NCI Protocol #10612 A Randomized Phase 2 Study of Daratumumab-Selinexor-Velcade-Dexamethasone (Dara-SVD) for High-Risk Newly Diagnosed Multiple Myeloma

Brief description of study

This is a Phase 2 study comparing whether the combination of study medicines daratumumab, selinexor, bortezomib, and dexamethasone is more effective than the standard medicine daratumumab, lenalidomide, bortezomib, and dexamethasone in patients newly diagnosed with high-risk multiple myeloma (HR MM).

Patients will be randomly divided into two groups. Group 1 will receive the combination of four study medicines, namely daratumumab, selinexor, bortezomib, and dexamethasone. Group 2 will receive a combination of four standard-of-care medicines, namely daratumumab, lenalidomide, bortezomib, and dexamethasone.

The study team will collect blood samples from all patients to see how their bodies are handling the medicines. Special scans will be taken for all patients to see how these medicines are changing their cancer. Study doctors will also collect bone marrow samples from all patients for special testing called minimum residual disease (MRD) testing to check for the presence of any cancer cells remaining in the body after treatment. All patients will be closely monitored for side effects and safety concerns.


Clinical Study Identifier: s24-00214
ClinicalTrials.gov Identifier: NCT06169215
Principal Investigator: Faith E. Davies.
Other Investigators: Caitlin Elizabeth Ordonez Ferri, Victoria Hohmann, Michael L. Grossbard, Gabrielle C Barshay, Bonnie Kiner-Strachan, Anne S. Renteria, Gareth J. Morgan, Bruce G Raphael, Stephanie M Erichsen, Oscar B Lahoud, John Leslie Vaughn, Mohammad Maher Abdul Hay, Marc Justin Braunstein, Amy L Sun, Maxim Kreditor, Jun Han Choi, David Kaminetzky, Ariel Karwat, Tibor Moskovits, Yovanna Giovanis.


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