Multiple Myeloma Support + Trials

What's the purpose of this trial?

The purpose of this clinical trial is to compare the use of an investigational medicine and lenalidomide vs. lenalidomide alone as maintenance in patients with newly diagnosed multiple myeloma who are minimal residual disease positive after an autologous stem cell transplant.

This trial is currently open and accepting patients.

What's being studied?

Daratumumab is a type of cancer drug called a monoclonal antibody. Daratumumab attaches to a protein called CD38, which is present in high numbers on the surface of multiple myeloma cells, as well as on certain other types of cells, such as red blood cells.
Lenalidomide is an immunomodulatory drug that may help the immune system kill cancer cells. It may also prevent the growth of new blood vessels that tumors need to grow.

What will happen during the trial?

Participants in this study will be randomly assigned to one of two groups (also called arms). Participants in Arm A will receive daratumumab and lenalidomide, while participants in Arm B will receive lenalidomide alone.

Participants in either arm will receive their therapies in 28 day cycles, and may receive up to 36 cycles as long as their myeloma doesn’t get worse or they don’t experience bad side effects.

ARM A

Participants will receive daratumumab by a subcutaneous injection weekly during cycles 1 and 2, every two weeks during cycles 3-6, and every four weeks from cycle 7 onwards.
Participants will receive lenalidomide by mouth daily. After three cycles, if lenalidomide is well tolerated, the dose may be increased at the discretion at the study doctor.

ARM B

Participants will receive lenalidomide by mouth daily. After three cycles, if lenalidomide is well tolerated, the dose may be increased at the discretion at the study doctor.

See if you qualify

Additional Trial Information

Phase 3

Enrollment: 214 patients (estimated)

Need Help?

Interested in joining or learning more about this trial?

(888) 828-2206

I'm Interested

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required. Create your account or call us today for help (888) 828-2206.

Patient must have newly diagnosed multiple myeloma
Patient must have received at least 4 cycles of induction therapy
Patient must have had an autologous stem cell transplant within one year of beginning of induction therapy
Patient must have minimal residual disease (MRD) as defined by Adaptive Biotechnologies’ NGS-based (MRD) assay
Patient must have not had prior treatment with daratumumab or any other anti-CD-38 therapies
Patient must not have had radiation therapy within 14 days of joining the study
Patient must not have evidence of central nervous system myeloma involvement

View Additional Criteria

Inclusion Criteria:

Have newly diagnosed multiple myeloma with a history of 4 to 8 total cycles of induction with or without consolidation therapy and have received high-dose therapy (HDT) and autologous stem cell transplantation (ASCT): (a) for participants who have not received consolidation therapy, the participant must be within 180 days post-transplant at the time of randomization; and (b) for participants treated with consolidation therapy, the participant must be within 90 days of the last dose of consolidation therapy at the time of randomization
Must have a very good partial response (VGPR) or better response assessed per International Myeloma Working Group (IMWG) 2016 criteria at the time of randomization
Have archived bone marrow samples collected before induction treatment (that is, at diagnosis) or before transplant (for example, at the end of induction) or have existing results on the index multiple myeloma clone based on Adaptive Biotechnologies' next generation sequencing (NGS)-based minimal residual disease (MRD) assay. Archived bone marrow samples will be used for calibration of myeloma clonal cells to facilitate assessment of primary end point by NGS. If an existing result on index myeloma clone is available from Adaptive Biotechnologies' NGS-based MRD assay, as part of institutional procedures, an archived bone marrow sample is not required as long as Adaptive Biotechnologies is able to retrieve historical results on the index myeloma clone form the clinical database. Any one of the following archived samples are required: (a) Greater than 1 milliliter (mL) viable frozen bone marrow aspirated aliquot (preferred) collected in an ethylenediaminetetra-acetic acid (EDTA) tube, frozen, and stored at a temperature of −80 centigrade (°C), or; (b) Non-decalcified diagnostic bone marrow aspirate clot sections (block or slides) for MRD assessment: (i) A formalin fixed paraffin embedded (FFPE) block of bone marrow aspirate clot, or 5 slides, 5 micrometer each, of non-decalcified bone marrow, or (ii) 5 slides, bone marrow aspirate smear
Must have residual disease as defined by detectable MRD (Adaptive Biotechnologies' NGS based MRD assay)
Must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2

