This trial is active, not recruiting.

Conditions ds stage i plasma cell myeloma, ds stage ii plasma cell myeloma, ds stage iii plasma cell myeloma, refractory plasma cell myeloma
Treatments desipramine hydrochloride, filgrastim, laboratory biomarker analysis
Sponsor Albert Einstein College of Medicine of Yeshiva University
Collaborator National Cancer Institute (NCI)
Start date December 2012
End date March 2015
Trial size 9 participants
Trial identifier NCT01899326, 11-010, 2012-230, NCI-2013-01212, P30CA013330


This pilot clinical trial studies how well desipramine hydrochloride and filgrastim works for stem cell mobilization in patients with multiple myeloma undergoing stem cell transplant. Giving colony-stimulating factors, such as filgrastim, and other drugs, such as desipramine hydrochloride, helps stem cells move from the patient's bone marrow to the blood so they can be collected and stored.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Patients receive desipramine hydrochloride PO daily on days -3 to +4 and filgrastim PO BID on days 1-4. Stem cell collection begins on day 6.
desipramine hydrochloride Norpramin
Given PO
filgrastim G-CSF
Given PO
laboratory biomarker analysis
Correlative studies

Primary Outcomes

Success rate of stem cell mobilization (SCM) using filgrastim and desipramine to collect > 5 x 10^6 cluster of differentiation (CD)34/kg in patients with multiple myeloma (MM) who are first time mobilizers or unexposed to alkylating agents
time frame: Day 5
Success rate of SCM using filgrastim and desipramine to achieve a total collection of > 5 x 10^6 CD34/kg in patients with MM who failed prior mobilization or were exposed to alkylator therapy or are predicted to be difficult to mobilize
time frame: Day 5

Secondary Outcomes

Average number of days of apheresis required to collect > 5 x 10^6 CD34+/kg
time frame: Up to 1 week after completion of study treatment
Incidence of adverse events graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4
time frame: Up to 1 week after completion of study treatment
Time to neutrophil engraftment: first of three consecutive days with absolute neutrophil count (ANC) > 500/ul or first day with ANC > 1000/ul in the absence of growth factor support
time frame: Up to 1 week after completion of study treatment
Time to platelet engraftment: first of three days of platelets > 20,000/ul without transfusion
time frame: Up to 1 week after completion of study treatment

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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: - 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: - 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

Additional Information

Official title Pilot Clinical Study of GCSF in Combination With Desipramine for Autologous Stem Cell Mobilization in Multiple Myeloma
Principal investigator Murali Janakiram
Description PRIMARY OBJECTIVES: I. To study efficacy, safety, harvest kinetics and engraftment kinetics of patients 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: Patients receive desipramine hydrochloride orally (PO) daily on days -3 to +4 and filgrastim PO twice daily (BID) on days 1-4. Stem cell collection begins on day 6. After completion of study treatment, patients are followed up 1 week after completion of stem cell collection.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Albert Einstein College of Medicine of Yeshiva University.