Desipramine Hydrochloride and Filgrastim For Stem Cell Mobilization in Patients With Multiple Myeloma Undergoing Stem Cell Transplant
NCT ID: NCT01899326
Last Updated: 2023-03-28
Study Results
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View full resultsBasic Information
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TERMINATED
NA
10 participants
INTERVENTIONAL
2013-09-30
2015-03-31
Brief Summary
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Detailed Description
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I. To study efficacy, safety, harvest kinetics and engraftment kinetics of participants undergoing autologous stem cell mobilization, mobilized with a combination of granulocyte colony-stimulating factor (GCSF) (filgrastim) with desipramine (desipramine hydrochloride) (G+D).
II. To analyze polymorphisms of adrenergic receptor beta 2 (ADRB2) and adrenergic receptor beta 3 (ADRB3) genes that correlate with mobilization efficiency.
OUTLINE:
Participants received desipramine hydrochloride orally (PO) daily on days -3 to +4 and filgrastim PO twice daily (BID) on days 1-4. Stem cell collection began on day 6.
After completion of study treatment, participants were followed up to 1 week after completion of stem cell collection.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (desipramine, filgrastim)
Participants received desipramine hydrochloride PO daily on days -3 to +4 and filgrastim PO BID on days 1-4. Stem cell collection began on day 6.
Desipramine Hydrochloride
Given PO
Filgrastim
Given PO
Laboratory Biomarker Analysis
Correlative studies
Interventions
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Desipramine Hydrochloride
Given PO
Filgrastim
Given PO
Laboratory Biomarker Analysis
Correlative studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Ability to give informed consent
* Glomerular filtration rate (GFR) \> 30 ml/minute
* Liver function tests \< 2.5 x upper limit of normal (ULN)
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 2 or less
* Based on prior therapy patients will be classified into two categories:
* Initial mobilizers with no exposure to alkylators
* Remobilizers or with prior exposure to alkylators or with greater than 5 cycles of lenalidomide therapy prior to mobilization
Exclusion Criteria
* Concomitant therapy with any drugs shown to have major interactions with desipramine
* Concurrent use of drugs that are contraindicated with desipramine
* Myocardial infarction in preceding 4 weeks; history of uncontrolled cardiac arrhythmias or family history of sudden cardiac death; baseline corrected QT (QTc) \> 460 msec
* Active alcohol abuse
* Bipolar disorder
* Untreated active major depression
* History of seizures in the past 3 years
* Pregnancy and lactation; refusal to use adequate contraception
* Uncontrolled thyroid disease
* GCSF or pegfilgrastim use within 14 days prior to enrollment
* Bortezomib, Revlimid or thalidomide use within 7 days of enrollment
* Patients with sickle cell disease
18 Years
70 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Albert Einstein College of Medicine
OTHER
Responsible Party
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Amit Verma
Principal Investigator
Principal Investigators
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Murali Janakiram
Role: PRINCIPAL_INVESTIGATOR
Albert Einstein College of Medicine
Locations
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Albert Einstein College of Medicine
The Bronx, New York, United States
Countries
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Other Identifiers
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NCI-2013-01212
Identifier Type: REGISTRY
Identifier Source: secondary_id
11-010
Identifier Type: -
Identifier Source: secondary_id
2012-230
Identifier Type: OTHER
Identifier Source: secondary_id
2012-230
Identifier Type: -
Identifier Source: org_study_id
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