A Study of Daratumumab Plus Lenalidomide Versus Lenalidomide Alone as Maintenance Treatment in Participants With Newly Diagnosed Multiple Myeloma Who Are Minimal Residual Disease Positive After Frontline Autologous Stem Cell Transplant

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

April 26, 2019

Primary Completion Date

April 4, 2024

Study Completion Date

May 29, 2026

Conditions
Multiple Myeloma
Interventions
DRUG

Daratumumab

Daratumumab 1800 mg will be administered by SC injection weekly during Cycles 1 and 2, every 2 weeks during Cycles 3 through 6, and every 4 weeks from Cycle 7 onward until confirmed progressive disease (PD), unacceptable toxicity, or until end of study treatment for a maximum of 36 cycles.

DRUG

Lenalidomide

Lenalidomide 10 mg will be administered orally from Day 1 to Day 28 (continuously) of each 28-day cycle until confirmed PD, unacceptable toxicity, or until end of study treatment for a maximum of 36 cycles. After 3 cycles of maintenance therapy, if well tolerated, the lenalidomide dose may be increased to 15 mg daily, at the discretion of the investigator.

Trial Locations (73)

10029

Icahn School of Medicine at Mount Sinai, New York

10032

Columbia University Medical Center, New York

10467

Montefiore Einstein Center for Cancer Care, The Bronx

11042

Northwell Health, Lake Success

11501

NYU Winthrop, Mineola

12206

New York Oncology Hematology, Albany

13210

SUNY Upstate Medical University, Syracuse

15224

West Penn Hospital, Pittsburgh

15323

University Of Pittsburgh Medical Center UPMC Hillman Cancer Center, Pittsburgh

19111

Fox Chase Cancer Center, Philadelphia

19611

Reading Hospital/McGlinn Cancer Institute, West Reading

20007

MedStar Georgetown University Hospital, Washington D.C.

21201

University of Maryland Greenebaum Cancer Center, Baltimore

22031

Virginia Cancer Specialists, Fairfax

22903

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

23502

Virginia Oncology Associates, Norfolk

27103

Novant Oncology Research Institute, Winston-Salem

27157

Wake Forest Health Sciences, Winston-Salem

28204

Levine Cancer Institute, Carolinas HealthCare System, Charlotte

Novant Health, Charlotte

29303

Spartanburg Regional Health Services, Spartanburg

30607

University Cancer And Blood Center LLC, Athens

32256

Cancer Specialists of North Florida, Jacksonville

33136

University of Miami Sylvester Cancer Center, Miami

33176

Miami Cancer Institute, Miami

33331

Cleveland Clinic Florida, Weston

33612

Moffitt Cancer Center, Tampa

35294

University of Alabama Birmingham, Birmingham

37203

Tennessee Oncology, Nashville

37404

Tennessee Oncology, Chattanooga

38120

Baptist Cancer Center, Memphis

39216

University of Mississippi Medical Center, Jackson

40207

Norton Cancer Institute, Louisville

45236

Oncology Hematology Care, Cincinnati

46804

Fort Wayne Medical Oncology and Hematology American Oncology Partners, Fort Wayne

49503

Cancer And Hematology Centers of Western Michigan PC, Grand Rapids

60099

Cancer Treatment Centers of America, Zion

60714

Illinois Cancer Specialists, Niles

64132

HCA MidAmerica Division Inc Research Medical Center, Kansas City

66160

University of Kansas Cancer Center, Westwood

70121

Ochsner Clinic Foundation, New Orleans

75235

UT Southwestern Medical Center, Dallas

75246

Texas Oncology P A, Dallas

75702

Texas Oncology P A, Tyler

77030

MD Anderson Cancer Center, Houston

78229

Mays Cancer Center (UT Health San Antonio), San Antonio

78745

Texas Oncology-Central South, Austin

80218

Colorado Blood Cancer Institute, Denver

Rocky Mountain Cancer Centers, Denver

80528

University of Colorado Health, Fort Collins

84112

Huntsman Cancer Institute, Salt Lake City

85308

Arizona Oncology Associates, PC - HAL, Glendale

85338

Cancer Treatment Center of America Phoenix, Goodyear

90095

UCLA David Geffen School of Medicine, Los Angeles

92093

University of California San Diego (UCSD) - The Rebecca and John Moores Cancer Center, La Jolla

94143

University of California San Francisco, San Francisco

97227

Northwest Cancer Specialists PC, Portland

97239

Oregon Health And Science University, Portland

98108

VA Puget Sound Healthcare System, Seattle

98109

University of Washington, Seattle

99216

Cancer Care Northwest, Spokane

06510

Yale University Medical Center, New Haven

46237-8601

Franciscan Health, Indianapolis

02215

Beth Israel Deaconess Medical Center, Boston

48202-2608

Henry Ford Cancer Institute, Detroit

07932

Summit Medical Group/MD Anderson Cancer Center, Florham Park

08901-1914

Rutgers, The State Univ of NJ-Robert Wood Johnson Medical School-The Cancer Institute of NJ (CINJ), New Brunswick

27599-7305

University of North Carolina, Chapel Hill

19107-4215

Thomas Jefferson University, Philadelphia

29615-4816

Greenville Health System Cancer Institute, Greenville

M5G 1X6

Princess Margaret Hospital, Toronto

H4A 3J1

McGill University Health Centre, Montreal

G1R 2J6

CHU de Quebec Universite Laval Hopital de l Enfant Jesus, Québec

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY