ALTITUDE - ALTernating Induction Therapies to Achieve Undetectable Disease Endpoints: A Phase 1/2 Alternating Dara-RVd/Teclistamab-RVd in Transplant Eligible Standard-risk Newly Diagnosed Multiple Myeloma
Memorial Sloan Kettering Cancer Center
Summary
The purpose of this study is to find out whether Tec-RVd (teclistamab, lenalidomide, bortezomib, and dexamethasone) after 3 treatment Cycles of Dara-RVd (daratumumab, lenalidomide, bortezomib, and dexamethasone) is a safe treatment for people with newly diagnosed multiple myeloma (MM).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Documented multiple myeloma satisfying the International Myeloma Working Group (IMWG) diagnostic criteria36 (evidence of myeloma defining event attributed to underlying plasma cell disorder) with measurable disease defined as: 1. Clonal plasma cells in the bone marrow ≥ 10% or presence of a biopsy proven plasmacytoma 2. Measurable disease within the past 4 weeks defined by any of the following: * IgG myeloma: Serum monoclonal protein ≥ 1.0 g/dL or urine monoclonal protein ≥ 200 mg/24 hr; or * IgA, IgM, IgD, IgE multiple myeloma: serum M-protein ≥ 0.5…
Interventions
- DrugDara-RVd
This study is a phase 1/2 study design of alternating 6 cycles of Dara-RVd/Tec-RVd induction therapy
- DrugTec-RVd
This study is a phase 1/2 study design of alternating 6 cycles of Dara-RVd/Tec-RVd induction therapy
Locations (7)
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities)Middletown, New Jersey
- Memorial Sloan Kettering Bergen (Limited Protocol Activities)Montvale, New Jersey
- Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities)Commack, New York
- Memorial Sloan Kettering Westchester (Limited Protocol Activities)Harrison, New York
- Memorial Sloan Kettering Cancer Center (All Protocol Activities)New York, New York