Desipramine Hydrochloride and Filgrastim For Stem Cell Mobilization in Patients With Multiple Myeloma Undergoing Stem Cell Transplant

• Status: Completed
• Trial end date: 2019-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Albert Einstein College of Medicine; Albert Einstein College of Medicine of Yeshiva University
• Collaborator: National Cancer Institute (NCI)
• Treatments: Desipramine; Lenograstim

Criteria

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