Combination Therapy for Multiple Myeloma

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Infections, Pregnancy, Active malignancy, 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

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

15 Participants Needed

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.

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.

Treatment Details

Interventions

• Elotuzumab

Trial Overview The 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

Group I: KRd-Elotuzumab Experimental Treatment 1 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 United States, European Union, Canada for the following indications:

Approved in United States as Empliciti for:

• Multiple myeloma

Approved in European Union as Empliciti for:

• Multiple myeloma

Approved in Canada as Empliciti for:

• Multiple myeloma

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Saad Z. Usmani, MD

Lead Sponsor

Trials

5

Recruited

70+

Manisha Bhutani

Lead Sponsor

Trials

2

Recruited

50+

Atrium Health Levine Cancer Institute

Collaborator

Trials

30

Recruited

4,700+

Bristol-Myers Squibb

Industry Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Levine Cancer Institute

Collaborator

Trials

6

Recruited

750+