A Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens

PHASE2CompletedINTERVENTIONAL
Enrollment

265

Participants

Timeline

Start Date

April 26, 2018

Primary Completion Date

August 12, 2020

Study Completion Date

April 18, 2024

Conditions
Multiple Myeloma
Interventions
DRUG

Daratumumab

Daratumumab will be administered at a dose of 1800 mg by SC injection in Cycles 1 to 4 in D-VRd cohort and until documented progression of disease, unacceptable toxicity, or end of study for D-VMP, D-Rd and D-Kd cohorts.

DRUG

Bortezomib

Bortezomib will be administered as 1.3 mg/m\^2 SC injection in Cycles 1 to 4 in D-VRd cohort and in Cycles 1 to 9 in D-VMP cohort.

DRUG

Lenalidomide

Lenalidomide will be administered as 25 mg capsule orally in Cycles 1 to 4 in D-VRd cohort and in all Cycles until documented progression of disease, unacceptable toxicity, or end of study in D-Rd cohort.

DRUG

Dexamethasone

Dexamethasone will be administered as 20 mg orally or intravenously in Cycles 1 to 4 in D-VRd cohort; 40 mg orally or intravenously in all cycles and thereafter until documented progression of disease, unacceptable toxicity, or end of study in D-Rd and D-Kd cohort.

DRUG

Melphalan

Melphalan will be administered as 9 mg/m\^2 orally in Cycles 1 to 9.

DRUG

Prednisone

Prednisone will be administered as 60 mg/m\^2 orally in cycles 1 to 9.

DRUG

Carfilzomib

Carfilzomib will be administered as 20 mg/m\^2 IV on Day 1 of Cycle 1 only then 70 mg/m\^2 IV on Days 8 and 15 of Cycle 1 and Days 1, 8 and 15 of Cycle 2 and thereafter until documented progression of disease, unacceptable toxicity, or end of study in D-Kd cohort.

Trial Locations (64)

8035

Hosp Univ Vall D Hebron, Barcelona

10029

Mt. Sinai School of Medicine, New York

11501

NYU Winthrop, Mineola

20246

Universitaetsklinikum Hamburg Eppendorf, Hamburg

22100

Galilee Medical Center, Nahariya

22763

Asklepios Klinik Altona, Hamburg

22903

University of Virginia Cancer Center - Emily Couric Clinical Cancer Center - Women's Oncology Clinic, Charlottesville

27157

Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer Center, Winston-Salem

28007

Hosp. Gral. Univ. Gregorio Maranon, Madrid

28027

Clinica Univ. de Navarra, Madrid

28034

Hosp. Univ. Ramon Y Cajal, Madrid

28041

Hosp. Univ. 12 de Octubre, Madrid

31008

Clinica Univ. de Navarra, Pamplona

31096

Rambam Medical Center, Haifa

32224

Mayo Clinic in Florida, Jacksonville

32806

UF Health Cancer Center at Orlando Health, Orlando

33604

CHU de Bordeaux - Hospital Haut-Leveque, Pessac

37007

Hosp Clinico Univ de Salamanca, Salamanca

37044

CHU Bretonneau, Tours

44093

CHU de Nantes hotel Dieu, Nantes

46017

Hosp. Univ. Dr. Peset, Valencia

48075

Providence Cancer Center, Southfield

48201

Karmonos Cancer Institute, Detroit

52621

Sheba Medical Center, Ramat Gan

54511

CHU Nancy Brabois, Vandœuvre-lès-Nancy

57105

Avera Medical Group - Oncology & Hematology, Sioux Falls

59101

Billings Clinic, Billings

64239

Tel Aviv Sourasky Medical Center, Tel Aviv

68130

Nebraska Cancer Specialists, Omaha

68506

Nebraska Hematology and Oncology, Lincoln

68510

Southeast Nebraska Cancer Center, Lincoln

69120

Universitaetsklinikum Heidelberg, Heidelberg

69495

Centre hospitalier Lyon-Sud, Pierre-Bénite

70852

Fakultni Nemocnice Ostrava, Ostrava

72076

Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,, Tübingen

84121

Utah Cancer Specialists, Salt Lake City

87401

San Juan Oncology Associates, Farmington

3436212

Carmel Medical Center, Haifa

9112001

Hadassah Medical Center, Jerusalem

06489-3237

Cancer Center of Central Connecticut - Southington, Southington

59062 000

Liga Norte Riograndense Contra O Cancer, Natal

99010-090

Associacao Hospitalar Beneficente Sao Vicente de Paulo - Hospital Sao Vicente de Paulo, Passo Fundo

20230 130

Ministerio da Saude Instituto Nacional do Cancer, Rio de Janeiro

01455 010

Clinica Sao Germano, São Paulo

04037-002

SPDM - Associacao Paulista para o Desenvolvimento da Medicina - Hospital Sao Paulo, São Paulo

04039-004

Instituto de Assistencia Medica ao Servidor Publico Estadual IAMSPE, São Paulo

625 00

Fakultni nemocnice Brno, Brno

500 05

Fakultni nemocnice Hradec Kralove, Hradec Králové

128 08

Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie, Prague

09113

Klinikum Chemnitz gGmbH, Chemnitz

920 8641

Kanazawa University Hospital, Kanazawa

790-8524

Matsuyama Red Cross Hospital, Matsuyama

467 8602

Nagoya City University Hospital, Nagoya

150-8935

Japanese Red Cross Medical Center, Shibuya City

08916

Inst. Cat. D'Oncologia-Badalona, Badalona

08036

Hosp Clinic de Barcelona, Barcelona

08908

Inst. Cat. Doncologia-H Duran I Reynals, Barcelona

07198

Hosp. Son Llatzer, Mallorca

B9 5SS

Heart of England NHS Foundation Trust, Birmingham

BH7 7DW

Royal Bournemouth Hospital, Bournemouth

CT1 3NG

Kent and Canterbury Hospital, Canterbury

M13 9WL

Manchester Royal Infirmary, Manchester

PL6 8DH

Derriford Hospital, Plymouth

ST4 6QG

Royal Stoke University Hospital, Stoke-on-Trent

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT03412565 - A Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens | Biotech Hunter | Biotech Hunter