Clinical trial · Interventional
Desipramine Hydrochloride and Filgrastim For Stem Cell Mobilization in Patients With Multiple Myeloma Undergoing Stem Cell Transplant
Pilot Clinical Study of GCSF in Combination With Desipramine for Autologous Stem Cell Mobilization in Multiple Myeloma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): 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.
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| DS (Durie/Salmon) Stage I Plasma Cell Myeloma | — | UNRESOLVED | — |
| DS Stage III Plasma Cell Myeloma | — | UNRESOLVED | — |
| DS Stage II Plasma Cell Myeloma | — | UNRESOLVED | — |
| Refractory Plasma Cell Myeloma | Multiple Myeloma | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Desipramine Hydrochloride | Drug | — | UNRESOLVED |
| Filgrastim | Biological | Filgrastim | ALIAS |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (desipramine, filgrastim)
- 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.
- interventionNames
- Drug: Desipramine Hydrochloride
- Biological: Filgrastim
- Other: Laboratory Biomarker Analysis
Primary outcomes (2)
- measure
- Success Rate of Stem Cell Mobilization (SCM) in Participants Who Completed Filgrastim and Desipramine Therapy
- timeFrame
- Day 5
- 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 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available