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NCT Number: NCT05421416

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

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.

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Key information

Conditions

Stem Cell Transplant Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Loratadine

Drug

Loratadine is 2nd generation inverse agonist that exerts its effect by targeting H1 histamine receptors.

Placebo

Drug

Placebo sugar pill

Primary outcomes

  1. Bone Pain Severity (Brief Pain Inventory)

    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).

    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).

  2. Bone Pain Interference (Brief Pain Inventory)

    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).

    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).

  3. Bone pain severity (QLQ-BM22)

    Time frame: QLQ-BM22 will be completed at baseline and at the end of treatment (max day 12).

    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).

Secondary outcomes

  1. Stem cell mobilization efficacy

    Time frame: Single measurement at the end of mobilization protocol (max day 8)

    Normalized mean and absolute number number of stem cells collected at the end of the mobilization protocol

  2. Mean time to stem cell re-engraftment

    Time frame: Single measurement during stem cell re-infusion (max day 8)

    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.

  3. Rate of plerixafor use during in each study arm

    Time frame: Single measurement after all patients have completed end of treatment.

    Proportion of patients in each study arm that require use of plerixafor during stem cell mobilization

  4. Rate of pain control use

    Time frame: Single measurement after all patients complete mobilization (max day 8)

    Proportion of patients in each study arm that require use of additional pain control methods while receiving G-CSF.

  5. Qualitative breakthrough of pain control use

    Time frame: Qualitative description of analgesic type after all patients complete mobilization (max day 8)

    Type of medication used to control additional pain while receiving G-CSF.

  6. Progression free survival

    Time frame: Patients will be followed for 1 year after completion of the study treatment.

    Time between the date of treatment initiation and the date of disease progression or death (whatever the cause), whichever occurs first)

Study contacts

Contact information is provided by the study sponsor or research team.

Michael Chu, MD

CONTACT

[email protected]

780-432-8757

Rammy Khadour

CONTACT

[email protected]

780-432-8795

Sponsors and collaborators

Lead sponsor

AHS Cancer Control Alberta

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 16, 2022
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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