Trattamento

Experimental: Arm A: Teclistamab-Lenalidomide (Tec-Len)
Active Comparator: Arm B Lenalidomide Alone (Len)
Lenalidomide orally.

Obiettivo primario

1. Progression Free Survival (PFS) [ Time Frame: from randomization to the date of disease progression or death (approximately up to 8 years) ]
   PFS is defined as the time from the date of randomization to the date of disease progression (as assessed by IMWG criteria) or death due to any cause, whichever occurs first.

Criteri di inclusione

• 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.

Criteri di esclusione

• 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 (see Appendix 12).
• Received a live, attenuated vaccine within 4 weeks before first treatment dose. Non-live vaccines authorized for emergency use (eg. COVID-19) are allowed.