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RecruitingLast updated: 28 March 2024

MajesTEC-7: This study is evaluating the effectiveness of immunotherapy in combination with other treatments, such as targeted therapy, in people multiple myelomaA Phase 3 Randomized Study Comparing Teclistamab in Combination With Daratumumab SC and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab SC and Lenalidomide (Tal-DR) Versus Daratumumab SC, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma Who Are Either Ineligible or Not Intended for Autologous Stem Cell Transplant as Initial Therapy

Trial purpose

Medical clipboardCancer treatment

Tumor type

Blood Cancers Haematological

Age

People18+

Trial acronym

MajesTEC-7

Clinical summary

Summary

This study is recruiting people with newly diagnosed multiple myeloma who are either ineligible or not intended for autologous stem cell transplant as initial therapy. Eligible participants will be randomly allocated to one of three treatment arms.

In Arm A (Experimental), participants will receive teclistamab as an injection under the skin (SC injection) in combination with daratumumab as an SC injection and lenalidomide which will be given orally.

In Arm B (Experimental), participants will receive talquetamab as an SC injection, in combination with daratumumab as an SC injection and lenalidomide which will be given orally.

In Arm C (Active Comparator), participants will receive daratumumab as an SC injection with lenalidomide which will be given orally, and dexamethasone which will be administered either orally or intravenously (IV). 

Conditions

This trial is treating people with newly diagnosed multiple myeloma

Eligibility

Inclusion

  • 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 participant must agree not to be pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 6 months after the last dose of study treatment
  • A participant must agree not to plan to father a child while enrolled in this study or within 100 days after the last dose of study treatment

Exclusion

  • Received any prior therapy for multiple myeloma or smoldering myeloma other than a short course of corticosteroids (not to exceed 40 milligrams [mg] of dexamethasone, or equivalent per day for a maximum of 4 days, total of 160 mg dexamethasone or equivalent). In addition, received a cumulative dose of systemic corticosteroids equivalent to greater than or equals to (>=)20 mg of dexamethasone during the Screening Phase
  • 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 or talquetamab excipients
  • Known contraindications to the use of daratumumab or lenalidomide per local prescribing information
  • Myeloma Frailty Index of >=2 with the exception of participants who have a score of 2 based on age alone

Inclusion

  • You are able to swallow medication by mouth.
  • You have been diagnosed with cancer, but have not received any treatment.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

  • NCT05552222 *
  • CR109237; 64007957MMY3005; 2022-000909-28; 2023-503442-30-00; CT1682

Trial sponsor

Janssen Research & Development, LLC

Scientific Title

A Phase 3 Randomized Study Comparing Teclistamab in Combination With Daratumumab SC and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab SC and Lenalidomide (Tal-DR) Versus Daratumumab SC, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma Who Are Either Ineligible or Not Intended for Autologous Stem Cell Transplant as Initial Therapy

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