Clinical trial · Interventional
Loratadine for the Reduction of G-CSF Induced Bone Pain in Patients With Multiple Myeloma Undergoing Stem Cell Mobilization
The Prophylactic Use of Loratadine for Granulocyte-Colony Stimulating Factor (G-CSF) Induced Bone Pain in Multiple Myeloma Patients Undergoing Stem Cell Mobilization
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This early phase I trial studies how well loratadine works in reducing granulocyte-colony stimulating factor (G-CSF) induced bone pain in patients with multiple myeloma who are undergoing stem cell mobilization. Loratadine is an antihistamine that may help to reduce or control bone pain during the process of stem cell collection in patients with multiple myeloma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Plasma Cell Myeloma | Multiple Myeloma | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Loratadine | Drug | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cohort I (loratadine)
- description
- Beginning 5 days before the first dose of standard of care filgrastim, patients receive loratadine PO QD. Treatment continues until 5 days after completion of stem cell mobilization in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: Loratadine
- Other: Questionnaire Administration
- type
- PLACEBO_COMPARATOR
- label
- Cohort II (placebo)
- description
- Beginning 5 days before the first dose of standard of care filgrastim, patients receive placebo PO QD. Treatment continues until 5 days after completion of stem cell mobilization in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Other: Placebo
- Other: Questionnaire Administration
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient must be able to provide informed consent * Patients with confirmed diagnosis of multiple myeloma * Able to swallow and retain oral medication * All ethnic groups are eligible Exclusion Criteria: * Non-English speaking person * Patients undergoing haploidentical allogeneic hematopoietic stem cell transplant * Known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds * Any medical complications or conditions that would, in the investigator's judgement, interfere with full participation in the study * On therapeutic dose of aspirin (doses greater than 81 mg) within 7 days prior to the start of the study
References
Publications (0)
Data not yet available