Bortezomib for Hematologic Neoplasms

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Henry Ford hospital, Detroit, MI
Hematologic Neoplasms+1 More
Bortezomib - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a combination of cyclophosphamide and bortezomib may help improve the success of haploidentical stem cell transplants.

See full description

Eligible Conditions

  • Hematologic Neoplasms
  • Haematological Malignancies

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Bortezomib will improve 1 primary outcome in patients with Hematologic Neoplasms. Measurement will happen over the course of within 30 days post transplant.

Day 30
engraftment rate

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Recipient - Chemotherapy Group
Hemoglobin (hgb)
100%
Nausea
90%
Injection site reaction
80%
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
80%
SGPT (ALT)
80%
Vomiting
80%
Neutrophils/granulocytes (ANC/AGC) for BMT
80%
Leukocytes (total WBC)
80%
SGOT (AST)
80%
Neutrophils/granulocytes (ANC/AGC)
70%
Creatinine
70%
Platelets
70%
Diarrhea (without colostomy)
70%
Lymphopenia
70%
Rash/desquamation
60%
Bone pain
60%
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutropenia
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
60%
Hypoxia
50%
Cough
50%
Neuropathy-sensory
50%
Dyspnea (shortness of breath)
40%
Catheter-related infection
40%
Pain - Other
40%
Leukocytes (total WBC) for BMT
40%
Hypoalbuminemia
40%
Hypocalcemia
40%
Stomatitis/pharyngitis (oral/pharyngeal mucositis)
40%
Bilirubin
40%
Hemorrhage/bleeding without grade 3 or 4 thrombocytopenia
30%
Constipation
30%
Hypophosphatemia
30%
Hyperglycemia
30%
Febrile neutropenia
30%
Alkaline phosphatase
30%
Hypotension
30%
Transfusion: pRBCs
30%
Diarrhea for BMT
30%
Anorexia
30%
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
20%
Sweating (diaphoresis)
20%
Hypertension
20%
Chest pain (non-cardiac and non-pleuritic)
20%
Metabolic-Other (Hyperbilirubinemia; hyperbilirubinemia r/t GVH)
20%
Urinary frequency/urgency
20%
Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)
20%
Rigors/chills
20%
Abdominal pain or cramping
20%
Edema
20%
Hypokalemia
20%
Rash/desquamation for BMT
20%
Flushing
20%
Transfusion: Platelets
10%
Salivary gland changes
10%
Infection without neutropenia, C-diff
10%
Infection: blood
10%
Dizziness/lightheadedness
10%
Allergic reaction/hypersensitivity (including drug fever)
10%
Insomnia
10%
Pigmentation changes (e.g., vitiligo)
10%
Pulmonary-Other (URI)
10%
Pleural effusion (non-malignant)
10%
Infection without neutropenia, wound
10%
Proteinuria
10%
Weight loss
10%
Infection w/out neutropenia, catheter related
10%
Mood alteration-euphoria
10%
Injection site reaction, bilat arms
10%
Hypothyroidism
10%
Pericardial effusion/pericarditis
10%
Stomatitis/pharyngitis (oral/pharyngeal mucositis) for BMT
10%
Lymphatics-Other (Adenopathy)
10%
Infection without neutropenia, blood
10%
Myalgia (muscle ache)
10%
Vasovagal episode
10%
Injection site reaction, bilat legs
10%
Pruritus
10%
Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia
10%
Voice changes/stridor/larynx (e.g., hoarseness, loss of voice, laryngitis)
10%
Pneumonitis/pulmonary infiltrates
10%
Acidosis (metabolic or respiratory)
10%
Lymphatics
10%
Neuropathic pain
10%
Infection without neutropenia, Nasal Pharynx
10%
Joint, muscle, or bone (osseous)- Other (Calf cramping)
10%
Rectal bleeding/hematochezia
10%
Mood alteration::Depression
10%
Nausea and vomiting
10%
Constitutional Symptoms-Other (CGVHD-skin)
10%
Dyspareunia
10%
Erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis
10%
Hemoptysis
10%
Skin-Other (Drug reaction face, hands, neck)
10%
Thrombosis/embolism
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)
10%
Dry skin
0%
Hot flashes/flushes
0%
Hematologic-Other (Splenomegaly in donor-resolved)
0%
Hypercalcemia
0%
Arthralgia (joint pain)
0%
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%, Injection site reaction with 80%, Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) with 80%, SGPT (ALT) with 80%.

Trial Design

1 Treatment Group

Bortezomib
1 of 1
Experimental Treatment

This trial requires 15 total participants across 1 different treatment group

This trial involves a single treatment. Bortezomib is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Bortezomib
Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bortezomib
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: within 30 days post transplant
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly within 30 days post transplant for reporting.