Exclusion Criteria:

A history of malignancy (other than multiple myeloma) unless all treatment of that malignancy was completed at least 2 years before consent and the participant has no evidence of disease before the of date of randomization. Exceptions are squamous and basal cell carcinomas of the skin, carcinoma in situ of the cervix or breast, or other non-invasive lesion that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years
Have had prior treatment/therapy with: (a) Daratumumab or any other anti-cluster of differentiation 38 (CD38) therapies, (b) Focal radiation therapy within 14 days prior to randomization with the exception of palliative radiotherapy for symptomatic management but not on measurable extramedullary plasmacytoma. Radiotherapy within 14 days prior to randomization on measurable extramedullary plasmacytoma is not permitted even in the setting of palliation for symptomatic management, or (c) Plasmapheresis within 28 days of randomization
Be exhibiting clinical signs of meningeal or central nervous system involvement due to multiple myeloma
Have known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) less than (<) 50 percent (%) of predicted normal
Have known moderate or severe persistent asthma within the past 2 years or current uncontrolled asthma of any classification
Have any of the following: (a) Known history of seropositivity for human immunodeficiency virus (HIV); (b) Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]. Participants with resolved infection (that is, participants who are HBsAg negative but positive for antibodies to hepatitis B core antigen [anti-HBc] and/or antibodies to hepatitis B surface antigen [anti-HBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) DNA levels. Those who are PCR positive will be excluded. EXCEPTION: Participants with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR; (c) Seropositive for hepatitis C (anti-hepatitis C virus [HCV] antibody positive or HCV-RNA quantitation positive), except in the setting of a sustained virologic response, defined as aviremia at least 12 weeks after completion of antiviral therapy)

Alabama

UAB Comprehensive Cancer Center University of Alabama at Birmingham
Birmingham, AL

Open and Accepting

Arizona

Arizona Oncology Associates
Glendale, AZ

Open and Accepting

California

UCSF Helen Diller Comprehensive Cancer Center University of California San Francisco
San Francisco, CA

Open and Accepting

Moores Cancer Center UC San Diego Health
La Jolla, CA

Open and Accepting

UCLA Jonsson Comprehensive Cancer Center University of California Los Angeles
Los Angeles, CA

Open and Accepting

Colorado

Colorado Blood Cancer Institute Presbyterian/St. Luke's Medical Center (HealthONE)
Denver, CO

Open and Accepting

Rocky Mountain Cancer Centers Denver - Midtown
Denver, CO

Open and Accepting

University of Colorado Health Poudre Valley Hospital
Fort Collins, CO

Open and Accepting

Connecticut

Yale Cancer Center Smilow Cancer Hospital at Yale-New Haven
New Haven, CT

Open and Accepting

Florida

Cancer Specialists of North Florida Southpoint
Jacksonville, FL

Open and Accepting

Miami Cancer Institute Baptist Health South Florida
Miami, FL

Open and Accepting

Moffitt Cancer Center Magnolia Campus
Tampa, FL

Open and Accepting

Cleveland Clinic Florida
Weston, FL

Open and Accepting

Illinois

Illinois Cancer Specialists
Niles, IL

Open and Accepting

Cancer Treatment Centers of America Midwestern Regional Medical Center
Zion, IL

Not Yet Accepting

Indiana

Fort Wayne Medical Oncology and Hematology Fort Wayne North Office
Fort Wayne, IN

