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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
78
Loratadine is 2nd generation inverse agonist that exerts its effect by targeting H1 histamine receptors.
Placebo sugar pill
Cross Cancer Institute
Edmonton, Alberta, Canada
RECRUITINGBone 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).
Time frame: 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).
Time frame: 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).
Time frame: QLQ-BM22 will be completed at baseline and at the end of treatment (max day 12).
Stem cell mobilization efficacy
Normalized mean and absolute number number of stem cells collected at the end of the mobilization protocol
Time frame: 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.
Time frame: Single measurement during stem cell re-infusion (max day 8)
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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
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: Patients will be followed for 1 year after completion of the study treatment.