Status:
TERMINATED
Desipramine Hydrochloride and Filgrastim For Stem Cell Mobilization in Patients With Multiple Myeloma Undergoing Stem Cell Transplant
Lead Sponsor:
Albert Einstein College of Medicine
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
DS (Durie/Salmon) Stage I Plasma Cell Myeloma
DS Stage II Plasma Cell Myeloma
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
This pilot clinical trial studied how well desipramine hydrochloride and filgrastim worked for stem cell mobilization in participants with multiple myeloma (MM) undergoing stem cell transplant. Giving...
Detailed Description
PRIMARY OBJECTIVES: I. To study efficacy, safety, harvest kinetics and engraftment kinetics of participants undergoing autologous stem cell mobilization, mobilized with a combination of granulocyte c...
Eligibility Criteria
Inclusion
- Patients eligible for autologous stem cell transplant for multiple myeloma; planned use of filgrastim (GCSF) for stem cell mobilization
- 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
- Use of a monoamine oxidase inhibitor (MAO-I) during or within 2 weeks of desipramine therapy
- 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
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01899326
Start Date
September 1 2013
End Date
March 1 2015
Last Update
March 28 2023
Active Locations (1)
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1
Albert Einstein College of Medicine
The Bronx, New York, United States, 10461