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Lenalidomide, Bortezomib and Dexamethasone Induction Therapy With Either Intravenous or Subcutaneous Isatuximab in Patients With Newly Diagnosed Multiple Myeloma

NCT05804032 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 514

Last updated 2026-02-18

No results posted yet for this study

Summary

The trial aims to demonstrate the non-inferiority of subcutaneous to intravenous isatuximab administration in transplant-eligible patients with newly diagnosed multiple myeloma.

Conditions

Interventions

DRUG

Isatuximab

IV isatuximab will be administered weekly in the first cycle (Cycle 1) on days 1, 8, 15, 22, 29, and biweekly on the 2 subsequent cycles at days 1, 15 and 29, at the dose of 10 mg/kg.

DRUG

Isatuximab

SC isatuximab will be administered on days 1, 8, 15, 22, 29 of cycle 1, and on days 1, 15 and 29 of cycles 2-3, at the dose of 1400 mg

DRUG

Lenalidomide

Both arms: 25 mg per os on day 1-14 and d22-35 in induction cycle 1-3

DRUG

Bortezomib

Both arms: 1.3 mg/m\^2 subcutaneous on day 1, 4, 8, 11, 22, 25, 29 32 in 3 induction cycles

DRUG

Dexamethasone

20 mg per os on day 1-2, 4-5, 8-9, 11-12, 15; and 22-23, 25-26, 29-30, 32-33 in induction cycles 1-3.

Sponsors & Collaborators

  • Deutsche Studiengruppe Multiples Myelom (DSMM)

    collaborator UNKNOWN

  • KKS Netzwerk

    collaborator NETWORK

  • Sanofi

    collaborator INDUSTRY

  • University of Heidelberg Medical Center

    lead OTHER

Principal Investigators

  • Hartmut Goldschmidt, Prof. · GMMG study group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-14
Primary Completion
2026-01-30
Completion
2026-01-30

Countries

  • Austria
  • Germany

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 NCT05804032 on ClinicalTrials.gov