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Proteasome Inhibitor

Stem Cell Transplant + Bortezomib for Blood Cancer

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
Must not have
Patients with active uncontrolled infections
Positive Beta Human chorionic gonadotropin (HCG) test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 30 days post transplant
Awards & highlights
No Placebo-Only Group

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.
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.
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
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My kidneys are functioning well, with a creatinine clearance rate of 60 ml/min or higher.
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I am eligible for a stem cell transplant for my blood cancer.
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I am between 18 and 65 years old and have a partially matched family donor for a transplant.
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My physical ability is severely limited.
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I have a donor ready for stem cell collection.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any active, uncontrolled infections.
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I am not pregnant and can bear children.
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I am HIV positive or have active hepatitis B or C.
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I have liver cirrhosis.
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My cancer has spread to my brain and is not under control.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
engraftment rate

Side effects data

From 2022 Phase 3 trial • 402 Patients • NCT03110562
43%
Weight decreased
29%
Cough
29%
Thrombocytopenia
29%
Nausea
29%
Decreased appetite
21%
Anaemia
21%
Constipation
21%
Diarrhoea
21%
Fatigue
14%
Oedema peripheral
14%
Pneumonia
14%
Neuropathy peripheral
14%
Paraesthesia
14%
Cataract
14%
Vomiting
14%
Headache
7%
Fungal skin infection
7%
Urinary tract infection
7%
Asthma
7%
Respiratory syncytial virus infection
7%
Neutropenia
7%
Peripheral swelling
7%
Mental status changes
7%
Lower respiratory tract infection
7%
Hyperthyroidism
7%
Back pain
7%
Pain in extremity
7%
Hyponatraemia
7%
Skin lesion
7%
Oropharyngeal pain
7%
Pyrexia
7%
Disturbance in attention
7%
Cardiac failure
7%
Hepatitis
7%
Pharyngitis
7%
Pollakiuria
7%
Non-cardiac chest pain
7%
C-reactive protein increased
7%
Taste disorder
7%
Haemorrhagic transformation stroke
7%
Abdominal pain
7%
Insomnia
7%
Dyspepsia
7%
Haemoglobin decreased
7%
Infection
7%
Hyperglycaemia
7%
Toothache
7%
Ecchymosis
7%
Upper respiratory tract infection
7%
Nasopharyngitis
7%
Viral infection
7%
Hypertension
7%
Muscular weakness
7%
Bronchiectasis
7%
Hypophagia
7%
Basal cell carcinoma
100%
80%
60%
40%
20%
0%
Study treatment Arm
SdX Arm: Selinexor + Dexamethasone
SVdX Arm: Selinexor + Bortezomib + Dexamethasone
SVd Arm: Selinexor + Bortezomib + Dexamethasone
Vd Arm: Bortezomib + Dexamethasone

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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 3
~1410

Find a Location

Who is running the clinical trial?

Henry Ford Health SystemLead Sponsor
311 Previous Clinical Trials
2,176,351 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
~0 spots leftby Jan 2025
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