NCT07485647

Identifying Effective and Cost-Conscious Maintenance Daratumumab Dosing

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Eden Biltibo · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Daratumumab and Recombinant Human Hyaluronidase	Daratumumab- will be administered at a dose of 1800 mg/30,000 units subcutaneously, every 8 weeks throughout Year 1 (injection to occur on day 1 of every other 28-day cycle for Cycle 1 through Cycle 11); throughout years 2 through 4 (beginning at Cycle 15, ending at Cycle 47), Daratumumab injections will occur every fourth cycle.
DRUG	Lenalidomide	Patients are scheduled to take an oral dose of Lenalidomide once each day (QD), starting at 10 mg per day for the first 3 months with an increase to 15 mg per day subsequently, if tolerated. Patients will do this continuously, until progressive disease or unacceptable adverse event

Timeline

• Start date: 2026-05-01
• Primary completion: 2028-05-01
• Completion: 2029-04-01
• First posted: 2026-03-20
• Last updated: 2026-03-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study