Using loratadine to prevent bone pain from G-CSF during stem cell transplants

Loratadine for the Prevention of Bone Pain Caused by Granulocyte Colony Stimulating Factor (G-CSF) During Stem Cell Mobilization

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: PHASE2
• Study type: Interventional
• Enrollment: 78 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: AHS Cancer Control Alberta (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Edmonton, Alberta)
• Trial ID: NCT05421416 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with lymphoma or multiple myeloma who are scheduled for an autologous stem cell transplant.

Not a fit: Patients with hypersensitivity to antihistamines or those who have recently used G-CSF may not benefit from this study.

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 performed: 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.

Eligibility 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 this trial is running

Edmonton, Alberta

• Cross Cancer Institute — Edmonton, Alberta, Canada (RECRUITING)

Study contacts

• Study coordinator: Michael Chu, MD

Conditions: Stem Cell Transplant Complications