Open and Accepting

Blood and Marrow Transplantation Franciscan Health
Indianapolis, IN

Open and Accepting

Kansas

University of Kansas Cancer Center
Kansas City, KS

Open and Accepting

Louisiana

Ochsner Medical Center
Jefferson, LA

Open and Accepting

Maryland

University of Maryland Medical Center Marlene and Stewart Greenebaum Comprehensive Cancer Center
Baltimore, MD

Open and Accepting

Massachusetts

Beth Israel Deaconess Medical Center
Boston, MA

Open and Accepting

Michigan

Henry Ford Hospital
Detroit, MI

Open and Accepting

Cancer and Hematology Centers of Western Michigan (Grand Rapids)
Grand Rapids, MI

Open and Accepting

Mississippi

University of Mississippi Medical Center
Jackson, MS

Open and Accepting

Missouri

Sarah Cannon Cancer Center at Research Medical Center
Kansas City, MO

Open and Accepting

New Jersey

Summit Medical Group MD Anderson Cancer Center
Florham Park, NJ

Open and Accepting

Rutgers Cancer Institute of New Jersey Rutgers, The State University of New Jersey
New Brunswick, NJ

Open and Accepting

New York

New York Oncology Hematology
Albany, NY

Open and Accepting

Montefiore Medical Center
Bronx, NY

Open and Accepting

Northwell Health Monter Cancer Center
Lake Success, NY

Open and Accepting

NYU Winthrop Hospital
Mineola, NY

Open and Accepting

Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
New York, NY

Open and Accepting

Mount Sinai Hospital Tisch Cancer Institute
New York, NY

Open and Accepting

SUNY Upstate Medical University State University of New York
Syracuse, NY

Open and Accepting

North Carolina

UNC Lineberger Comprehensive Cancer Center University of North Carolina
Chapel Hill, NC

Open and Accepting

Wake Forest Baptist Comprehensive Cancer Center Wake Forest School of Medicine
Winston-Salem, NC

Open and Accepting

Levine Cancer Institute Atrium Health
Charlotte, NC

Open and Accepting

Presbyterian Hospital Novant Health
Charlotte, NC

Open and Accepting

Forsyth Medical Center Novant Health
Winston-Salem, NC

Open and Accepting

Ohio

Oncology Hematology Care Inc. (Mercy West)
Cincinnati, OH

Open and Accepting

Oregon

Oregon Health and Science University (OHSU) Knight Cancer Institute
Portland, OR

Open and Accepting

Northwest Cancer Specialists, PC
Tualatin, OR

Open and Accepting

Pennsylvania

Sidney Kimmel Cancer Center Thomas Jefferson University
Philadelphia, PA

Open and Accepting

Fox Chase Cancer Center Temple Health
Philadelphia, PA

Open and Accepting

Hillman Cancer Center University of Pittsburgh Medical Center (UPMC)
Pittsburgh, PA

Open and Accepting

Allegheny Health Network (West Penn)
Pittsburgh, PA

Open and Accepting

Reading Hospital and Medical Center
Reading, PA

Open and Accepting

South Carolina

Prisma Health Greenville Memorial Hospital
Greenville, SC

Open and Accepting

Prisma Health Spartanburg
Spartanburg, SC

Open and Accepting

Tennessee

Tennessee Oncology Memorial Plaza
Chattanooga, TN

Open and Accepting

Baptist Cancer Center Memphis
Mempis, TN

Open and Accepting

Sarah Cannon TriStar Centennial Medical Center
Nashville, TN

Open and Accepting

Texas

Texas Oncology Austin Midtown
Austin, TX

Open and Accepting

The University of Texas Southwestern Medical Center Harold C. Simmons Comprehensive Cancer Center
Dallas, TX

Open and Accepting

Texas Oncology (Dallas)
Dallas, TX

Open and Accepting

MD Anderson Cancer Center The University of Texas
Houston, TX

Open and Accepting

UT Health Science Center Cancer Therapy and Research Center
San Antonio, TX

Not Yet Accepting

Texas Oncology
Tyler, TX

Open and Accepting

Utah

Huntsman Cancer Institute University of Utah
Salt Lake City, UT

Open and Accepting

Virginia

Virginia Cancer Specialists
Fairfax, VA

Open and Accepting

UVA Cancer Center University of Virginia Health System
Charlottesville, VA

Open and Accepting

Virginia Oncology Associates Norfolk (Lake Wright)
Norfolk, VA

Open and Accepting

Washington

University of Washington School of Medicine
Seattle, WA

Open and Accepting

Cancer Care Northwest (Sherman)
Spokane, WA

Open and Accepting

Washington, D.C.

