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A Phase 1b Open-label Study to Evaluate the Safety and Tolerability of Intravenous Modakafusp Alfa as Part of Combination Therapy in Adult Patients With Multiple Myeloma

Clinical Trial Details

This is a clinical trial for adults who have multiple myeloma (MM), a cancer of the white blood cells, that did not get better with the previous cancer treatment or has come back after getting better with an earlier treatment.

The purpose of this trial is to test the safety and tolerability, the anti-myeloma activity, and to identify the most appropriate dose of the research study drug, modakafusp alfa, in combination with other myeloma treatments for further evaluation.
   
Modakafusp alfa is an investigational drug being studied as a treatment for multiple myeloma. It has not been approved for treatment of multiple myeloma in any country, including by the U.S. Food and Drug Administration (FDA). Modakafusp alfa is a targeted drug therapy that is capable of binding to two proteins found on the surface of multiple myeloma and immune cells, CD38 and interferon alpha receptor. Researchers want to find out if modakafusp alfa can help patients with multiple myeloma. 
   
Modakafusp alfa is administered by intravenous infusion (IV) (needle administered into a vein), with a combination therapy.
   
Combination therapy agents used in this study are lenalidomide, pomalidomide, bortezomib, carfilzomib and daratumumab. They are all well-known agents and FDA-approved drugs for the treatment of multiple myeloma.
   
Participants will be in the study for approximately 24 to 30 months and will continue to follow-up phase for a total duration of approximately 5 years. 

Key Eligibility: 
  1. Open to men and women above the age of 18 who have been diagnosed with multiple myeloma
  2. Participants may not have received previous treatment with modakafusp alfa

 Detailed eligibility will be reviewed when you contact the study team

Study contact by location

Upper East Side - Manhattan

Contact(s)

Kathleen Pogonowski, RN
(646) 962-6500
kap9111@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2211025406

ClinicalTrials.gov:

NCT05556616

Sponsor:

TAK-573-1502

Status

Open to Enrollment

Age Group

Adult

Sponsor