Chemotherapy + Stem Cell Transplant for Multiple Myeloma

Recruiting in Palo Alto (17 mi)

Overseen byFiroozeh Sahebi, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: City of Hope Medical Center

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving chemotherapy drugs, such as fludarabine phosphate and melphalan, and total marrow irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib when given together with fludarabine phosphate and melphalan with or without total marrow irradiation in treating patients undergoing donor peripheral blood stem cell transplant for high-risk stage I or II multiple myeloma.

Eligibility Criteria

This trial is for high-risk stage I or II multiple myeloma patients who have relapsed on new therapies, had a previous stem cell transplant, or have specific genetic changes. They must be able to lie down for about an hour and meet certain health criteria like good heart function and kidney function. People with severe peripheral neuropathy, major medical issues, HIV, active hepatitis B or C, liver cirrhosis, or untreated infections cannot join.

Inclusion Criteria

Your disease has come back or not responded to new targeted treatments like thalidomide, lenalidomide, bortezomib, carfilzomib, or pomalidomide.

Recipient must have signed a voluntary, informed consent in accordance with institutional and federal guidelines

You have multiple myeloma that has come back after a previous treatment with your own stem cells.

+17 more

Exclusion Criteria

Major medical or psychiatric disorders that would seriously compromise patient tolerance of this regimen

DONOR: Donors will be excluded if for medical or psychological reasons they are unable to tolerate the procedure of peripheral stem cell donation

You have severe peripheral neuropathy.

+4 more

Participant Groups

The trial tests the side effects and best dose of bortezomib combined with fludarabine phosphate and melphalan chemotherapy drugs. Some patients will also receive total marrow irradiation before donor stem cell transplant to see if it helps stop cancer growth and prevents immune rejection.

2Treatment groups

Experimental Treatment

Group I: Group II (bortezomib, fludarabine phosphate, melphalanExperimental Treatment7 Interventions

Patients receive fludarabine phosphate IV and melphalan IV as in Stratum I. Patients also receive bortezomib IV on days -6, -3, 1, and 4.

Group II: Group I (bortezomib, fludarabine phosphate, TMI, melphalan)Experimental Treatment8 Interventions

Patients receive fludarabine phosphate IV on days -9 to -5 and melphalan IV on day -4. Patients also undergo TMI BID on days -9 to -7. If no DLT is observed in the first cohort, bortezomib IV will be added on days -6 and -3 for subsequent cohorts.

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

🇪🇺 Approved in European Union as Velcade for: