Bortezomib, Isatuximab, Cyclophosphamide and Dexamethasone Induction in Transplant-Eligible Multiple Myeloma Patients With Renal Insufficiency

NCT04240054 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2026-01-28

No results posted yet for this study

Summary

This is a single-arm, open-label phase II study with a safety lead-in phase.

Conditions

Interventions

DRUG

Bortezomib

Bortezomib (1.5 mg/m\^2) subcutaneous on days 1, 8 and 15

DRUG

Isatuximab

Isatuximab (10 mg/kg) IV on days 1, 8, 15 and 22

DRUG

Cyclophosphamide

Cyclophosphamide (250 mg/m\^2) IV on days 1, 8 and 15

DRUG

Dexamethasone

Dexamethasone 20 mg PO or IV (10 mg if \>75 years) on days 1, 2, 8, 9, 15, 16, 22 and 23

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
2021-11-02
Primary Completion
2029-12-01
Completion
2030-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT04240054 on ClinicalTrials.gov