Trials / Recruiting
RecruitingNCT05243797
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 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
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,594 (estimated)
- Sponsor
- European Myeloma Network B.V. · Network
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Teclistamab | Teclistamab will be administered via a subcutaneous injection (SC) |
| DRUG | Lenalidomide | Lenalidomide will be administered orally |
Timeline
- Start date
- 2022-09-08
- Primary completion
- 2028-04-01
- Completion
- 2032-04-01
- First posted
- 2022-02-17
- Last updated
- 2026-03-25
Locations
211 sites across 25 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czechia, Denmark, France, Germany, Greece, Ireland, Israel, Italy, Netherlands, Norway, Poland, Portugal, Serbia, South Korea, Switzerland, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05243797. Inclusion in this directory is not an endorsement.