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Compare Lenalidomide and Subcutaneous Daratumumab vs Lenalidomide and Dexamethasone in Frail Subjects With Previously Untreated Multiple Myeloma Who Are Ineligible for High Dose Therapy

NCT03993912 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 294

Last updated 2026-04-07

No results posted yet for this study

Summary

This is a Phase 3, randomized (study drug assigned by chance), open-label (participants and researchers are aware about the treatment, participants are receiving), active-controlled (study in which the experimental treatment or procedure is compared to a standard treatment or procedure), parallel-group (each group of participants will be treated at the same time), and multicenter (when more than one hospital team work on a medical research study) study in participants with newly diagnosed multiple myeloma (a blood cancer of plasma cells) and who are not candidates for high dose chemotherapy (treatment of disease, usually cancer, by chemical agents) and autologous stem cell transplant (ASCT). The primary hypothesis of this study is that subcutaneous Daratumumab in combination with Lenalidomide will prolong progression-free survival and likely induce less toxicity as compared with Lenalidomide and dexamethasone, in elderly frail subjects with newly diagnosed Multiple myeloma who are ineligible for high dose chemotherapy and ASCT

Conditions

Interventions

DRUG

Daratumumab SC in combination with Lenalidomide

Daratumumab SC 1800 mg * once every week for 8 weeks * then once every other week for 16 weeks * thereafter once every 4 weeks, until progression

DRUG

Lenalidomide PO (25mg)

Lenalidomide PO (25mg): days 1 through 21 of each 28-day cycle, until progression

DRUG

Dexamethasone PO (20mg): days 1, 8, 15, 22 of each 28-day cycle, until progression

Dexamethasone PO (20mg): days 1, 8, 15, 22 of each 28-day cycle, until progression

Sponsors & Collaborators

  • University Hospital, Lille

    lead OTHER

Principal Investigators

  • Thierry Facon, MD,PhD · University Hospital, Lille

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-17
Primary Completion
2026-10-07
Completion
2026-10-07

Countries

  • France

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 NCT03993912 on ClinicalTrials.gov