Expression-linked and R-ISS-adapted Stratification for First Line Therapy in Multiple Myeloma Patients

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

February 3, 2023

Primary Completion Date

August 31, 2027

Study Completion Date

October 31, 2028

Conditions
Newly Diagnosed Multiple Myeloma
Interventions
DRUG

Isatuximab

i.v. Induction Phase (Arm A and B): Induction Cycle 1 10 mg/kg D 1, 8, 15, 22, 29. Induction Cycle 2-3 10 mg/kg D 1, 15, 29 Consolidation Phase (Arm B): Consolidation Cycle 1-3 10 mg/kg D 1, 15, 29 Maintenance Phase (Arm A and B): Maintenance Cycle 1 and subsequent cycles 10 mg/kg D 1, 15, 29

DRUG

Lenalidomide

hard capsule for oral use. Induction Phase (Arm A and B): Induction Cycle 1-3 25 mg D1-14, 20-35. Consolidation Phase (Arm B): Consolidation Cycle 1-3 25 mg D1-14, 20-35. Maintenance Phase (Arm A and B): Maintenance Cycle 1-2 10 mg D1-28. Maintenance Cycle 3 and subsequent cycles 15 mg D1-28 if tolerable

DRUG

Bortezomib

s.c. injection. Induction Phase (Arm A and B): Induction Cycle 1-3 1,3 mg/m² D1, 4, 8, 11, 22, 25, 29, 32. Consolidation Phase (Arm B): Consolidation Cycle 1-3 1,3 mg/m² D1, 4, 8, 11, 22, 25, 29, 32

DRUG

Dexamethasone

orally and i.v. Induction Phase (Arm A and B): Induction Cycle 1 20 mg p.o. D 1-2, 4-5, 8-9, 11-12, 15; 22-23, 25-26, 29-30, 32-33; 20 mg i.v. D1, 8, 15, 22 and 29. Induction Cycles 2 and 3 20 mg p.o. D 1-2, 4-5, 8-9, 11-12, 15; 22-23, 25-26, 29-30, 32-33; 20 mg i.v. D1, 15 and 29. Consolidation Phase (Arm B): Consolidation Cycle 1-3 20 mg p.o. on D 1-2, 4-5, 8-9, 11-12, 15; 22-23, 25-26, 29-30, 32-33; 20 mg i.v. on D1, 15 and 29

OTHER

autologous stem cell transplant

autologous stem cell transplant

Trial Locations (6)

12200

RECRUITING

Heloisklinikum Berlin Buch GmbH, Berlin

20246

RECRUITING

Universitätsklinikum Hamburg Eppendorf (UKE), Hamburg

23538

RECRUITING

Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Lübeck

33604

RECRUITING

Klinikum Bielefeld - Onkologie, Hämatologie, Paliativmedizin, Bielefeld

48149

RECRUITING

Universitätsklinikum Münster, Münster

97080

NOT_YET_RECRUITING

Universitätsklinikum Würzburg, Würzburg

All Listed Sponsors
lead

University Hopsital Schleswig Holstein Campus Lübeck

OTHER