Phase 3 Study of Teclistamab with Lenalidomide or Alone Versus Lenalidomide Alone for Maintenance Therapy in Newly Diagnosed Multiple Myeloma Patients After Stem Cell Transplant
Sponsor: Stichting European Myeloma Network
ClinicalTrials ID:NCT05243797
This clinical trial is testing whether the drug teclistamab, used alone or with lenalidomide, is more effective than lenalidomide alone as a maintenance treatment for patients with newly diagnosed multiple myeloma who have undergone a stem cell transplant.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The study aims to find out if using teclistamab, either by itself or with lenalidomide, can provide better maintenance therapy compared to using lenalidomide alone in patients who have recently been diagnosed with multiple myeloma and have had a stem cell transplant. This trial involves multiple centers and participants will be randomly assigned to different treatment groups.
Eligibility Criteria
Inclusion Criteria
- Newly diagnosed with multiple myeloma and have received initial treatment.
- Have only had one type of treatment and shown at least a partial improvement without the disease getting worse.
- Can tolerate the starting dose of lenalidomide.
- Have not received any maintenance therapy before.
- Have a performance status score of 0, 1, or 2, indicating good overall health.
- Have lab test results within a specific range.
Exclusion Criteria
- Have received any previous treatment targeting BCMA.
- Have had any therapy involving redirected immune cells or gene-modified cell therapy, like CAR-T cells.
- Stopped lenalidomide treatment due to side effects.
- Experienced disease progression before the study.
- Have taken a high dose of corticosteroids recently.
- Have received a live vaccine within four weeks before starting the study treatment. Non-live vaccines, like those for COVID-19, are allowed.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| The University of Arizona Cancer Center | 85004 | Phoenix | Arizona |
| University of California-Davis Cancer Center | 95817 | Sacramento | California |
| University of Colorado Hospital | 80045 | Aurora | Colorado |
| Colorado Blood Cancer Institute | 80218 | Denver | Colorado |
| Yale New Haven Hospital | 06519 | New Haven | Connecticut |
| Blood & Marrow Transplant Center, Florida Hospital Medical Group | 32804 | Orlando | Florida |
| Moffitt at Memorial Healthcare System | 33612 | Tampa | Florida |
| University of Illinois Medical Center at Chicago | 60612 | Chicago | Illinois |
| IU Health Blood and Bone Marrow Stem Cell Transplant and Immune Cell Therapy Program | 46202 | Indianapolis | Indiana |
| Greenebaum Cancer Center UM of MD | 21201 | Baltimore | Maryland |
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