← Back to Search

Proteasome Inhibitor

Stem Cell Transplant + Bortezomib for Blood Cancer

Q: Are there any life-threatening dangers associated with taking Bortezomib?

Bortezomib garnered a safety score of 2. Although there is some clinical evidence to support its safety, efficacy has not been explored in any trials.

Q: Are we still recruiting participants for this research?

That is accurate. The data on clinicaltrials.gov makes it clear that this trial began recruiting patients on 3/8/2016 and is still actively looking for 15 individuals across 1 location.

Q: Does this clinical trial have an age limit? If so, what is it?

The age range for patients eligible to enroll in this clinical trial is 18-65.

Q: What are the primary reasons that doctors recommend Bortezomib?

Bortezomib is not only commonly used to treat <a href="https://www.withpower.com/clinical-trials/multiple-sclerosis">multiple sclerosis</a>, but also various other conditions such as mixed-cell type <a href="https://www.withpower.com/clinical-trials/lymphoma">lymphoma</a>, <a href="https://www.withpower.com/clinical-trials/leukemia">leukemia</a>, myelocytic, acute, and retinoblastoma.

Q: What are some other use cases for Bortezomib that have been investigated?

At the current moment, there are 959 different trials being conducted for Bortezomib. 185 of those active trials are in their third stage of testing. Although most research is based in Philadelphia, <a href="https://www.withpower.com/clinical-trials/pennsylvania">Pennsylvania</a>, studies for this treatment can be found at 34802 locations worldwide.

Q: For what kinds of patients is this trial meant?

This study is recruiting 15 people between the ages of 18 and 65 who currently have hematologic neoplasms. Participants must also meet the following criteria:-18-65 years old patient lacking a matched related donor or unrelated donor but have a related haploidentical donor (&#x3C;/= 7/8 allele match at the A, B, C, DR loci with a minimum match of 5/10 is required) is identified-Candidate for stem cell <a href="https://www.withpower.com/clinical-trials/transplant">transplant</a> in a malignant hematological condition-Karnofsky Performance Scale 0-1-Available donor able to undergo a Peripher

Q: How many individuals have signed up to participate in this clinical trial?

The clinicaltrials.gov website does show that this study is looking for patients right now. The trial was originally posted on March 8th, 2016 and the most recent update was on December 23rd, 2021. They are hoping to have 15 people participate at 1 location.

Phase 2

Recruiting

Research Sponsored by Henry Ford Health System

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Serum creatinine clearance >/=60 ml/min (calculated with Cockroft-Gault formula)

Candidate for stem cell transplant in a malignant hematological condition

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 30 days post transplant

Awards & highlights

Study Summary

This trial is testing a new way to do stem cell transplants for people with blood cancers who don't have a matching donor. The new method uses a haploidentical (partially matched) donor, and post-transplant cyclophosphamide and bortezomib. The goal is to see if this method leads to successful engraftment (when transplanted cells start to grow and make new blood cells).

Who is the study for?

This trial is for adults aged 18-65 with blood cancers who lack a fully matched donor but have a related half-matched (haploidentical) donor. They should be fit for stem cell transplant, have good organ function, and provide consent. Those with uncontrolled infections, suitable donors, HIV/hepatitis B/C, liver cirrhosis, brain involvement by cancer or pregnant women can't join.Check my eligibility

What is being tested?

The study tests the effectiveness of using both Cyclophosphamide and Bortezomib after a haploidentical peripheral blood stem cell transplant in patients with hematologic malignancies to prevent GVHD and improve immune recovery.See study design

What are the potential side effects?

Potential side effects may include reactions to the infusion of cells or drugs used in the procedure like fatigue, nausea, risk of infection due to immune suppression from chemotherapy agents like Cyclophosphamide and possible nerve damage known as neuropathy from Bortezomib.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My kidneys are functioning well, with a creatinine clearance rate of 60 ml/min or higher.

Select...

I am eligible for a stem cell transplant for my blood cancer.

Select...

I am between 18 and 65 years old and have a partially matched family donor for a transplant.

Select...

My physical ability is severely limited.

Select...

