Loratadine for the Prevention of G-CSF-related Bone Pain

Launched by AHS CANCER CONTROL ALBERTA · Jun 13, 2022

Keywords

ClinConnect Summary

This clinical trial is studying whether a medication called loratadine can help prevent bone pain caused by a treatment known as G-CSF, which is often used during autologous stem cell transplants for patients with lymphoma or multiple myeloma. The researchers want to find out if loratadine is more effective than a placebo (a harmless dummy treatment) in reducing the pain that some patients experience during this process.

To be eligible for this trial, participants must be adults aged 18 or older who have a confirmed diagnosis of lymphoma or multiple myeloma and are scheduled to receive a stem cell transplant. They should not have any serious health issues that could complicate their participation. If you join the study, you will either receive loratadine or a placebo, and your experience will be monitored to see how well the treatment works in preventing bone pain. It’s important to note that certain medications and health conditions may exclude someone from participating, so it's best to discuss this with your doctor to see if you qualify.

Gender

ALL

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