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

Sponsor
Albert Einstein College of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT01899326
Collaborator
National Cancer Institute (NCI) (NIH)
9
Enrollment
1
Location
1
Arm
73
Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Desipramine Hydrochloride
  • Biological: Filgrastim
  • Other: Laboratory Biomarker Analysis
 N/A

Detailed Description

PRIMARY OBJECTIVES:

  1. 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).

  2. 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
9 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Pilot Clinical Study of GCSF in Combination With Desipramine for Autologous Stem Cell Mobilization in Multiple Myeloma
Study Start Date :
Dec 1, 2012
Actual Primary Completion Date :
Mar 1, 2015
Actual Study Completion Date :
Jan 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment (desipramine, filgrastim)

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.

Drug: Desipramine Hydrochloride
Given PO
Other Names:
  • Norpramin
  • Pertofrane

    • Biological: Filgrastim
    Given PO
    Other Names:
  • G-CSF
  • Nivestim
  • r-metHuG-CSF

    • Other: Laboratory Biomarker Analysis
    Correlative studies

    Outcome Measures

    Primary Outcome Measures

    1. 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 [Day 5]

      Standard descriptive statistics will be used to summarize the data, including means, medians, standard deviations and ranges for continuous variables, and frequencies for categorical variables. The success rates observed in first-time mobilizers, along with corresponding 95% binomial confidence intervals, will be estimated.

    2. 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 [Day 5]

      Standard descriptive statistics will be used to summarize the data, including means, medians, standard deviations and ranges for continuous variables, and frequencies for categorical variables. The success rates observed in predicted difficult mobilizers, along with corresponding 95% binomial confidence intervals, will be estimated.

    Secondary Outcome Measures

    1. Average number of days of apheresis required to collect > 5 x 10^6 CD34+/kg [Up to 1 week after completion of study treatment]

      Standard descriptive statistics will be used to summarize the data, including means, medians, standard deviations and ranges for continuous variables, and frequencies for categorical variables.

    2. Incidence of adverse events graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4 [Up to 1 week after completion of study treatment]

      Standard descriptive statistics will be used to summarize the data, including means, medians, standard deviations and ranges for continuous variables, and frequencies for categorical variables.

    3. 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 [Up to 1 week after completion of study treatment]

      Standard descriptive statistics will be used to summarize the data, including means, medians, standard deviations and ranges for continuous variables, and frequencies for categorical variables.

    4. Time to platelet engraftment: first of three days of platelets > 20,000/ul without transfusion [Up to 1 week after completion of study treatment]

      Standard descriptive statistics will be used to summarize the data, including means, medians, standard deviations and ranges for continuous variables, and frequencies for categorical variables.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Albert Einstein College of Medicine Bronx New York United States 10461

    Sponsors and Collaborators

    • Albert Einstein College of Medicine
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Murali Janakiram, Albert Einstein College of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Albert Einstein College of Medicine
    ClinicalTrials.gov Identifier:
    NCT01899326
    Other Study ID Numbers:
    • 2012-230
    • NCI-2013-01212
    • 11-010
    • 2012-230
    • P30CA013330
    First Posted:
    Jul 15, 2013
    Last Update Posted:
    Dec 12, 2019
    Last Verified:
    Dec 1, 2019
    Additional relevant MeSH terms:
    Multiple Myeloma
    Neoplasms, Plasma Cell
    Desipramine

    Study Results

    No Results Posted as of Dec 12, 2019