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

Condition(s) studied

Investigational drug(s) / intervention(s)

Teclistamab: Teclistamab will be administered via a subcutaneous injection (SC)

Lenalidomide: Lenalidomide will be administered orally

Study summary

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.

Eligibility

Primary outcome measure(s)

• Progression Free Survival (PFS) — 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.
• Minimal Residual Disease (MRD)-negative Complete Response (CR) — at month 12
  12-month MRD-negative CR is defined as participants who achieve MRD-negative status at 12 months, as determined by next-generation flow cytometry (NGF) with sensitivity of 10\^-5, prior to progressive disease or subsequent anti-myeloma therapy, whichever is earlier, and who also achieve CR of better, according to IMWG criteria.

Trial sites (212)

+ 172 more sites — see the full list on the official registry below.

On this site

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