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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

294

Participants

Timeline

Start Date

October 17, 2019

Primary Completion Date

October 31, 2026

Study Completion Date

October 31, 2027

Conditions
Multiple Myeloma
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

Trial Locations (23)

33604

Hopital Haut-Leveque - Chu, Pessac

Unknown

Chru Jean Minjoz, Besançon

Ch Blois Simone Veil, Blois

Ch Fleyriat, Bourg-en-Bresse

Chru Brest Site Hopital Morvan, Brest

Chu de Caen Normandie, Caen

Hopital Prive Sevigne - Cesson, Cesson-Sévigné

Chu Dijon Bourgogne, Dijon

Chu de Grenoble, Grenoble

Gpe Hospitalier La Rochelle-Re-Aunis, La Rochelle

Ch Chartres Louis Pasteur-Le Coudray, Le Coudray

Hôpital Claude Huriez, CHU, Lille

Institut Paoli Calmettes, Marseille

Chi Mont de Marsan Et Pays Des Sources, Mont-de-Marsan

Chu Montpellier, Montpellier

Chu de Nantes Site Hotel Dieu Hme, Nantes

Chu de Nice Hopital de L'Archet, Nice

Centre Hospitalier de Perigueux, Périgueux

Chru Rennes Site Pontchaillou, Rennes

Centre Hospitalier de Saint Quentin, Saint-Quentin

Centre Hospitalier Saint-Malo, St-Malo

Oncopole Chu Toulouse, Toulouse

Chu de Tours, Tours

All Listed Sponsors
lead

University Hospital, Lille

OTHER

NCT03993912 - Compare Lenalidomide and Subcutaneous Daratumumab vs Lenalidomide and Dexamethasone in Frail Subjects With Previously Untreated Multiple Myeloma Who Are Ineligible for High Dose Therapy | Biotech Hunter | Biotech Hunter