Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation (MajesTEC-4)

Stichting European Myeloma Network

Status and phase: Enrolling; Phase 3

Conditions: Multiple Myeloma

Treatments: Drug: Lenalidomide; Drug: Teclistamab

Study type: Interventional

Funder types: NETWORK; Industry

Identifiers

NCT05243797

EMN30/64007957MMY3003

Details and patient eligibility

About

This is a multicenter, randomized, open-label, Phase 3 study in participants with newly diagnosed multiple myeloma to evaluate the benefits of teclistamab in combination with lenalidomide and teclistamab alone versus lenalidomide alone as maintenance therapy after autologous stem cell transplant.

Enrollment: 1,572 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must have a new diagnosis of multiple myeloma according to IMWG criteria and have received induction +/- consolidation.
• Must have received only one line of therapy and achieved at least a partial response (≥PR) as per IMWG 2016 response criteria (Kumar 2016) without evidence of progression at the time of first treatment dose.
• Must not be intolerant to the starting dose of lenalidomide.
• Must not have received any maintenance therapy.
• Have an ECOG performance status score of 0, 1, or 2 at screening and immediately prior to the start of administration of study treatment
• Have clinical laboratory values within prespecified range.

Exclusion criteria

• Received any prior BCMA-directed therapy.
• Any previous therapy with an immune cell redirecting agent or gene modified adoptive cell therapy (eg, chimeric antigen receptor modified T cells, NK cells).
• Discontinued treatment due to any AE related to lenalidomide as determined by the investigator.
• Progressed on multiple myeloma therapy at any time prior to screening.
• Received a cumulative dose of corticosteroids equivalent to ≥140 mg of prednisone within the 14 days prior to first treatment dose.
• Received a live, attenuated vaccine within 4 weeks before first treatment dose. Non-live vaccines or non-replicating authorized for emergency use (eg. COVID-19) are allowed.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,572 participants in 3 patient groups

Arm A: Teclistamab-Lenalidomide (Tec-Len)

Experimental group

Description:

Teclistamab will be administered via a subcutaneous injection (SC)

Treatment:

Drug: Lenalidomide

Drug: Teclistamab

Arm B Lenalidomide Alone (Len)

Active Comparator group

Description:

Lenalidomide orally.

Treatment:

Drug: Lenalidomide

Arm C Teclistamab-Alone (Tec)

Experimental group

Description:

Teclistamab will be administered via a subcutaneous injection (SC)

Treatment:

Drug: Teclistamab