Combination Therapy for Multiple Myeloma

Recruiting in Palo Alto (17 mi)

Overseen byManisha Bhutani, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Wake Forest University Health Sciences

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

The study drug elotuzumab, has been clinically shown to be effective in treating relapsed/refractory MM in combination with either bortezomib, or lenalidomide and dexamethasone. Elotuzumab in combination with lenalidomide and dexamethasone is currently approved by the Food and Drug Administration (FDA) for the treatment of patients with multiple myeloma. Carfilzomib is also FDA approved for treating multiple myeloma and frequently given in combination with lenalidomide and dexamethasone for treatment of relapsed/refractory MM. Based on these findings, this study will look at how subjects with relapsed/refractory MM respond to a combination treatment with the following drugs: elotuzumab, carfilzomib, lenalidomide and dexamethasone. The combination of these four drugs is not FDA approved and is experimental.

Research Team

Manisha Bhutani, MD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

Adults with relapsed/refractory multiple myeloma who've had only one prior treatment can join. They must be in decent health, not pregnant, willing to use contraception, and have no major illnesses or surgeries recently. People with certain types of MM, CNS involvement, uncontrolled illness, recent investigational drug use or known allergies to the drugs are excluded.

Inclusion Criteria

I am able to get out of my bed or chair and move around.

My multiple myeloma has returned or didn't respond to treatment.

I am committed to using two effective birth control methods.

See 11 more

Exclusion Criteria

I am currently on medication for an infection.

I have another cancer that is growing and needs treatment.

My multiple myeloma has spread to my brain or spinal cord.

See 12 more

Treatment Details

Interventions

Elotuzumab (Monoclonal Antibodies)

Trial OverviewThe trial tests a combination of elotuzumab with carfilzomib, lenalidomide and dexamethasone in patients whose multiple myeloma has returned after treatment. This four-drug combo is experimental and aims to see how well it works together for this condition.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: KRd-ElotuzumabExperimental Treatment1 Intervention

Induction (4 28-day cycles): Carfilzomib (IV) @ 20 mg/m\^2, Day 1 of Cycle 1; @ 56 mg/m\^2, Day 8,15 of Cycle 1; @ 56 mg/m\^2, Day 1,8,15 of Cycles 2-4 Lenalidomide (Oral) @ 25 mg, once daily at bedtime on Days 1-21 of each cycle (Cycles 1-4) Dexamethasone @ 28 mg orally OR 8 mg IV, once weekly on Day 1,8,15,22 of Cycles 1-2; @28 mg orally OR 8 mg IV on Day 1 of Cycles 3-4 Elotuzumab (IV) @ 10 mg/kg, once weekly on Day 1,8,15,22 of Cycles 1-2; @ 20 mg/kg on Day 1 of Cycles 3-4 Maintenance (28-day cycles): Elotuzumab (IV) @ 20 mg/kg, Day 1 of each cycle (Cycles 1-n) Lenalidomide (Oral) @ 15 mg (or last tolerated dose if \<15 mg), once daily at bedtime on Days 1-21 of each cycle (Cycles 1-n)

Elotuzumab is already approved in Canada for the following indications: