Elotuzumab + Triple Therapy for Multiple Myeloma

Recruiting at 416 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Southwest Oncology Group

Must not be taking: Zidovudine, Stavudine

Disqualifiers: Non-secretory MM, Amyloidosis, POEMS, others

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

Compensation: Varies

Number of Visits: 3

142 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This partially randomized phase I/II trial studies the side effects and best dose of elotuzumab and to see how well it works when given together with lenalidomide, bortezomib, and dexamethasone in treating patients with newly diagnosed multiple myeloma that is likely to recur (come back), or spread (high-risk). Lenalidomide and bortezomib may stop the growth of multiple myeloma by blocking blood flow to the tumor. Also, bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as lenalidomide and dexamethasone, also work in different ways to kill cancer cells, by stopping them from dividing, or by stopping them from spreading. Giving elotuzumab together with lenalidomide, bortezomib, and dexamethasone may be a better way to block cancer growth.

Who Is on the Research Team?

Saad Usmani

Principal Investigator

SWOG Cancer Research Network

Are You a Good Fit for This Trial?

This trial is for newly diagnosed high-risk multiple myeloma patients without prior malignancies, except certain treated cases. They must not have POEMS syndrome or CNS involvement by MM, and should meet specific blood count and organ function criteria. Women of childbearing age need a negative pregnancy test and agreed birth control measures. Participants must consent to specimen banking for research.

Inclusion Criteria

I do not have POEMS syndrome.

My multiple myeloma has not spread to my brain or spinal cord.

I have hepatitis B or C but meet specific viral load criteria.

Exclusion Criteria

I am HIV+ and meet all required health criteria for the study.

I do not have non-secretory multiple myeloma or amyloidosis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction

Patients receive bortezomib, lenalidomide, and dexamethasone, with or without elotuzumab, in repeated 21-day cycles for 8 courses

24 weeks

Multiple visits per cycle for drug administration

Maintenance

Patients continue treatment with bortezomib, lenalidomide, and dexamethasone, with or without elotuzumab, in repeated 28-day cycles

Until disease progression or unacceptable toxicity

Monthly visits for drug administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 6 years

Every 3 months

What Are the Treatments Tested in This Trial?

Interventions

• Bortezomib
• Dexamethasone
• Elotuzumab
• Lenalidomide

Trial Overview The study tests if adding Elotuzumab to the combination of Lenalidomide, Bortezomib, and Dexamethasone improves treatment outcomes in high-risk multiple myeloma patients. It's a phase I/II trial that also aims to determine the best dose with acceptable side effects.

How Is the Trial Designed?

Group I: Arm II (bortezomib, lenalidomide, dexamethasone, elotuzumab) Experimental Treatment 5 Interventions

INDUCTION: Patients receive bortezomib, lenalidomide, and dexamethasone as in Arm I. Patients also receive elotuzumab IV on days 1, 8, and 15 of courses 1 and 2 and on days 1 and 11 of courses 3-8. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive bortezomib, lenalidomide, and dexamethasone as in Arm I. Patients also receive elotuzumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Group II: Arm I (bortezomib, lenalidomide, dexamethasone) Active Control 4 Interventions

INDUCTION: Patients receive bortezomib SC or IV on days 1, 4, 8, and 11; lenalidomide PO QD on days 1-14; and dexamethasone PO or IV on days 1, 2, 4, 5, 8, 9, 11, and 12. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity (patients who received a course of chemotherapy prior to registration will begin protocol treatment with course 2 and receive a total of 7 courses of protocol therapy). MAINTENANCE: Patients receive bortezomib SC or IV on days 1, 8, and 15; lenalidomide PO QD on days 1-21; and dexamethasone PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Bortezomib is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Velcade for:

• Multiple myeloma
• Mantle cell lymphoma

Approved in United States as Velcade for:

• Multiple myeloma
• Mantle cell lymphoma

Approved in Canada as Velcade for:

• Multiple myeloma
• Mantle cell lymphoma

Approved in Japan as Velcade for:

• Multiple myeloma
• Mantle cell lymphoma

Who Is Running the Clinical Trial?

Southwest Oncology Group

Lead Sponsor

Trials

389

Recruited

260,000+

SWOG Cancer Research Network

Lead Sponsor

Trials

403

Recruited

267,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+