Using loratadine to reduce bone pain from G-CSF in multiple myeloma patients during 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
This study is testing if taking loratadine can help reduce bone pain in multiple myeloma patients who are receiving G-CSF during stem cell collection.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rutgers, The State University of New Jersey Academic / other |
| Locations | 2 sites (New Brunswick, New Jersey and 1 other locations) |
| Trial ID | NCT04211259 on ClinicalTrials.gov |
What this trial studies
This early phase I trial investigates the effectiveness of loratadine, an antihistamine, in alleviating bone pain caused by granulocyte-colony stimulating factor (G-CSF) in patients with multiple myeloma undergoing stem cell mobilization. Participants are randomly assigned to receive either loratadine or a placebo starting five days before G-CSF treatment and continuing until five days after stem cell collection. The study aims to evaluate the efficacy of loratadine and assess the need for additional pain relief medications. Additionally, it seeks to identify risk factors for developing G-CSF induced bone pain.
Who should consider this trial
Good fit: Ideal candidates include patients with a confirmed diagnosis of multiple myeloma who are able to take oral medications.
Not a fit: Patients who are non-English speaking or have known allergies to the study medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new method for managing bone pain in multiple myeloma patients during stem cell mobilization.
How similar studies have performed: While this approach is novel in the context of G-CSF induced bone pain, similar studies using antihistamines for pain management have shown promise.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
New Brunswick, New Jersey and 1 other locations
- Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States (Recruiting)
- RWJBarnabas Health - Robert Wood Johnson University Hospital, New Brunswick — New Brunswick, New Jersey, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Mansi R. Shah, MD — Rutgers Cancer Institute of New Jersey
- Study coordinator: Mansi R. Shah, MD
- Email: shahmr@cinj.rutgers.edu
- Phone: 732-235-4439
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.