NCT04891809 - Isatuximab in Combination With Rd Compared to Rd in Elderly Patients (Aged ≥70 Years) With NDMM | Biotech Hunter

Enrollment

198

Participants

Timeline

Start Date

October 20, 2021

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2028

Conditions

Newly Diagnosed Multiple Myeloma

Interventions

DRUG

Isatuximab-Irfc 20 MG/ML [Sarclisa]

Induction: 10mg/kg on day 1,8,15,22 in cycle 1, subsequently on day 1, 15; every 28 days (q28 days) Maintenance: 10mg/kg, day1, q28 days until progression or intolerance but for a maximum of 24 cycles from start of maintenance

DRUG

Lenalidomide

"Induction: 25mg\*, day 1-21, every 28 days (q28 days); Maintenance: 5-10mg, day 1-21, q28 days (according to individual tolerance) until progression or intolerance but for a maximum of 24 cycles from start of maintenance~\*) for patients with moderate renal impairment (30≤ GFR (MDRD formula) \< 50 mL/min) starting dose is 10 mg"

DRUG

Dexamethasone Oral

"Induction:~Patients aged \<75 years: 40mg, once weekly; Patients aged ≥75 years: 20mg, once weekly"

Trial Locations (14)

1060

Krankenhaus d. Barmh. Schwestern Wien, 1. Med. Abteilung, Onkologie und Hämatologie, Vienna

1140

Hanusch Krankenhaus der Österreichischen Gesundheitskasse, 3. Med. Abteilung, Vienna

1160

Klinik Ottakring, 1.Med.Abt., Zentrum f. Onkologie, Haematologie und Palliativmedizin, Vienna

3100

Univ.-Klinikum St. Pölten, Innere Medizin 1, Sankt Pölten

3500

Univ.Klinikum Krems, Klin. Abt. f. Innere Medizin 2, Mitterweng

5020

PMU Salzburg: Universitätsklinik für Innere Medizin III, Salzburg

6330

Bezirkskrankenhaus Kufstein, Innere Medizin, Interne II u. onkologische Tagesklinik, Kufstein

6511

Krankenhaus Zams, Innere Medizin, Internistische Onkologie-Haematologie, Zams

8700

LKH Hochsteiermark - Leoben, Abt. f. Innere Medizin, Haemato-Onkologie, Leoben

10676

"General Hospital of Athens Evangelismos, Hematology Clinic", Athens

11000

University Clinical Center of Serbia, Clinic for Hematology, Belgrade

11528

"General Hospital of Athens Alexandra, Plasma Cell Dyscrasias Unit", Athens

34000

University Clinical Center Kragujevac, Clinic for Hematology, Kragujevac

54639

"Anticancer Hospital of Thessaloniki Theageneio, Hematology", Thessaloniki