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 trial is currently open and 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 any prior therapy for multiple myeloma or smoldering myeloma other than a short course of corticosteroids (not to exceed total of 160 milligrams [mg] dexamethasone or equivalent). In addition, received a cumulative dose of systemic corticosteroids equivalent to greater than or equals to (>=) 20 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: 1,590 patients (estimated)

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Published Results

Safety results from the phase 3 MajesTEC-7 study in patients (pts) with transplant ineligible/not intended newly diagnosed multiple myeloma (NDMM)

May 29, 2024

As of Nov 27, 2023, 26 pts had received tec + DR (median, 11 cycles; range, 2–14) and 24 pts (92.3%) remained on tx. Median follow-up was 10.2 mo (range, 2–12). At baseline, median age was 72.5 yrs, 11.5% had an ECOG PS score of 2, and 15.4% had ≥1 soft-tissue plasmacytoma. 4 pts (15.4%) deferred transplant. Treatment-emergent AEs (TEAEs) occurred in 100% of pts (grade [gr] 3/4, 22 pts [84.6%]). Infections occurred in 25 pts (96.2%; gr 3/4, 8 pts [30.8%]). CRS occurred in 16 pts (61.5%; all gr 1). ICANS occurred in 1 pt (gr 1). Gr 3/4 TEAEs occurring in ≥3 pts were neutropenia (13 [50%]), febrile neutropenia (5 [19.2%]), thrombocytopenia (4 [15.4%]), COVID-19 (3 [11.5%]), maculo-papular rash (3 [11.5%]), and hypertension (3 [11.5%]). 1 pt discontinued tec + DR due to withdrawal of consent. 2 discontinued len due to TEAEs (gr 3 maculo-papular rash and gr 4 neutropenia). There was 1 death due to a TEAE in cycle 3 (pneumonia influenza). Overall response rate was 92.3% (complete response or better, 73.1%; very good partial response or better, 92.3%). Conclusions: These results from the first SRI of MajesTEC-7 demonstrate a manageable safety profile with early efficacy of tec + DR in NDMM. Two additional SRIs are ongoing investigating tec (less frequent dosing) + DR and talquetamab + DR.

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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

Open and Accepting

City of Hope Orange County Lennar Foundation Cancer Center

Irvine, CA

Open and Accepting

Connecticut

Neag Comprehensive Cancer Center UConn Health

Farmington, CT

Not Yet Accepting

Smilow Cancer Hospital at Yale New Haven

New Haven, CT

Open and Accepting

Georgia

Augusta University Medical Center

Augusta, GA

Not Yet Accepting

Kentucky

Norton Cancer Institute (St. Matthews) St. Matthews Campus

Louisville, KY

Open and 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

Boston Medical Center

Boston, MA

Not Yet Accepting

Michigan

Henry Ford Hospital

Detroit, MI

Not Yet Accepting

Mercy Health Cancer and Hematology Centers of West Michigan Lacks Cancer Center

Grand Rapids, MI

Open and Accepting

Ascension Providence Cancer Center (Foster Winter Drive)

Southfield, MI

Not Yet Accepting

Nebraska

Nebraska Cancer Specialists - Midwest Cancer Center Legacy Nebraska Cancer Specialists

Omaha, NE

Open and Accepting

University of Nebraska Medical Center Fred & Pamela Buffett Cancer Center

Omaha, NE

Open and Accepting

New Jersey

MD Anderson Cancer Center at Cooper Cooper University Hospital

Camden, NJ

Not Yet Accepting

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

New Brunswick, NJ

Not Yet Accepting

New Mexico

Christus St. Vincent Regional Medical Center

Santa Fe, NM

Open and Accepting

New York

Stony Brook University Hospital

Stony Brook, NY

Not Yet Accepting

North Carolina

Atrium Health's Levine Cancer Institute - Charlotte (Main) Atrium Health

Charlotte, NC

Not Yet Accepting

Duke Cancer Center Duke University Medical Center

Durham, NC

Not Yet Accepting

Durham Veterans Affairs Medical Center

Durham, NC

Open and Accepting

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

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

Dallas, TX

Not Yet Accepting

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

Fred Hutchinson Cancer Research Center University of Washington Cancer Consortium / SCCA

Seattle, WA

Not Yet Accepting

Washington, D.C.

Georgetown Lombardi Comprehensive Cancer Center MedStar Georgetown University Hospital

Washington, DC

Not Yet Accepting
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