A New Investigational Drug for Multiple Myeloma

Trial ID:
IRB-22-8052
Anuj Mahindra, MD
This study is evaluating the safety and tolerability of investigational drug, modakafulsp alfa, in combination with standard of care therapy for adult patients with multiple myeloma who have been previously treated.

Patients will be assigned to one of three treatment groups. Your provider will recommend a specific treatment group based upon the status of your disease, your prior treatment history and the enrollment status of each specific treatment group.

You will know which treatment group you have been assigned to, as recommended by your medical oncology provider. Each treatment group will include Modakafusp Alfa, given by intravenous infusion (IV) once every 4 weeks, in combination with one or two of the following FDA approved drugs: lenalidomide, pomalidomide, bortezomib or daratumumab

Inclusion Criteria

Patients must:

  • Have received previous treatment for multiple myeloma.

    Have suitable venous access for investigational 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 capable of independently managing all self-care and be ambulatory and up and about at least 50% of each day (normal waking hours).

    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 combination agents (taken by mouth).

    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 planning to become pregnant during the study or within 7Days (or longer) after the final dose of study medications.

Additional Info

The investigational study drug, 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 drugs used in this study are FDA approved for the treatment of multiple myeloma and include: lenalidomide, pomalidomide, bortezomib and daratumumab.

Search NCT05556616 at https://clinicaltrials.gov website for more information.

Contact Info:

  • Clinical Research Services
  • CRSLeadership@scrippshealth.org