Who is running the study

Principal Investigator
S. F.
Shatha Farhan, Principal Investigator
Henry Ford Health System

Closest Location

Henry Ford hospital - Detroit, MI

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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 Peripheral blood stem cells collection
Bilirubin </= 1.5 mg/dl , aspartate aminotransferase (AST) or alanine aminotransferase (ALT) </= 200 IU/ml for adults.
Serum creatinine clearance >/=60 ml/min (calculated with Cockroft-Gault formula)
Diffusing capacity for carbon monoxide (DLCO) >/= 45% predicted corrected for hemoglobin.
Left ventricle ejection fraction > 40%.
Patient or patient's legal representative, parent(s) or guardian should provide written informed consent.

Patient Q&A Section

What is hematologic neoplasms?

"While the disease burden of hematologic neoplasms is high, many patients are diagnosed with hematologic cancer at the end-of-life, resulting in increased mortality. Most patients are treated with hematologic-type cytotoxic agents, including tyrosine kinase inhibitors, allogeneic stem cell transplantation, and the immunomodulatory therapy interferon-alpha and lenalidomide. Many patients have nonhematologic-related causes of cancer at the time of diagnosis, resulting in substantial mortality but may not be treatable, such as cancer metastasis to bone marrow, liver, and lung." - Anonymous Online Contributor

Unverified Answer

Can hematologic neoplasms be cured?

"Hematological neoplasms are often cured with a number of standard chemotherapy regimens. For refractory or relapsed leukemia, new and intensifying chemotherapy regimens should be initiated if clinical benefit can be sustained." - Anonymous Online Contributor

Unverified Answer

How many people get hematologic neoplasms a year in the United States?

"There was a significantly higher incidence of hematologic neoplasms in the United States in 2011 than in 1990 (P <.001). The mean annual incidence of lymphoma in the United States had significantly increased since 1990." - Anonymous Online Contributor

Unverified Answer

What are the signs of hematologic neoplasms?

"Signs of hematologic neoplasms include low number of circulating blood cells due to anemia, or neutropenia due to neutrophilia or eosinophilia. Signs of a high circulating blood level of a hematological neoplasm can include a rapid increase in the level of the blood cell's constituent plasma protein (or anemia), or decreased blood platelet number. Other bleeding symptoms such as an easy bruising or nosebleed may appear due to platelet or coagulation disorders, or decreased number of red blood cells in circulation with anemia as a result." - Anonymous Online Contributor

Unverified Answer

What causes hematologic neoplasms?

"The majority of hematologic malignancies are caused by chemical exposures, viruses, chromosomal abnormalities, and autoimmune diseases. Many neoplasms are associated with aging and exposure to environmental agents. The carcinogen hypothesis proposes that environmental exposures are important factors in the causation of carcinoma." - Anonymous Online Contributor

Unverified Answer

What are common treatments for hematologic neoplasms?

"Treatment of hematologic neoplasms is largely based on the stage of the disease and the severity of the symptoms experienced. The treatment can be a combination of both chemotherapy and local therapies, particularly in localized cases of disease. Chemotherapy is usually given for multiple myeloma or leukemia. Local therapies may include radiotherapy or treatment with interferon-alpha for multiple myeloma." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of hematologic neoplasms?

"Causes of hematologic neoplasms include cancer, which is the most common type of hematologic neoplasm (38%), and inherited disorders, mainly genetic disorders (13%). [Power (http://www.withpower.com/hematologic-diseases/hereditary-disorders-hematological-diseases) can link to specific hereditary diseases and their associated mutations(http://geneva.gsa.gov/HGNC/mutations/qportal/).] Hematologic disorders are characterized by a high risk of new neoplasms and their associated symptoms. [Power(http://www.withpower." - Anonymous Online Contributor

Unverified Answer

How does bortezomib work?

"Bortezomib therapy in advanced hematological malignancies is associated with rapid, durable responses including complete responses and a reduced risk of serious adverse events. Bortezomib should be further studied in different clinical settings." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating hematologic neoplasms?

"In the past 2 decades, important new insights have been made in the treatment of hematopoietic neoplasms. In addition to conventional chemotherapy and the newly emerging therapeutic agents, targeted therapy including immunoassays and stem cell transplantation have become more valuable in treating hematological malignancies." - Anonymous Online Contributor

Unverified Answer

How quickly does hematologic neoplasms spread?

"Patients with acute leukemia tend to have large tumor masses, but the clinical stage, disease grade, and subtype seem to not be significantly associated with the spread rate, time spent in hospital, or clinical death rate. The study results reveal no correlation between survival outcomes or disease dissemination and the presence of B cell or T cell neoplasms." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in bortezomib for therapeutic use?

"Current developments aim at a better understanding of the mechanism responsible for tumor cell growth inhibition, aiming at the blockade of the proteasome-dependent cytotoxic activity of bortezomib itself and at the development of bortezomib analogues which display greater selectivity in the inactivation of the proteasome." - Anonymous Online Contributor

Unverified Answer

How serious can hematologic neoplasms be?

"In addition to the severity of the symptoms, clinical symptoms and hematologic values are not always related to the seriousness of the disease and only the type of pathogen affects the time of onset of disease. If the diagnosis is missed on the first admission, some of the cases can be saved by early diagnostic measures." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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