Identifying Effective and Cost-Conscious Maintenance Daratumumab Dosing

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorEden Biltibo

About this trial

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.

Eligibility criteria

Qualifiers

Signed and dated written informed consent

Male or female newly diagnosed multiple myeloma (NDMM) patients 18 to 70 years old on the day of signing informed consent who had ASCT with post-ASCT response of partial response (PR) or better as defined by International Myeloma Working Group (IMWG). The induction regimen should include a proteasome inhibitors (PI), immunomodulatory drugs (IMiD) and anti-CD38 monoclonal antibody

Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

Patients with high-risk and international staging system (ISS) stage-III disease in 15% of the intent to treat population. Patients with 1q gain, 1p deletion, del17p, t[4;14], or t[14;16] by fluorescence in situ hybridization [FISH] will be categorized as having high risk disease

Disqualifiers

Corrected serum calcium, ≤ 14.0 mg/dL (≤ 3.5 mmol/L)

Platelet count, ≥ 50 × 10^9/L (≥ 50 × 10^9/L if ≥ 50% of the bone marrow was infiltrated with multiple myeloma [MM] cells)

Alanine aminotransferase and aspartate aminotransferase levels < 2.5 times the upper limit of normal

Creatinine clearance ≥ 30 mL/min (per institutional standard)

Trial design

Treatments tested in this trial

  • Daratumumab and Recombinant Human Hyaluronidase
  • Lenalidomide

Treatment groups

50 Participants
are divided into 1 treatment group

Sponsors and collaborators

Eden Biltibo

Lead sponsor

Vanderbilt-Ingram Cancer Center

Sponsor institution