A Study to Compare Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) in Participants With Newly Diagnosed Multiple Myeloma (MajesTEC-7) MAJESTEC-7

What's the purpose of this trial?

The purpose of this study is to compare the efficacy of teclistamab in combination with daratumumab and lenalidomide (Tec-DR) versus daratumumab, lenalidomide, dexamethasone (DRd).

This is an upcoming trial that has not yet started accepting patients.


What will happen during the trial?

This trial is anticipated to open to US patients in April 2023

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.

Inclusion Criteria:

  • Have a diagnosis of multiple myeloma according to the International Myeloma Working Group (IMWG) diagnostic criteria
  • Be newly diagnosed and not considered a candidate for high-dose chemotherapy with autologous stem cell transplant (ASCT) due to: ineligible due to advanced age OR; ineligible due to the presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with ASCT OR; deferral of high-dose chemotherapy with ASCT as initial treatment
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
  • A female participant must agree not to be pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 3 months after the last dose of study treatment
  • A male participant must agree not to plan to father a child while enrolled in this study or within 3 months after the last dose of study treatment

Exclusion Criteria:

  • Received a cumulative dose of systemic corticosteroids equivalent to greater than or equal to (>=) 20 milligrams (mg) of dexamethasone within 14 days before randomization
  • Had plasmapheresis within 28 days of randomization
  • Had a stroke, transient ischemic attack, or seizure within 6 months prior to randomization
  • Known allergies, hypersensitivity, or intolerance to teclistamab excipients
  • Known contraindications to the use of daratumumab or lenalidomide per local prescribing information

Additional Trial Information

Phase 3

Enrollment: 1,030 patients (estimated)

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Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

California

City of Hope Comprehensive Cancer Center Beckman Research Institute

Duarte, CA

Not Yet Accepting

Louisiana

Ochsner LSU Health Shreveport Ochsner Louisiana State University

Shreveport, LA

Not Yet Accepting

Massachusetts

Tufts Medical Center Cancer Center

Boston, MA

Not Yet Accepting

Michigan

Henry Ford Hospital

Detroit, MI

Not Yet Accepting

Ascension Providence Cancer Center (Foster Winter Drive)

Southfield, MI

Not Yet Accepting

New Jersey

Cooper University Hospital

Camden, NJ

Not Yet Accepting

New York

Memorial Sloan Kettering Cancer Center

New York, NY

Not Yet Accepting

North Carolina

Levine Cancer Institute Atrium Health

Charlotte, NC

Not Yet Accepting

Durham Veterans Affairs Medical Center

Durham, NC

Not Yet Accepting

Duke Cancer Center Duke University Medical Center

Durham, NC

Not Yet Accepting

Ohio

Oregon

Oregon Health and Science University (OHSU) Knight Cancer Institute

Portland, OR

Not Yet Accepting

Pennsylvania

Lehigh Valley Health Network Cancer Institute

Allentown, PA

Not Yet Accepting

Texas

MD Anderson Cancer Center The University of Texas

Houston, TX

Not Yet Accepting

Virginia

Fort Belvoir Community Hospital

Fort Belvoir, VA

Not Yet Accepting

Washington

Seattle Cancer Care Alliance SCCA

Seattle, WA

Not Yet Accepting

Washington, D.C.

MedStar Georgetown University Hospital

Washington, DC

Not Yet Accepting
Interested in this trial?
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