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

Primary Purpose

DS (Durie/Salmon) Stage I Plasma Cell Myeloma, DS Stage II Plasma Cell Myeloma, DS Stage III Plasma Cell Myeloma

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Desipramine Hydrochloride
Filgrastim
Laboratory Biomarker Analysis
Sponsored by
Albert Einstein College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for DS (Durie/Salmon) Stage I Plasma Cell Myeloma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Albert Einstein College of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (desipramine, filgrastim)

Arm 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.

Outcomes

Primary Outcome Measures

Success Rate of Stem Cell Mobilization (SCM) in Participants Who Completed Filgrastim and Desipramine Therapy
Success rate was assessed as the number of participants with Multiple Myeloma (MM) who were first time mobilizers or unexposed to alkylating agents who completed the full course of filgrastim and desipramine and achieved the target collection of >=5 x 10^6 CD34+ cells/kg.
Success Rate of Stem Cell Mobilization (SCM) in Participants Who Failed Prior Mobilization or Who Were Exposed to Alkylator Therapy or Who Were Predicted to be Difficult to Mobilize Who Completed Filgrastim and Desipramine Therapy
Success rate was assessed as the number of participants with Multiple Myeloma (MM) who Failed Prior Mobilization or who were Exposed to Alkylator Therapy or who were Predicted to be Difficult to Mobilize who completed the full course of filgrastim and desipramine and achieved the target collection of >=5 x 10^6 CD34+ cells/kg.

Secondary Outcome Measures

Median Number of Days of Apheresis
Median number of days of apheresis required to collect >=5 x 10^6 CD34+ cells/kg. Standard descriptive statistics were used to summarize the data.
Incidence of Adverse Events
Incidence of adverse events up to 1 week following completion of study treatment. Adverse events were graded using Version 4.0 of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE).
Median Time to Neutrophil Engraftment
Median time (number of days) to neutrophil engraftment was determined as 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.
Median Time to Platelet Engraftment
Median time (number of days) to platelet engraftment was determined as first of three consecutive days with platelets > 20,000/ul without transfusion.

Full Information

First Posted
July 11, 2013
Last Updated
March 2, 2023
Sponsor
Albert Einstein College of Medicine
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01899326
Brief Title
Desipramine Hydrochloride and Filgrastim For Stem Cell Mobilization in Patients With Multiple Myeloma Undergoing Stem Cell Transplant
Official Title
Pilot Clinical Study of GCSF in Combination With Desipramine for Autologous Stem Cell Mobilization in Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Terminated
Why Stopped
The study was stopped during the interim analysis due to low accrual after the widespread use of plerixafor for multiple myeloma in the United States.
Study Start Date
September 2013 (Actual)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Albert Einstein College of Medicine
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
DS (Durie/Salmon) Stage I Plasma Cell Myeloma, DS Stage II Plasma Cell Myeloma, DS Stage III Plasma Cell Myeloma, Refractory Plasma Cell Myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (desipramine, filgrastim)
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Desipramine Hydrochloride
Other Intervention Name(s)
Norpramin, Pertofrane
Intervention Description
Given PO
Intervention Type
Biological
Intervention Name(s)
Filgrastim
Other Intervention Name(s)
G-CSF, Nivestim, r-metHuG-CSF
Intervention Description
Given PO
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Success Rate of Stem Cell Mobilization (SCM) in Participants Who Completed Filgrastim and Desipramine Therapy
Description
Success rate was assessed as the number of participants with Multiple Myeloma (MM) who were first time mobilizers or unexposed to alkylating agents who completed the full course of filgrastim and desipramine and achieved the target collection of >=5 x 10^6 CD34+ cells/kg.
Time Frame
Day 5
Title
Success Rate of Stem Cell Mobilization (SCM) in Participants Who Failed Prior Mobilization or Who Were Exposed to Alkylator Therapy or Who Were Predicted to be Difficult to Mobilize Who Completed Filgrastim and Desipramine Therapy
Description
Success rate was assessed as the number of participants with Multiple Myeloma (MM) who Failed Prior Mobilization or who were Exposed to Alkylator Therapy or who were Predicted to be Difficult to Mobilize who completed the full course of filgrastim and desipramine and achieved the target collection of >=5 x 10^6 CD34+ cells/kg.
Time Frame
Day 5
Secondary Outcome Measure Information:
Title
Median Number of Days of Apheresis
Description
Median number of days of apheresis required to collect >=5 x 10^6 CD34+ cells/kg. Standard descriptive statistics were used to summarize the data.
Time Frame
Up to 1 week following completion of study treatment, up to 15 days
Title
Incidence of Adverse Events
Description
Incidence of adverse events up to 1 week following completion of study treatment. Adverse events were graded using Version 4.0 of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE).
Time Frame
Up to 1 week following completion of study treatment, up to 15 days
Title
Median Time to Neutrophil Engraftment
Description
Median time (number of days) to neutrophil engraftment was determined as 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 following completion of study treatment, up to 15 days
Title
Median Time to Platelet Engraftment
Description
Median time (number of days) to platelet engraftment was determined as first of three consecutive days with platelets > 20,000/ul without transfusion.
Time Frame
Up to 1 week following completion of study treatment, up to 15 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Murali Janakiram
Organizational Affiliation
Albert Einstein College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Albert Einstein College of Medicine
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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