NCT04835129 on ClinicalTrials.gov