Recruiting NCT05243797

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

Phase III Interventional Multiple Myeloma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Teclistamab, Lenalidomide.
Who it may be relevant to: Registry conditions: Multiple Myeloma. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Australia, Austria, Belgium +20
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

Drug Teclistamab
Teclistamab will be administered via a subcutaneous injection (SC)
Drug Lenalidomide
Lenalidomide will be administered orally

Primary outcome measures

Progression Free Survival (PFS) [Time frame: from randomization to the date of disease progression or death (approximately up to 8 years)]
Minimal Residual Disease (MRD)-negative Complete Response (CR) [Time frame: at month 12]

Secondary outcome measures (7)

Comparison of efficacy [Time frame: from randomization to the date of disease progression or death (approximately up to 8 years)]
Overall Survival (OS) [Time frame: from the date of from randomization to the date the subject's death, assessed up to 8 years]]
Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core module (EORTC QLQ-C30) score and the difference between-treatment arms [Time frame: baseline up to 8 years]
EQ-5D-5L health utility values and the difference between-treatment arms [Time frame: baseline up to 8 years]
MySIm-Q Symptom and Impacts in Patients With Multiple Myeloma and the difference between treatment arms [Time frame: baseline up to 8 years]
PRO-CTCAE to evaluate symptomatic toxicities by self-report and the difference between treatment arms [Time frame: baseline up to week 24]
PGIS to evaluate the patient global impression of severity of the Multiple Myeloma and the difference between treatment arms [Time frame: baseline up to 8 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Open label
Primary purpose: Treatment