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

NCT01899326 | Terminated Results DMC

• 4 other identifiers: 2012-230NCI-2013-0121211-010P30CA013330
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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.

  Day 5

• 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.

  Day 5

Secondary Outcomes (4)

• Median Number of Days of Apheresis

  Up to 1 week following completion of study treatment, up to 15 days

• Incidence of Adverse Events

  Up to 1 week following completion of study treatment, up to 15 days

• Median Time to Neutrophil Engraftment

  Up to 1 week following completion of study treatment, up to 15 days

• Median Time to Platelet Engraftment

  Up to 1 week following completion of study treatment, up to 15 days

Study Arms (1)

Treatment (desipramine, filgrastim)

EXPERIMENTAL

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.

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

Interventions

Desipramine Hydrochloride DRUG

Given PO

Also known as: Norpramin, Pertofrane

Treatment (desipramine, filgrastim)

Filgrastim BIOLOGICAL

Given PO

Also known as: G-CSF, Nivestim, r-metHuG-CSF

Treatment (desipramine, filgrastim)

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (desipramine, filgrastim)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Desipramine; Filgrastim; Granulocyte Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Limitations and Caveats

Target enrollment (n=20) was not reached. 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.

Results Point of Contact

• Title: Dr. Amit Verma
• Organization: Albert Einstein College of Medicine

amit.verma@einsteinmed.edu

718-430-4091

Study Officials

• Murali Janakiram

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 11, 2013
• First Posted: July 15, 2013
• Study Start: September 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: March 28, 2023
• Results First Posted: March 28, 2023

Record last verified: 2023-03

Locations

US (1)