A new investigational drug for multiple myeloma.

Trial ID:
Anuj Mahindra, MD
This study is evaluating the safety and tolerability of investigational drug, modakafusp alfa, in combination with standard of care therapy in adult patients with multiple myeloma who have been previously treated.

Patients will be assigned to one of four treatment groups based on disease status. The investigational study drug will be given by IV infusion once every 28 Days. Participants will receive treatment for 24-30 months and will continue with survival follow-up for a total of 5 years. All study visits will be completed at Scripps Clinic Torrey Pines.

Inclusion Criteria

Patients must:
  • Have received previous treatment for multiple myeloma;
  • Have suitable venous access for study drug administration and the study-required blood sampling;
  • Be willing and able to comply with all study requirements and to remain at the study center for the required duration during active treatment;
  • Be willing to return to the study center for the follow-up procedures and assessments
  • Meet all other eligibility criteria

Exclusion Criteria

Patients must not:
  • Be unable or unwilling to swallow oral medication or have a gastrointestinal disorder which interferes with the oral absorption or tolerance of oral (taken by mouth) combination agents;
  • Have a diagnosis of primary amyloidosis, Waldenström disease, monoclonal gammopathy of undetermined significance or smoldering MM, plasma cell leukemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or lymphoplasmacytic lymphoma;
  • Have had another cancer diagnosis within the previous 3 years which requires ongoing anti-cancer therapy. (Exceptions: treated basal cell or localized squamous skin carcinomas, localized prostate cancer, cervical carcinoma in situ, or breast cancer in situ).
  • Be pregnant or breastfeeding, or intending to become pregnant during the study or within 7Days (or longer) after the final dose of study medications.

Additional Info

  • Modakafusp alfa is a targeted drug therapy that is capable of binding to specific proteins found on the surface of multiple myeloma and immune cells.
  • The standard of care therapy agents used in this study are lenalidomide, pomalidomide, bortezomib, carfilzomib and daratumumab, and all are approved for the treatment of multiple myeloma.
  • Search NCT05556616 at https://clinicaltrials.gov website for more information.

Contact Info:

  • Clinical Research Services
  • CRSLeadership@scrippshealth.org