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RecruitingLast updated: 2 April 2024

MajesTEC-9: This study is evaluating the effectiveness of immunotherapy, compared to targeted therapy and steroids, in people with relapsed or refractory multiple myeloma who have had prior therapyA Phase 3 Randomized Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma Who Have Received 1 to 3 Prior Lines of Therapy, Including an Anti-CD38 Monoclonal Antibody and Lenalidomide

Clinical summary

Summary

This study is recruiting people with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of treatment, including an Anti-CD38 monoclonal antibody and lenalidomide.

Eligible participants will be randomly allocated to one of two treatment arms.

In Arm A, participants will receive Teclistamab immunotherapy as monotherapy (by itself). Teclistamab will be administered subcutaneously (under the skin).

In Arm B, participants will receive the principal investigator's choice of either Pomalidomide, Bortezomib and Dexamethasone (PVd) or Carfilzomib and Dexamethasone (Kd).

Pomalidomide is a targeted therapy, and will be administered orally. Bortezomib is also a targeted therapy, and will be administered subcutaenously. Carfilzomib will be adminsitered intravenously.Dexamethasone is a type of steroid, and will be administered orally when given as part of PVd and given intravneously or orally as part of Kd.

Conditions

This trial is treating patients with multiple myeloma

Cancer

Blood Cancers Haematological

Age

People18+

Phase

III

Trial Acronym

MajesTEC-9

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

  • NCT05572515
  • CR109244; 64007957MMY3006; 2022-000928-37; 2023-503444-13-00

Trial sponsor

Janssen Research & Development, LLC

Scientific Title

A Phase 3 Randomized Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma Who Have Received 1 to 3 Prior Lines of Therapy, Including an Anti-CD38 Monoclonal Antibody and Lenalidomide

Eligibility

Inclusion

  • Documented diagnosis of multiple myeloma as defined by the criteria below: (a)Multiple myeloma diagnosis according to International Myeloma Working Group (IMWG) diagnostic criteria (b) Measurable disease at screening as defined by any of the following: (1) Serum M-protein level greater than or equal to (>=)0.5 grams per deciliter (g/dL) (central laboratory); or (2) Urine M-protein level >=200 milligrams (mg)/24 hours (central laboratory); or (3) Serum immunoglobulin free light chain >=10 milligrams per deciliter (mg/dL) (central laboratory) and abnormal serum immunoglobulin kappa lambda free light chain ratio
  • Received 1 to 3 prior lines of antimyeloma therapy including a minimum of 2 consecutive cycles of an anti- cluster of differentiation 38 (CD38) monoclonal antibody at the approved dosing regimen in any prior line and 2 consecutive cycles of lenalidomide in any prior line
  • Documented evidence of progressive disease or failure to achieve a response to last line of therapy based on investigator's determination of response by International myeloma working group (IMWG) criteria
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
  • A female participant must agree not to be pregnant, breast-feeding, or plan to become pregnant while enrolled in this study or within 6 months after the last dose of study treatment
  • Must be willing and able to adhere to the lifestyle restrictions specified in this protocol

Exclusion

  • Received any prior B cell maturation antigen (BCMA)-directed therapy
  • A participant is not eligible to receive PVd as control therapy if any of the following are present: (1) Received prior pomalidomide therapy, (2) Does not meet criteria for bortezomib retreatment (3) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to pomalidomide or bortezomib, (4) Grade 1 peripheral neuropathy with pain or Grade greater than or equal to (>=) 2 peripheral neuropathy as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0, (5) Received a strong cytochrome P (CYP) 3A4 inducer within 5 half-lives prior to randomization; A participant is not eligible to receive Kd as control therapy if any of the following are present:(1) Received prior carfilzomib therapy, (2) Uncontrolled hypertension, defined as an average systolic blood pressure greater than (>)159 millimeters of mercury (mmHg) or diastolic blood pressure >99 mmHg despite optimal treatment (3) Grade 2 peripheral neuropathy with pain or Grade >=3 peripheral neuropathy as defined by NCI-CTCAE Version 5.0, (4) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to carfilzomib (intolerance defined as prior therapy discontinued due to any adverse event [AE] related to carfilzomib)
  • Central nervous system (CNS) involvement or clinical signs of meningeal involvement of multiple myeloma.
  • Received a live, attenuated vaccine within 4 weeks before randomization
  • Plasma cell leukemia at the time of screening, Waldenstrom's macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, M-protein (POEMS) syndrome and skin changes, or primary amyloid light chain amyloidosis
  • Received a maximum cumulative dose of corticosteroids of >=140 mg of prednisone or equivalent within 14 days prior to randomization

Inclusion

  • You are able to swallow medication by mouth.
  • You have had a certain type of treatment or surgical procedure.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.

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.

Ask your doctor if this trial could be right for you.

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