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A Phase 2 Study of Isatuximab in Combination With Bortezomib, Cyclophosphamide and Dexamethasone Followed by Isatuximab and Lenalidomide Maintenance in Newly Diagnosed Patients With Multiple Myeloma and Severe Renal Impairment

NCT05147493 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2022-03-29

No results posted yet for this study

Summary

This is an Investigator-Initiated, phase 2, prospective, open-label study designed to be conducted in six hospitals in Greece.

Eligible patients will initially receive an induction phase of six 28-day cycles of isatuximab in combination with bortezomib, cyclophosphamide, and dexamethasone (VCd), followed by a maintenance phase with isatuximab and lenalidomide until disease progression, death, unacceptable adverse events, lost to follow up, or consent withdrawal, whichever occurs first. The study will last for approximately 36 months (follow-up period), starting from the date of the first patient in, to the date of the last patient last visit.

The primary objective is to assess the effect of induction treatment with isatuximab in combination with VCd on the renal function of newly diagnosed patients with multiple myeloma and severe renal impairment (RI).

The secondary objectives are to evaluate the effect of isatuximab in combination with VCd, followed by lenalidomide maintenance on: Overall response rate, Progression-Free Survival, Time to Response, Duration of Response, Overall Survival, Minimal Residual Disease negativity rate, Safety

Conditions

Interventions

DRUG

Isatuximab

Route of administration: Intravenous (IV). Dose regimen: Isatuximab will be given at a dose of 10 mg/kg once weekly (QW) on Days 1, 8, 15, and 22 in Cycle 1, on Days 1 and 15 during Cycles 2-6 and on Day 1 from Cycle 7 onwards.

DRUG

Bortezomib

Route of administration: Subcutaneous (SC). Dose regimen: Bortezomib will be given at 1.3 mg/m2 on Days 1, 4, 8, 11 of Cycle 1 and days 1, 8, 15, 22 of Cycles 2-6.

DRUG

Cyclophosphamide

Route of administration: Intravenous (IV). Dose regimen: Cyclophosphamide will be given at 300 mg/m2on Days 1, 8, 15 of Cycle 1 and days 1, 8, 15, 22 of Cycles 2-6.

DRUG

Dexamethasone

Route of administration: per os (PO)/Intravenous (IV). Dose regimen: Dexamethasone will be given at 40 mg (20 mg for ≥75 years old) on Days 1-4 and 9-12 of Cycle 1 and Days 1, 8, 15 and 22 of Cycles 2-6.

DRUG

Lenalidomide

Route of administration: per os (PO). Dose regimen: Lenalidomide will be given at 10 mg (or according to renal function) daily from Cycle 7 onwards.

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Hellenic Society of Hematology

    lead OTHER

Principal Investigators

  • Evangelos Terpos, Prof · Department of Clinical Therapeutics, School of Medicine, National Kapodistrian University of Athens (NKUA)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-30
Primary Completion
2024-12-31
Completion
2025-02-28

Countries

  • Greece

Study Locations

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Entities

Drugs
Diseases
Companies

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 NCT05147493 on ClinicalTrials.gov