Desipramine Hydrochloride and Filgrastim For Stem Cell Mobilization in Patients With Multiple Mye… (NCT01899326) | Clinical Trial Compass
TerminatedNot Applicable
Desipramine Hydrochloride and Filgrastim For Stem Cell Mobilization in Patients With Multiple Myeloma Undergoing Stem Cell Transplant
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.
United States10 participantsStarted 2013-09
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Success Rate of Stem Cell Mobilization (SCM) in Participants Who Completed Filgrastim and Desipramine Therapy
Timeframe: Day 5
2
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