I have a donor ready for stem cell collection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 30 days post transplant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 30 days post transplant

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 30 days 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

engraftment rate

Side effects data

From 2008 Phase 2 trial • 20 Patients • NCT00006184

100%

Injection site reaction

40%

Fatigue (asthenia, lethargy, malaise)

30%

Pruritus

30%

Platelets

30%

Chest pain (non-cardiac and non-pleuritic)

30%

Bone pain

30%

Headache

30%

Myalgia (muscle ache)

30%

SGPT (ALT)

30%

Abdominal pain or cramping

20%

Alkaline phosphatase

20%

Hypokalemia

20%

Dizziness/lightheadedness

20%

Arthralgia (joint pain)

20%

Hypomagnesemia

20%

Pain - Other

20%

Rash/desquamation

20%

Rigors/chills

20%

SGOT (AST)

10%

Hypoalbuminemia

10%

Hypocalcemia

10%

Hot flashes/flushes

10%

Hypophosphatemia

10%

Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)

10%

Lymphopenia

10%

Erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis

10%

Dry skin

10%

Constipation

10%

Hypotension

10%

Joint, muscle, or bone (osseous)- Other (Calf cramping)

10%

Hypercalcemia

10%

Skin-Other (Drug reaction face, hands, neck)

10%

Hematologic-Other (Splenomegaly in donor-resolved)

10%

Dyspnea (shortness of breath)

10%

Rash/desquamation for BMT

10%

Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)

100%

80%

60%

40%

20%

Study treatment Arm

Donor - Vaccination Generation Group

Recipient - Chemotherapy Group

Trial Design

1Treatment groups

Experimental Treatment

Group I: BortezomibExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bortezomib

2005

Completed Phase 2

~1140

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Henry Ford Health SystemLead Sponsor

300 Previous Clinical Trials

2,099,867 Total Patients Enrolled

Media Library

Bortezomib (Proteasome Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03850366 — Phase 2

Blood Cancers Research Study Groups: Bortezomib

Blood Cancers Clinical Trial 2023: Bortezomib Highlights & Side Effects. Trial Name: NCT03850366 — Phase 2

Bortezomib (Proteasome Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03850366 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any life-threatening dangers associated with taking Bortezomib?

"Bortezomib garnered a safety score of 2. Although there is some clinical evidence to support its safety, efficacy has not been explored in any trials."

Answered by AI

Are we still recruiting participants for this research?

"That is accurate. The data on clinicaltrials.gov makes it clear that this trial began recruiting patients on 3/8/2016 and is still actively looking for 15 individuals across 1 location."

Answered by AI

Does this clinical trial have an age limit? If so, what is it?

"The age range for patients eligible to enroll in this clinical trial is 18-65."

Answered by AI

What are the primary reasons that doctors recommend Bortezomib?

"Bortezomib is not only commonly used to treat multiple sclerosis, but also various other conditions such as mixed-cell type lymphoma, leukemia, myelocytic, acute, and retinoblastoma."

Answered by AI

What are some other use cases for Bortezomib that have been investigated?

"At the current moment, there are 959 different trials being conducted for Bortezomib. 185 of those active trials are in their third stage of testing. Although most research is based in Philadelphia, Pennsylvania, studies for this treatment can be found at 34802 locations worldwide."

Answered by AI

For what kinds of patients is this trial meant?

"This study is recruiting 15 people between the ages of 18 and 65 who currently have hematologic neoplasms. Participants must also meet the following criteria:-18-65 years old patient lacking a matched related donor or unrelated donor but have a related haploidentical donor (</= 7/8 allele match at the A, B, C, DR loci with a minimum match of 5/10 is required) is identified-Candidate for stem cell transplant in a malignant hematological condition-Karnofsky Performance Scale 0-1-Available donor able to undergo a Peripher"

Answered by AI

How many individuals have signed up to participate in this clinical trial?

"The clinicaltrials.gov website does show that this study is looking for patients right now. The trial was originally posted on March 8th, 2016 and the most recent update was on December 23rd, 2021. They are hoping to have 15 people participate at 1 location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

HLA-Haploidentical Peripheral Blood Stem Cell Transplantation With Post-transplant Cyclophosphamide and Bortezomib

Shatha Farhan 2016. "HLA-Haploidentical Peripheral Blood Stem Cell Transplantation With Post-transplant Cyclophosphamide and Bortezomib". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03850366.

All > Velcade