Status:
COMPLETED
Phase I Study of Bortezomib With G-CSF for Stem Cell Mobilization in Patients With Multiple Myeloma
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
Millennium Pharmaceuticals, Inc.
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this research study is to determine the highest dose of a drug called bortezomib that can be given with a drug called G-CSF before stem cell collection to help in the mobilization of st...
Detailed Description
The purpose of this phase I study is to define the maximum tolerated dose of bortezomib and its mobilization effects when given with G-CSF for stem cell mobilization in multiple myeloma patients. We h...
Eligibility Criteria
Inclusion
- Histologically confirmed diagnosis of multiple myeloma.
- Eligible for autologous transplantation.
- Received at least two cycles of any regimen as initial systemic therapy for multiple myeloma and are within 2-12 months of the first dose of initial therapy.
- At least 18 years of age.
- ECOG performance status ≤ 2
- Normal bone marrow and organ function as defined below:
- Platelets ≥ 50,000/mm3
- Hemoglobin ≥ 8.0 g/dL
- Absolute neutrophil count ≥1,000/mm3
- AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN
- Total bilirubin ≤ 1.5 x IULN
- Measured or calculated creatinine clearance ≥ 30 mL/min
- Female patients who:
- are postmenopausal for at least 1 year before the screening visit OR
- are surgically sterile OR
- Women of childbearing potential and men must agree to practice 2 effective methods of contraception prior to study entry, for the duration of study participation, and for 30 days after the last dose of study treatment. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
- Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
Exclusion
- Previous stem cell collection or transplantation (autologous or allogeneic).
- Evidence of multiple myeloma disease progression (as defined by IMWG) any time prior to auto-HSCT.
- Diagnosis of plasma cell leukemia.
- Concurrent hematologic or non-hematologic malignancy requiring treatment (other than multiple myeloma or secondary amyloidosis).
- Radiation therapy within 3 weeks prior to enrollment.
- Grade 2 or higher peripheral neuropathy.
- Known hypersensitivity to any of the following: bortezomib, boron, mannitol.
- Myocardial infarction within 6 months prior to enrollment or New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, or serious medical or psychiatric illness/social situations that would limit compliance with study requirements.
- Female patients who are pregnant and/or breastfeeding. Patient must have a negative serum pregnancy test within 14 days of study entry.
- Known HIV-positivity. These patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients with HIV-positivity when indicated.
- Participation in clinical trials with other investigational agents not included in this trial, within 14 days of the start of the trial and throughout the duration of the trial
Key Trial Info
Start Date :
February 20 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2016
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT02220608
Start Date
February 20 2015
End Date
November 30 2016
Last Update
January 8 2018
Active Locations (1)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110