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MInimal Residual Disease Adapted Strategy

NCT04934475 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 791

Last updated 2024-11-07

No results posted yet for this study

Summary

IFM 2020-02 will enroll patients eligible for ASCT less than 66 years. All patients will receive induction based on 6 cycles (28-day) of KRD-Isatuximab (Isa-KRD), in order to achieve deep responses and high MRD negativity rates. Patients will be classified at diagnosis according to cytogenetics (standard vs high-risk cytogenetics defined by the LP score including 17p deletion, t(4;14), del(1p32), gain 1q, trisomy 21 and trisomy 5).

Conditions

Interventions

DRUG

Isatuximab

Treatment with Isa-KRD during induction and consolidation , with Lenalidomide (Revlimid) or Iberdomide + Isatuximab during maintenance phase

PROCEDURE

ASCT

ASCT for ams B, C and D during consolidation

Sponsors & Collaborators

Principal Investigators

  • Philippe Moreau, Professor · Nantes University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

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

Timeline & Regulatory

Start
2021-12-08
Primary Completion
2024-09-30
Completion
2028-09-30
FDA Drug
Yes

Countries

  • Belgium
  • France
  • Reunion

Study Locations

More Related Trials

Entities

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 NCT04934475 on ClinicalTrials.gov