Identifying Effective and Cost-Conscious Maintenance Daratumumab Dosing

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Eden Biltibo
Study ID
NCT07485647
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Daratumumab and Recombinant Human Hyaluronidase — DRUG
    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.
  • Lenalidomide — DRUG
    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

Study Details

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.

Key Dates

Start date
May 31, 2026
Status verified
Mar 2026
Primary completion
May 31, 2028
Completion
Apr 30, 2029

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Daratumumab + Lenalidamide
    subcutaneous Q8W/Q16W daratumumab maintenance therapy in combination with lenalidomide with a historical cohort that used lenalidomide/Q4W daratumumab maintenance therapy

Primary Outcome Measure

Percentage of participants with minimal residual disease (MRD) negative status [ Time Frame: 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt University Medical CenterNashvilleTennessee37203
Eden Biltibo
Eden Biltibo (PRINCIPAL_INVESTIGATOR)

Find similar trials in Nashville, TN

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Vanderbilt University Medical Center· Nashville, TN

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