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About
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 colony-stimulating factors, such as filgrastim, and other drugs, such as desipramine hydrochloride, helps stem cells move from the participant's bone marrow to the blood so they can be collected and stored.
Full 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 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.
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Inclusion criteria
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:
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10 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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