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REST - Replacing Steroids in the Transplant Ineligble

NCT04939844 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2025-03-20

No results posted yet for this study

Summary

Newly diagnosed multiple myeloma patients ineligible for HD-ASCT will be included in the study. All participants will receive isatuximab in combination with bortezomib, lenalidomide and minimal dexamethasone until disease progression. The primary objective of this study is the MRD negativity rate during and/or after first 18 cycles of study treatment.

Conditions

Interventions

DRUG

Isatuximab, bortezomib, lenalidomide, dexamethason

All participants will receive the same treatment as described under arm.

Sponsors & Collaborators

  • Nordic Myeloma Study Group

    collaborator OTHER

  • St. Olavs Hospital

    collaborator OTHER

  • Helse Stavanger HF

    collaborator OTHER_GOV

  • Oslo University Hospital

    lead OTHER

Principal Investigators

  • Fredrik H Schjesvold, MD, PhD · Oslo University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-29
Primary Completion
2024-08-31
Completion
2024-08-31

Countries

  • Denmark
  • Norway

Study Locations

More Related Trials

Entities

Diseases

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 NCT04939844 on ClinicalTrials.gov