Daratumumab + Lenalidomide for Multiple Myeloma

Overseen By Vanderbilt-Ingram Service Information Program

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Eden Biltibo

Must be taking: Proteasome inhibitors, Immunomodulatory drugs

Must not be taking: Live vaccines, Immunosuppressive therapy

Disqualifiers: Amyloidosis, Plasma cell leukemia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 8

Duration: 4 years

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

Eden Biltibo, MD, PhD

Principal Investigator

Vanderbilt-Ingram Cancer Center

Are You a Good Fit for This Trial?

Inclusion Criteria

Compliance with pregnancy prevention measures

I am 18-70, newly diagnosed with multiple myeloma, had ASCT, and responded well to treatment.

I am fully active or can care for myself with little help.

Exclusion Criteria

All patients with concomitant amyloidosis or plasma cell leukemia

Participation in other investigational studies

I have specific medical conditions or treatments that may affect my eligibility.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Daratumumab-hyaluronidase is given every 8 weeks for the first year followed by every 16 weeks for years 2 through 4 in combination with lenalidomide

4 years

Visits every 8 weeks in year 1, every 16 weeks in years 2-4

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Daratumumab and Recombinant Human Hyaluronidase
• Lenalidomide

How Is the Trial Designed?

Group I: Daratumumab + Lenalidamide Experimental Treatment 2 Interventions

subcutaneous Q8W/Q16W daratumumab maintenance therapy in combination with lenalidomide with a historical cohort that used lenalidomide/Q4W daratumumab maintenance therapy

Who Is Running the Clinical Trial?

Eden Biltibo

Lead Sponsor