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

Study Overview
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Brief Summary
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The research question for the current study is: Is loratadine more effective than placebo in preventing G-CSF-related bone pain during autologous hematopoetic stem cell transplant in patients with lymphoma or multiple myeloma? The hypothesis is that prophylaxis with loratadine will help prevent or reduce the severity of bone pain in this setting.

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

Conditions
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Stem Cell Transplant Complications

Intervention / Treatment
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* Drug: Loratadine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A histologically or cytologically documented lymphoma or multiple myeloma Next line of therapy is autologous stem cell transplant Adult ≥ 18 years old. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2. Life expectancy of at least 12 weeks. 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. Able to adhere to study protocols and visit schedules Exclusion Criteria: Hypersensitivity or intolerance to antihistamines Use of antihistamines within two days prior to the study period, excepting the use of single dose antihistamines during chemotherapy or blood transfusion protocols. Recent use of G-CSF or pegfilgrastim defined as within 12 weeks of study accrual. New and continued regular use of analgesics within the four days prior to the first dose of G-CSF

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Loratadine Arm<br>Loratadine 10mg, administered initially 3 hours before the first dose of G-CSF in the autologous stem cell mobilization protocol, and then daily for a minimum of 8 days. | Drug: Loratadine<br>* Loratadine is 2nd generation inverse agonist that exerts its effect by targeting H1 histamine receptors.<br>|
| Placebo Comparator: Placebo Arm<br>Placebo capsule, administered initially 3 hours before the first dose of G-CSF in the autologous stem cell mobilization protocol, and then daily for a minimum of 8 days. | Drug: Placebo<br>* Placebo sugar pill<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone Pain Severity (Brief Pain Inventory) | Reduction in bone pain will be measured as a change from pre-G-CSF baseline in the Brief Pain Inventory (BPI), with median values compared for each trial arm. BPI pain severity will be compared as a composite score (sum of individual pain values divided by 4). | Brief Pain Inventory will be completed at baseline, daily during treatment (up to 12 days) and at the end of treatment (max day 12). | 
| Bone Pain Interference (Brief Pain Inventory) | Reduction on impact on daily life as a composite score out of 10 as measured on the Brief Pain Inventory (BPI). BPI pain interference will be compared as a composite score (sum of individual pain interference values divided by 7). | Brief Pain Inventory will be completed at baseline, daily during treatment (up to 12 days) and at the end of treatment (max day 12). | 
| Bone pain severity (QLQ-BM22) | Change in bone pain measured pre and post G-CSF in EORTC QLQ-BM22. QLQ-BM22 questionnaires will be compared to the post vs pre-treatment values and calculated as a composite sum (i.e. pre-treatment total score subtracted from post-treatment total score). | QLQ-BM22 will be completed at baseline and at the end of treatment (max day 12). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stem cell mobilization efficacy | Normalized mean and absolute number number of stem cells collected at the end of the mobilization protocol | Single measurement at the end of mobilization protocol (max day 8) | 
| Mean time to stem cell re-engraftment | Time in days between stem cell re-infusion and the measurement on complete blood count (CBC) of an absolute neutrophil count of greater than 500/mm3 for 3 consecutive days. | Single measurement during stem cell re-infusion (max day 8) | 
| Rate of plerixafor use during in each study arm | Proportion of patients in each study arm that require use of plerixafor during stem cell mobilization | Single measurement after all patients have completed end of treatment. | 
| Rate of pain control use | Proportion of patients in each study arm that require use of additional pain control methods while receiving G-CSF. | Single measurement after all patients complete mobilization (max day 8) | 
| Qualitative breakthrough of pain control use | Type of medication used to control additional pain while receiving G-CSF. | Qualitative description of analgesic type after all patients complete mobilization (max day 8) | 
| Progression free survival | Time between the date of treatment initiation and the date of disease progression or death (whatever the cause), whichever occurs first) | Patients will be followed for 1 year after completion of the study treatment. |