Using loratadine to prevent bone pain from G-CSF during stem cell transplants
Official title: Loratadine for the Prevention of Bone Pain Caused by Granulocyte Colony Stimulating Factor (G-CSF) During Stem Cell Mobilization
Run by AHS Cancer Control Alberta · NCT05421416 · Data updated 2026-11-12
This study is testing if loratadine can help prevent bone pain in adults with lymphoma or multiple myeloma who are getting stem cell transplants.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 78 (estimated) |
| Sponsor | AHS Cancer Control Alberta Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Edmonton, Alberta) |
| Status | Recruiting |
| Started | November 28, 2024 |
| Main results expected | December 1, 2026 |
| Study ends | December 1, 2026 |
| Registry record updated | February 5, 2026 |
| Trial ID | NCT05421416 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with lymphoma or multiple myeloma who are scheduled for an autologous stem cell transplant.
✕Probably not a fit
Patients with hypersensitivity to antihistamines or those who have recently used G-CSF may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates whether loratadine is more effective than a placebo in preventing bone pain associated with G-CSF during autologous hematopoietic stem cell transplants in patients with lymphoma or multiple myeloma. The trial will involve adult participants who meet specific eligibility criteria, including a documented diagnosis of lymphoma or multiple myeloma and the need for a stem cell transplant. Participants will be randomly assigned to receive either loratadine or a placebo, and the severity of bone pain will be monitored throughout the treatment period.
Why it matters
Potential benefit: If successful, this study could provide a new method to alleviate bone pain for patients undergoing stem cell transplants.
How similar studies have gone: While similar studies have explored pain management in stem cell transplant patients, the specific use of loratadine for G-CSF-related bone pain is a novel approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. A histologically or cytologically documented lymphoma or multiple myeloma 2. Next line of therapy is autologous stem cell transplant 3. Adult ≥ 18 years old. 4. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2. 5. Life expectancy of at least 12 weeks. 6. The absence of any additional poorly controlled systemic disease that is directly contraindicated or places subject at significant risk, including but not limited to: congestive heart failure, diabetes mellitus, cirrhosis or liver failure, renal failure. 7. Able to adhere to study protocols and visit schedules Exclusion Criteria: 1. Hypersensitivity or intolerance to antihistamines 2. Use of antihistamines within two days prior to the study period, excepting the use of single dose antihistamines during chemotherapy or blood transfusion protocols. 3. Recent use of G-CSF or pegfilgrastim defined as within 12 weeks of study accrual. 4. New and continued regular use of analgesics within the four days prior to the first dose of G-CSF
Where it's running
-
Cross Cancer Institute
Edmonton, Alberta, Canada Recruiting
Study contacts
- Study coordinator: Michael Chu, MD
- Email: Michael.Chu@ahs.ca
- Phone: 780-432-8757
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Combining ruxolitinib with corticosteroids for severe acute graft‑versus‑host disease
This trial tests whether adding ruxolitinib to corticosteroids as first‑line treatment helps people who develop severe acute graft‑versus‑host disease after a first stem cell transplant.
-
Venetoclax added to reduced-intensity conditioning for combined stem cell and kidney transplant
This trial tests whether adding venetoclax to a reduced-intensity conditioning regimen is safe for adults with blood cancers who are receiving a combined stem cell and kidney transplant from a matched or partially matched donor.
-
First-line ruxolitinib plus corticosteroids for grade II acute graft-versus-host disease
This trial will test whether adding ruxolitinib to standard corticosteroids helps people with new grade II acute graft-versus-host disease after an allogeneic stem cell transplant.
-
Individualized ATG dosing for stem cell transplantation
This study is testing a personalized approach to dosing a medication for adults receiving stem cell transplants to see if it can reduce complications like infections and improve recovery.
-
Digital application to improve sexual health for stem cell transplant survivors
This study is testing a new app to help survivors of stem cell transplants improve their sexual health and overall well-being.
-
Modified second transplantation for patients with graft failure
This study is testing a new approach to a second stem cell transplant for patients who didn't fully recover after their first transplant to see if it helps them get better, especially with their platelet counts.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.