Who is sponsoring NCT03993912?

NCT03993912 is sponsored by University Hospital, Lille.

What drugs are being tested in NCT03993912?

Interventions in NCT03993912: Daratumumab SC in combination with Lenalidomide, Lenalidomide PO (25mg), Dexamethasone PO (20mg): days 1, 8, 15, 22 of each 28-day cycle, until progression.

What condition does NCT03993912 study?

NCT03993912 studies Multiple Myeloma.

Is NCT03993912 still recruiting?

NCT03993912 is currently active, enrolled. Last updated 7 April 2026.

Last reviewed 2026-04-07 · How we verify

NCT03993912: IFM2017_03

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Active, enrolled Phase 3 Last updated 7 April 2026

What this trial tests

Phase 3 trial testing Daratumumab SC in combination with Lenalidomide in Multiple Myeloma in 294 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

17 October 2019

Primary endpoint
7 October 2026

7 October 2026

Quick facts

Lead sponsor	University Hospital, Lille
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	294
Start date	17 October 2019
Primary completion	7 October 2026
Estimated completion	7 October 2026
Sites	23 locations across France

Drugs / interventions tested

Daratumumab SC in combination with Lenalidomide — full drug profile →
Lenalidomide PO (25mg) — full drug profile →
Dexamethasone PO (20mg): days 1, 8, 15, 22 of each 28-day cycle, until progression — full drug profile →

Conditions studied

Multiple Myeloma — all drugs for Multiple Myeloma →

Sponsor

University Hospital, Lille

Who can join

65 and older, any sex, with Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Minimal Residual Disease in Myeloma: Application for Clinical Care and New Drug Registration.
Anderson KC, Auclair D, Adam SJ, Agarwal A, et al · · 2021 · cited 44× · PMID 34321279 · DOI 10.1158/1078-0432.ccr-21-1059
How I treat multiple myeloma in geriatric patients.
Facon T, Leleu X, Manier S. · · 2024 · cited 43× · PMID 36693134 · DOI 10.1182/blood.2022017635
Daratumumab for the Management of Newly Diagnosed and Relapsed/Refractory Multiple Myeloma: Current and Emerging Treatments.
Offidani M, Corvatta L, Morè S, Nappi D, et al · · 2020 · cited 39× · PMID 33680948 · DOI 10.3389/fonc.2020.624661
Daratumumab in untreated newly diagnosed multiple myeloma.
Abdallah N, Kumar SK. · · 2019 · cited 36× · PMID 31903177 · DOI 10.1177/2040620719894871
30 Years of Improved Survival in Non-Transplant-Eligible Newly Diagnosed Multiple Myeloma.
Chacon A, Leleu X, Bobin A. · · 2023 · cited 13× · PMID 37046589 · DOI 10.3390/cancers15071929
Diagnostic and Therapeutic Challenges in the Management of Intermediate and Frail Elderly Multiple Myeloma Patients.
Bonello F, Boccadoro M, Larocca A. · · 2020 · cited 13× · PMID 33114320 · DOI 10.3390/cancers12113106
Immunotherapy of Multiple Myeloma: Promise and Challenges.
Abramson HN. · · 2021 · cited 12× · PMID 34527606 · DOI 10.2147/itt.s306103
The Role of Monoclonal Antibodies in the First-Line Treatment of Transplant-Ineligible Patients with Newly Diagnosed Multiple Myeloma.
Bonello F, Grasso M, D'Agostino M, Celeghini I, et al · · 2020 · cited 11× · PMID 33383757 · DOI 10.3390/ph14010020

Verify or expand the search:

Other recruiting trials for Multiple Myeloma

Currently open trials in the same condition.

NCT07200102 — Selinexor Maintenance Post CAR-T Cell Therapy for Multiple Myeloma · Phase 1 · recruiting
NCT07340853 — CRISPR Delivered Anti-BCMA Car-T Therapy for Relapsed or Refractory Multiple Myeloma · Phase 1 · recruiting
NCT07454382 — A Study of Elranatamab and Cyclophosphamide in People With Multiple Myeloma · Phase 2 · recruiting
NCT07266441 — A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma · Phase 2 · recruiting
NCT07258511 — A Study Comparing JNJ-79635322 and an Anti-B-cell Maturation Antigen (BCMA)xCD3 Bispecific Antibody in Participants With · Phase 3 · recruiting

Other University Hospital, Lille trials

Trials by the same sponsor.

NCT07528664 — Assessement of a Test a Financial-incentive Program for Pregnant Women and Their Smoking Partners to Reduce Smoking Duri · NA · not yet recruiting
NCT07434739 — PAravertebral CaTheter Versus Epidural Analgesia in Totally Minimally Invasive Esophagectomies · NA · not yet recruiting
NCT06958224 — Theranostic Approach by Early Multigene Sequencing in Advanced Poor Prognosis Cancers · NA · not yet recruiting
NCT07408999 — Totally Versus Hybrid Minimally Invasive Esophagectomy for Esophageal Cancer · NA · not yet recruiting
NCT07492030 — Validation of the Use of the Arteriovenous Tension Difference in CO2 Under Hyperbaric Conditions · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03993912 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University Hospital, Lille
Last refreshed: 7 April 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03993912.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing