NCT01899326 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: NA
Status at capture: TERMINATED
Registry last update: 2023-03-28

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Success Rate of Stem Cell Mobilization (SCM) in Participants Who Completed Filgrastim and Desipramine Therapy

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outcome · POSTED

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

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outcome · POSTED

Median Number of Days of Apheresis

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outcome · POSTED

Incidence of Adverse Events

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outcome · POSTED

Median Time to Neutrophil Engraftment

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outcome · POSTED

Median Time to Platelet Engraftment

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

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
healthy Volunteers: false
maximum Age: 70 Years
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

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 Names
Drug: Desipramine Hydrochloride
Biological: Filgrastim
Other: Laboratory Biomarker Analysis
label
Treatment (desipramine, filgrastim)
type
EXPERIMENTAL

interventions

arm Group Labels
Treatment (desipramine, filgrastim)
description
Given PO
name
Desipramine Hydrochloride
other Names
Norpramin
Pertofrane
type
DRUG
arm Group Labels
Treatment (desipramine, filgrastim)
description
Given PO
name
Filgrastim
other Names
G-CSF
Nivestim
r-metHuG-CSF
type
BIOLOGICAL
arm Group Labels
Treatment (desipramine, filgrastim)
description
Correlative studies
name
Laboratory Biomarker Analysis
type
OTHER

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 10
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

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.
measure
Success Rate of Stem Cell Mobilization (SCM) in Participants Who Completed Filgrastim and Desipramine Therapy
time Frame
Day 5
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.
measure
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
time Frame
Day 5

secondary Outcomes

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.
measure
Median Number of Days of Apheresis
time Frame
Up to 1 week following completion of study treatment, up to 15 days
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).
measure
Incidence of Adverse Events
time Frame
Up to 1 week following completion of study treatment, up to 15 days
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.
measure
Median Time to Neutrophil Engraftment
time Frame
Up to 1 week following completion of study treatment, up to 15 days
description
Median time (number of days) to platelet engraftment was determined as first of three consecutive days with platelets \> 20,000/ul without transfusion.
measure
Median Time to Platelet Engraftment
time Frame
Up to 1 week following completion of study treatment, up to 15 days

Full 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.

Source references

Source notices and limitations

Discovery and provenance

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source url
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Preserved source evidence · Not medical advice