MedStar Georgetown University Hospital
Washington, DC

Open and Accepting

What's the purpose of this trial?

What's being studied?

What will happen during the trial?

Additional Trial Information

You may be able to join this trial if you:

Trial Locations

All Trial Locations

Alabama

UAB Comprehensive Cancer Center University of Alabama at Birmingham Birmingham, AL

Open and Accepting

Arizona

Arizona Oncology Associates Glendale, AZ

Open and Accepting

California

UCSF Helen Diller Comprehensive Cancer Center University of California San Francisco San Francisco, CA

Open and Accepting

Moores Cancer Center UC San Diego Health La Jolla, CA

Open and Accepting

UCLA Jonsson Comprehensive Cancer Center University of California Los Angeles Los Angeles, CA

Open and Accepting

Colorado

Colorado Blood Cancer Institute Presbyterian/St. Luke's Medical Center (HealthONE) Denver, CO

Open and Accepting

Rocky Mountain Cancer Centers Denver - Midtown Denver, CO

Open and Accepting

University of Colorado Health Poudre Valley Hospital Fort Collins, CO

Open and Accepting

Connecticut

Yale Cancer Center Smilow Cancer Hospital at Yale-New Haven New Haven, CT

Open and Accepting

Florida

Cancer Specialists of North Florida Southpoint Jacksonville, FL

Open and Accepting

Miami Cancer Institute Baptist Health South Florida Miami, FL

Open and Accepting

Moffitt Cancer Center Magnolia Campus Tampa, FL

Open and Accepting

Cleveland Clinic Florida Weston, FL

Open and Accepting

Illinois

Illinois Cancer Specialists Niles, IL

Open and Accepting

Cancer Treatment Centers of America Midwestern Regional Medical Center Zion, IL

Not Yet Accepting

Indiana

Fort Wayne Medical Oncology and Hematology Fort Wayne North Office Fort Wayne, IN

Open and Accepting

Blood and Marrow Transplantation Franciscan Health Indianapolis, IN

Open and Accepting

Kansas

University of Kansas Cancer Center Kansas City, KS

Open and Accepting

Louisiana

Ochsner Medical Center Jefferson, LA

Open and Accepting

Maryland

University of Maryland Medical Center Marlene and Stewart Greenebaum Comprehensive Cancer Center Baltimore, MD

Open and Accepting

Massachusetts

Beth Israel Deaconess Medical Center Boston, MA

Open and Accepting

Michigan

Henry Ford Hospital Detroit, MI

Open and Accepting

Cancer and Hematology Centers of Western Michigan (Grand Rapids) Grand Rapids, MI

Open and Accepting

Mississippi

University of Mississippi Medical Center Jackson, MS

Open and Accepting

Missouri

Sarah Cannon Cancer Center at Research Medical Center Kansas City, MO

Open and Accepting

New Jersey

Summit Medical Group MD Anderson Cancer Center Florham Park, NJ

Open and Accepting

Rutgers Cancer Institute of New Jersey Rutgers, The State University of New Jersey New Brunswick, NJ

Open and Accepting

New York

New York Oncology Hematology Albany, NY

Open and Accepting

UAB Comprehensive Cancer Center University of Alabama at Birmingham
Birmingham, AL

Arizona Oncology Associates
Glendale, AZ

UCSF Helen Diller Comprehensive Cancer Center University of California San Francisco
San Francisco, CA

