Carfilzomib + Lenalidomide + Dexamethasone for Multiple Myeloma

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: National Cancer Institute (NCI)

Must not be taking: Investigational agents

Disqualifiers: Multiple myeloma, Hypertension, Diabetes, 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: 4

55 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Background: * Multiple myeloma is a blood cancer that affects the plasma cells. These cells help produce antibodies and fight infection. Smoldering multiple myeloma (SMM) is a related condition that may develop into multiple myeloma. The current standard of care for SMM is close follow-up without treatment until multiple myeloma develops. However, researchers are studying possible treatments for SMM itself. One possible treatment involves a combination of cancer treatment drugs. * Lenalidomide is a drug that may help reduce or prevent the growth of cancer cells. Dexamethasone is a steroid that is often given with other anti-cancer drugs. These two drugs are an approved treatment for multiple myeloma that has not responded to at least one other treatment. Carfilzomib is an experimental drug that has been effective in treating multiple myeloma. Researchers want to combine these three drugs to see if they are a safe and effective treatment for SMM. Objectives: - To see if carfilzomib, lenalidomide, and dexamethasone are a safe and effective treatment for smoldering multiple myeloma. Eligibility: - Individuals at least 18 years of age who have SMM that is likely to progress to multiple myeloma. Design: * Participants will be screened with a physical exam and medical history. They will also have blood and urine tests, and baseline bone marrow scans. Bone marrow samples will also be collected. * Participants will have eight 28-day cycles of treatment with the three study drugs. The drugs will be given as tablets or as infusions. Treatment will be monitored with frequent blood tests and study visits. * After the first four cycles, participants who are eligible for a stem cell transplant will have their stem cells collected and stored for future use. * At the end of eight cycles, participants whose disease has not progressed will have up to 12 more cycles of treatment with lenalidomide tablets alone.

Who Is on the Research Team?

Elizabeth Hill, M.D.

Principal Investigator

National Cancer Institute (NCI)

Are You a Good Fit for This Trial?

Adults with Smoldering Multiple Myeloma (SMM) likely to progress to multiple myeloma can join. They must understand and sign consent, agree to use contraception, have no other cancer treatments in the last 4 weeks, and meet health criteria including normal organ function and 'high-risk' SMM status.

Inclusion Criteria

My condition is confirmed as Smoldering Multiple Myeloma by a recognized lab.

I can take care of myself but might not be able to do heavy physical work.

I agree to use birth control during the study.

Exclusion Criteria

I have a GI condition that affects my body's ability to absorb medications.

I do not have severe nerve pain or damage.

You are currently taking any other experimental medications.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Induction Treatment

Participants receive 8 cycles of combination therapy with carfilzomib, lenalidomide, and dexamethasone

8 months

Frequent visits for blood tests and study visits

Stem Cell Collection

Eligible participants may undergo stem cell collection after 4 cycles of therapy

1-2 weeks

Maintenance Treatment

Participants receive up to 12 cycles of lenalidomide tablets alone if disease has not progressed

12 months

Monthly visits for laboratory evaluations

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years

Every 3 months during maintenance and follow-up phases

What Are the Treatments Tested in This Trial?

Interventions

• Carfilzomib
• Dexamethasone
• Lenalidomide

Trial Overview The trial tests a combination of Carfilzomib, Lenalidomide (Revlimid), and Dexamethasone for treating SMM. Participants will undergo eight cycles of treatment with these drugs followed by up to twelve additional cycles with just Lenalidomide if their disease doesn't progress.

How Is the Trial Designed?

Group I: Group B - Carfilzomib with Revlimid and Dexamethasone Experimental Treatment 3 Interventions

Carfilzomib (intravenous (IV), Days 1, 2, 8, 9, 15, and 16 of the 28-day cycle); Revlimid (by mouth (PO), Days 1-21 of the 28-day cycle); and Dexamethasone (PO or IV, Days 1, 2, 8, 9, 15, 16, 22, and 23 of the 28-day cycle)

Group II: Group A - (closed) - Carfilzomib with Revlimid and Dexamethasone Experimental Treatment 3 Interventions

Carfilzomib (intravenous (IV), Days 1, 2, 8, 9, 15, and 16 of the 28-day cycle); Revlimid (by mouth (PO), Days 1-21 of the 28-day cycle; exception: not given on cycle 1 day 1); and Dexamethasone (PO or IV, Days 1, 2, 8, 9, 15, 16, 22, and 23 of the 28-day cycle; exception: not given on cycle 1 day 1)

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

Approved in United States as Kyprolis for:

• Multiple myeloma

Approved in European Union as Kyprolis for:

• Multiple myeloma

Approved in Canada as Kyprolis for:

• Multiple myeloma

Approved in Japan as Kyprolis for:

• Multiple myeloma

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+