18 Participants Needed

Chemotherapy + Stem Cell Transplant for Multiple Myeloma

Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: City of Hope Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.

Research Team

FS

Firoozeh Sahebi, MD

Principal Investigator

City of Hope Medical Center

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.
See 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.
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preparative Regimen

Patients receive fludarabine phosphate and melphalan, with or without total marrow irradiation, as a preparative regimen for allogeneic hematopoietic stem cell transplant

9 days
Daily visits for treatment administration

Transplant

All patients undergo allogeneic peripheral blood stem cell transplant

1 day
1 visit (in-person)

GVHD Prophylaxis

Patients receive tacrolimus and sirolimus to prevent graft-versus-host disease

Starting from day -3, ongoing

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 years
Follow-up at day 100, 6 months, and annually thereafter

Treatment Details

Interventions

  • Bortezomib
  • Fludarabine Phosphate
  • Melphalan
  • Peripheral Blood Stem Cell Transplantation
  • Total Marrow Irradiation
Trial Overview 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.
Participant Groups
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:

πŸ‡ͺπŸ‡Ί
Approved in European Union as Velcade for:
  • Multiple myeloma
  • Mantle cell lymphoma
πŸ‡ΊπŸ‡Έ
Approved in United States as Velcade for:
  • Multiple myeloma
  • Mantle cell lymphoma
πŸ‡¨πŸ‡¦
Approved in Canada as Velcade for:
  • Multiple myeloma
  • Mantle cell lymphoma
πŸ‡―πŸ‡΅
Approved in Japan as Velcade for:
  • Multiple myeloma
  • Mantle cell lymphoma

Find a Clinic Near You

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials
614
Recruited
1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of ServiceΒ·Privacy PolicyΒ·CookiesΒ·Security