drugset / Trial / NCT07485647

Identifying Effective and Cost-Conscious Maintenance Daratumumab Dosing

NCT07485647

Phase 2 Not yet recruiting 50 enrolled Eden Biltibo
NaSingle-groupOpen-labelTreatment

Summary

This phase II trial tests daratumumab given at a reduced frequency with lenalidomide for maintenance therapy for the cost effective treatment of patients with multiple myeloma post stem cell transplant. Darzalex Faspor (also known as Daratumumab-hyaluronidase) is a combination of two drugs used alone or with other drugs to treat adults with certain types of multiple myeloma or light chain amyloidosis. Daratumumab binds to a protein called CD38, which is found on some types of immune cells and cancer cells, including myeloma cells. Daratumumab may block CD38 and help the immune system kill cancer cells. Hyaluronidase allows daratumumab to be given by injection under the skin. Daratumumab and hyaluronidase can be given in less time than daratumumab alone, which is given as an infusion. Lenalidomide may stop or slow cancer cells by blocking the growth of new blood vessels necessary for tumor growth. Daratumumab-hyaluronidase is typically given every 4 weeks per standard of care. Giving it every 8 weeks for the first year followed by every 16 weeks for years 2 through 4 in combination with lenalidomide may be equally as effective and reduce costs and treatment visits for patients with multiple myeloma post stem cell transplant.

Timeline

Start
2026-05
Primary completion
2028-05
Completion
2029-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Daratumumab Monoclonal antibody 1800 mg Subcutaneous
Subject Lenalidomide Other / unclassified 15 mg Oral
Background rHuPH20 Protein / enzyme biologic 30000 iu Subcutaneous

Indications