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Proteasome Inhibitor

Cohort 1-Bortezomib (Velcade®) for Blood Cancers

Phase 1 & 2
Waitlist Available
Led By A. Samer Al-Homsi, MD
Research Sponsored by Spectrum Health Hospitals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed routinely by clinical and pathological evaluation. acute gvhd will be assessed up to day 150 post-transplant. chronic gvhd will be assess up to 2 years post-transplant.
Awards & highlights

Study Summary

The purpose of this study is to determine if Bortezomib, known commercially as Velcade is safe and tolerated at different dose levels (amounts) with high dose Cyclophosphamide to be used as graft versus host disease prevention after reduced-intensity allogeneic hematopoietic stem cell transplantation.

Eligible Conditions
  • Blood Cancers

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed routinely by clinical and pathological evaluation. acute gvhd will be assessed up to day 150 post-transplant. chronic gvhd will be assess up to 2 years post-transplant.
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed routinely by clinical and pathological evaluation. acute gvhd will be assessed up to day 150 post-transplant. chronic gvhd will be assess up to 2 years post-transplant. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose Limiting Toxicity
Secondary outcome measures
Engraftment
Other outcome measures
GVHD

Trial Design

3Treatment groups
Active Control
Group I: Cohort 1-Bortezomib (Velcade®)Active Control1 Intervention
Bortezomib (Velcade®) 0.7 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.
Group II: Cohort 2-Bortezomib (Velcade®)Active Control1 Intervention
Bortezomib (Velcade®) 1 mg/ m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.
Group III: Cohort 3-Bortezomib (Velcade®)Active Control1 Intervention
Bortezomib (Velcade®) 1.3 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.

Find a Location

Who is running the clinical trial?

Spectrum Health HospitalsLead Sponsor
64 Previous Clinical Trials
553,368 Total Patients Enrolled
Millennium Pharmaceuticals, Inc.Industry Sponsor
404 Previous Clinical Trials
46,886 Total Patients Enrolled
A. Samer Al-Homsi, MDPrincipal InvestigatorSpectrum Health Hospitals

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Post-Transplant Bortezomib and High Dose Cyclophosphamide as Graft-Versus-Host Disease (GVHD) Prophylaxis
A. Samer Al-Homsi 2012. "Post-Transplant Bortezomib and High Dose Cyclophosphamide as Graft-Versus-Host Disease (GVHD) Prophylaxis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01860170.
~2 spots leftby Apr 2025
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