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

Albert Einstein College of Medicine

Status: Terminated

Conditions: DS Stage III Plasma Cell Myeloma; Refractory Plasma Cell Myeloma; DS Stage II Plasma Cell Myeloma; DS (Durie/Salmon) Stage I Plasma Cell Myeloma

Treatments: Biological: Filgrastim; Other: Laboratory Biomarker Analysis; Drug: Desipramine Hydrochloride

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01899326

2012-230 (Other Identifier)

P30CA013330 (U.S. NIH Grant/Contract)

NCI-2013-01212 (Registry Identifier)

11-010

Details and patient eligibility

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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Treatment (desipramine, filgrastim)

Experimental group

Description:

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.

Treatment:

Drug: Desipramine Hydrochloride

Other: Laboratory Biomarker Analysis

Biological: Filgrastim