Moores Cancer Center UC San Diego Health
La Jolla, CA

UCLA Jonsson Comprehensive Cancer Center University of California Los Angeles
Los Angeles, CA

Colorado Blood Cancer Institute Presbyterian/St. Luke's Medical Center (HealthONE)
Denver, CO

Rocky Mountain Cancer Centers Denver - Midtown
Denver, CO

University of Colorado Health Poudre Valley Hospital
Fort Collins, CO

Yale Cancer Center Smilow Cancer Hospital at Yale-New Haven
New Haven, CT

Cancer Specialists of North Florida Southpoint
Jacksonville, FL

Miami Cancer Institute Baptist Health South Florida
Miami, FL

Moffitt Cancer Center Magnolia Campus
Tampa, FL

Cleveland Clinic Florida
Weston, FL

Illinois Cancer Specialists
Niles, IL

Cancer Treatment Centers of America Midwestern Regional Medical Center
Zion, IL

Fort Wayne Medical Oncology and Hematology Fort Wayne North Office
Fort Wayne, IN

Blood and Marrow Transplantation Franciscan Health
Indianapolis, IN

University of Kansas Cancer Center
Kansas City, KS

Ochsner Medical Center
Jefferson, LA

University of Maryland Medical Center Marlene and Stewart Greenebaum Comprehensive Cancer Center
Baltimore, MD

Beth Israel Deaconess Medical Center
Boston, MA

Henry Ford Hospital
Detroit, MI

Cancer and Hematology Centers of Western Michigan (Grand Rapids)
Grand Rapids, MI

University of Mississippi Medical Center
Jackson, MS

Sarah Cannon Cancer Center at Research Medical Center
Kansas City, MO

Summit Medical Group MD Anderson Cancer Center
Florham Park, NJ

Rutgers Cancer Institute of New Jersey Rutgers, The State University of New Jersey
New Brunswick, NJ

New York Oncology Hematology
Albany, NY

Montefiore Medical Center
Bronx, NY

Northwell Health Monter Cancer Center
Lake Success, NY

NYU Winthrop Hospital
Mineola, NY

Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
New York, NY

Mount Sinai Hospital Tisch Cancer Institute
New York, NY

SUNY Upstate Medical University State University of New York
Syracuse, NY

UNC Lineberger Comprehensive Cancer Center University of North Carolina
Chapel Hill, NC

Wake Forest Baptist Comprehensive Cancer Center Wake Forest School of Medicine
Winston-Salem, NC

Levine Cancer Institute Atrium Health
Charlotte, NC

Presbyterian Hospital Novant Health
Charlotte, NC

Forsyth Medical Center Novant Health
Winston-Salem, NC

Oncology Hematology Care Inc. (Mercy West)
Cincinnati, OH

Oregon Health and Science University (OHSU) Knight Cancer Institute
Portland, OR

Northwest Cancer Specialists, PC
Tualatin, OR

Sidney Kimmel Cancer Center Thomas Jefferson University
Philadelphia, PA

Fox Chase Cancer Center Temple Health
Philadelphia, PA

Hillman Cancer Center University of Pittsburgh Medical Center (UPMC)
Pittsburgh, PA

Allegheny Health Network (West Penn)
Pittsburgh, PA

Reading Hospital and Medical Center
Reading, PA

Prisma Health Greenville Memorial Hospital
Greenville, SC

Prisma Health Spartanburg
Spartanburg, SC

Tennessee Oncology Memorial Plaza
Chattanooga, TN

Baptist Cancer Center Memphis
Mempis, TN

Sarah Cannon TriStar Centennial Medical Center
Nashville, TN

Texas Oncology Austin Midtown
Austin, TX

The University of Texas Southwestern Medical Center Harold C. Simmons Comprehensive Cancer Center
Dallas, TX

Texas Oncology (Dallas)
Dallas, TX

MD Anderson Cancer Center The University of Texas
Houston, TX

UT Health Science Center Cancer Therapy and Research Center
San Antonio, TX

Texas Oncology
Tyler, TX