Carfilzomib + Lenalidomide + Dexamethasone with Stem Cell Transplant for Multiple Myeloma

Recruiting at 4 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Chicago

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: 3

76 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well carfilzomib, lenalidomide, and dexamethasone before and after stem cell transplant works in treating patients with newly diagnosed multiple myeloma. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from diving. Giving carfilzomib, lenalidomide, and dexamethasone before and after stem cell transplant may kill more cancer cells

Research Team

Andrzej Jakubowiak, MD, PhD

Principal Investigator

University of Chicago Comprehensive Cancer Center

Eligibility Criteria

This trial is for adults with newly diagnosed multiple myeloma who can follow the study plan, including birth control and testing. They must have certain blood cell counts, organ function, and agree to not get pregnant or father a child. People with recent major surgery, other cancers within 3 years (except some skin cancers), heart issues, uncontrolled diabetes or hypertension, active infections, HIV or hepatitis cannot join.

Inclusion Criteria

You are expected to live for more than 3 months.

Subjects must agree to adhere to all study requirements, including birth control measures and pregnancy testing, visit schedule, outpatient treatment, required concomitant medications, and laboratory monitoring

I have been newly diagnosed with myeloma and need chemotherapy.

Exclusion Criteria

You have had an allergic reaction to mannitol in the past.

I have Waldenstrom's macroglobulinemia or IgM myeloma.

I haven't had cancer in the last 3 years, except for certain skin, thyroid, cervix, or low-grade prostate cancers.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction Therapy

Participants receive dexamethasone, carfilzomib, and lenalidomide for 4 cycles

16 weeks

Multiple visits for drug administration

Transplant

Participants undergo autologous stem cell transplant

1-2 weeks

Inpatient stay for transplant procedure

Consolidation Therapy

Participants receive dexamethasone, carfilzomib, and lenalidomide for 4 cycles as in induction

16 weeks

Multiple visits for drug administration

Maintenance Therapy

Participants receive dexamethasone, carfilzomib, and lenalidomide for 10 cycles

40 weeks

Multiple visits for drug administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Every 3 months

Treatment Details

Interventions

• Autologous Hematopoietic Stem Cell Transplantation
• Carfilzomib
• Dexamethasone
• Lenalidomide

Trial Overview The trial tests carfilzomib, lenalidomide & dexamethasone before/after stem cell transplant in treating new multiple myeloma patients. Carfilzomib blocks enzymes cancer cells need; lenalidomide stimulates the immune system; dexamethasone kills or stops cancer cells from dividing.

Participant Groups

Group I: Treatment (dexamethasone, carfilzomib, lenalidomide) Experimental Treatment 5 Interventions

INDUCTION THERAPY: Patients receive dexamethasone IV or PO QD on days 1, 8, 15 and 22; carfilzomib IV over 10-30 minutes on days 1, 2, 8, 9, 15, and 16; and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.. TRANSPLANT: Patients undergo autologous stem cell transplant. CONSOLIDATION THERAPY: Patients receive dexamethasone, carfilzomib, and lenalidomide as in induction. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive dexamethasone and lenalidomide as in induction therapy and carfilzomib IV over 30 minutes on days 1, 2, 15, and 16. Treatment repeats every 28 days for 10 courses in the absence of disease progression or unacceptable toxicity.

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?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+