Bortezomib for Graft vs Host Disease

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Graft vs Host Disease+1 More
Bortezomib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial is for adult patients with blood cancers who are undergoing a stem cell transplant from a matched donor. The patients will receive standard care, as well as investigational drugs to help prevent GvHD.

Eligible Conditions
  • Graft vs Host Disease
  • Disease

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 8 Secondary · Reporting Duration: Day +1 to Day +730

Day +1
Secondary graft failure
Day +1 to Day +30
Poor graft function
Primary graft failure
Day +1 to Day +365
Chronic GvHD
Day +1 to Day +730
GvHD and relapse-free survival (GRFS)
Overall survival (OS)
Relapse rate (RR)
Treatment-related mortality (TRM)
Day+1 to Day +120
Phase I:Incidence Dose limiting toxicity (DLT)
Phase II: Grades II-IV Acute GvHD

Trial Safety

Safety Progress

1 of 3

Side Effects for

Recipient - Chemotherapy Group
100%Hemoglobin (hgb)
90%Nausea
80%Neutrophils/granulocytes (ANC/AGC) for BMT
80%SGPT (ALT)
80%Vomiting
80%Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
80%Injection site reaction
80%Leukocytes (total WBC)
80%SGOT (AST)
70%Creatinine
70%Diarrhea (without colostomy)
70%Neutrophils/granulocytes (ANC/AGC)
70%Lymphopenia
70%Platelets
60%Infection (documented clinically or microbiologically) with Grade 3 or 4 neutropenia
60%Bone pain
60%Rash/desquamation
60%Platelets for BMT
60%Transfusion: Platelets for BMT
60%Infection without neutropenia
60%Fatigue (asthenia, lethargy, malaise)
60%Hypomagnesemia
60%Transfusion: pRBCs for BMT
60%Hyponatremia
50%Cough
50%Neuropathy-sensory
50%Hypoxia
40%Leukocytes (total WBC) for BMT
40%Catheter-related infection
40%Pain - Other
40%Dyspnea (shortness of breath)
40%Hypoalbuminemia
40%Hypocalcemia
40%Stomatitis/pharyngitis (oral/pharyngeal mucositis)
40%Bilirubin
30%Hypotension
30%Hemorrhage/bleeding without grade 3 or 4 thrombocytopenia
30%Hypophosphatemia
30%Hyperglycemia
30%Constipation
30%Alkaline phosphatase
30%Febrile neutropenia
30%Transfusion: pRBCs
30%Diarrhea for BMT
30%Anorexia
20%Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)
20%Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
20%Chest pain (non-cardiac and non-pleuritic)
20%Hypertension
20%Metabolic-Other (Hyperbilirubinemia; hyperbilirubinemia r/t GVH)
20%Rigors/chills
20%Sweating (diaphoresis)
20%Urinary frequency/urgency
20%Abdominal pain or cramping
20%Edema
20%Hypokalemia
20%Rash/desquamation for BMT
20%Flushing
10%Injection site reaction, bilat legs
10%Mood alteration::Depression
10%Transfusion: Platelets
10%Acidosis (metabolic or respiratory)
10%Dizziness/lightheadedness
10%Infection w/out neutropenia, catheter related
10%Stomatitis/pharyngitis (oral/pharyngeal mucositis) for BMT
10%Joint, muscle, or bone (osseous)- Other (Calf cramping)
10%Pulmonary-Other (URI)
10%Pleural effusion (non-malignant)
10%Proteinuria
10%Rectal bleeding/hematochezia
10%Salivary gland changes
10%Weight loss
10%Allergic reaction/hypersensitivity (including drug fever)
10%Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia
10%Constitutional Symptoms-Other (CGVHD-skin)
10%Erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis
10%Hemoptysis
10%Infection without neutropenia, wound
10%Infection without neutropenia, blood
10%Hypothyroidism
10%Infection without neutropenia, C-diff
10%Infection: blood
10%Infection without neutropenia, Nasal Pharynx
10%Insomnia
10%Injection site reaction, bilat arms
10%Lymphatics-Other (Adenopathy)
10%Lymphatics
10%Thrombosis/embolism
10%Skin-Other (Drug reaction face, hands, neck)
10%Vasovagal episode
10%Voice changes/stridor/larynx (e.g., hoarseness, loss of voice, laryngitis)
10%Neuropathic pain
10%Nausea and vomiting
10%Myalgia (muscle ache)
10%Pruritus
10%Dyspareunia
10%Mood alteration-euphoria
10%Pericardial effusion/pericarditis
10%Pigmentation changes (e.g., vitiligo)
10%Pneumonitis/pulmonary infiltrates
10%Metabolic-Other (GGT)
10%Amylase
10%Allergy - Other (Transfusion reaction (platelets)
10%Diarrhea
10%Headache
10%Ileus (or neuroconstipation)
10%Mood alteration-depression
10%Ocular-Other (Ocular cGVHD)
10%Cataract
10%Neurologic-Other (Neuropathy)
10%Bilirubin - graft versus host disease (GVHD)
10%Taste disturbance (dysgeusia)
10%Hypermagnesemia
10%Infection, Other (Upper respiratory infection (URI))
10%Diarrhea (without colostomy) BMT
10%Diarrhea (with colostomy)
This histogram enumerates side effects from a completed 2008 Phase 2 trial (NCT00006184) in the Recipient - Chemotherapy Group ARM group. Side effects include: Hemoglobin (hgb) with 100%, Nausea with 90%, Neutrophils/granulocytes (ANC/AGC) for BMT with 80%, SGPT (ALT) with 80%, Vomiting with 80%.

Trial Design

1 Treatment Group

Participants with hematological malignancies
1 of 1

Experimental Treatment

74 Total Participants · 1 Treatment Group

Primary Treatment: Bortezomib · No Placebo Group · Phase 1 & 2

Participants with hematological malignanciesExperimental Group · 3 Interventions: Cyclophosphamide, Abatacept, Bortezomib · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~4020
Abatacept
2005
Completed Phase 4
~111470
Bortezomib
2005
Completed Phase 2
~1360

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: day +1 to day +730

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,255 Previous Clinical Trials
743,757 Total Patients Enrolled
3 Trials studying Graft vs Host Disease
161 Patients Enrolled for Graft vs Host Disease
Ahmad Al-Homsi, MDPrincipal InvestigatorNYU Langone Health
1 Previous Clinical Trials
23 Total Patients Enrolled
1 Trials studying Graft vs Host Disease
23 Patients Enrolled for Graft vs Host Disease

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a score of 70% or higher on the Karnofsky score.
Total bilirubin is less than 2 x the upper limit of normal.
You have a left ventricular ejection fraction (LVEF) >45%.
You have negative HIV serology.\n

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 12th, 2021

Last Reviewed: November 13th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.