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NDMM Patients Candidates for ASCT Comparing Extended VRD Plus vs. Isa-VRD vs. Isa-V-Iberdomide

NCT05558319 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 480

Last updated 2022-09-28

No results posted yet for this study

Summary

This is a Phase III open-label, 3-arm, parallel, randomized, controlled trial. The allocation ratio 1:1:1 and outcome assessment are blind to group allocation. Patients will be randomized from 3 arms. Patients will receive VRD extended + ASCT plus ERI or Isatuximab-VRD + ASCT or Isatuximab-VID + ASCT.

Conditions

  • Newly Diagnosed Multiple Myeloma

Interventions

DRUG

Bortezomib

Bortezomib

DRUG

Isatuximab

Isatuximab

DRUG

Iberdomide

Iberdomide

DRUG

Lenalidomide

Lenalidomide

DRUG

Dexamethasone

Dexamethasone

Sponsors & Collaborators

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • Sanofi

    collaborator INDUSTRY

  • Adknoma

    collaborator UNKNOWN

  • Start from scratch

    collaborator UNKNOWN

  • PETHEMA Foundation

    lead OTHER

Principal Investigators

  • Juan José Lahuerta Palacios, Dr · Hospital Universitario 12 de Octubre

  • Joan Bladé, Dr · Hospital Clinic of Barcelona

  • Mª Victoria Mateos, Dr · Hospital Clínico Universitario de Salamanca

  • Enrique M Ocio, Dr · Hospital Universitario Marqués de Valdecilla

  • Jesús San Miguel, Dr · Clínica Universitaria de Navarra

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-10-31
Primary Completion
2027-04-30
Completion
2029-04-30

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs
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 NCT05558319 on ClinicalTrials.gov