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

NCT05421416 | Recruiting Phase 2 DMC

• 1 other identifier: IIT-0020
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stem Cell Transplant Complications

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Stem cell mobilization efficacy

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

• Mean time to stem cell re-engraftment

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

• Rate of plerixafor use during in each study arm

  Single measurement after all patients have completed end of treatment.

• Rate of pain control use

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

• Qualitative breakthrough of pain control use

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

Study Arms (2)

Loratadine Arm

EXPERIMENTAL

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

Placebo Arm

PLACEBO COMPARATOR

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

Interventions

Loratadine DRUG

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

Loratadine Arm

Placebo DRUG

Placebo sugar pill

Placebo Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AHS Cancer Control Alberta: lead

Study Sites (1)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

RECRUITING

MeSH Terms

Interventions

Loratadine

Intervention Hierarchy (Ancestors)

Cyproheptadine; Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Central Study Contacts

Michael Chu, MD

CONTACT

780-432-8757; Michael.Chu@ahs.ca

Rammy Khadour

CONTACT

780-432-8795; Rammy.Khadour@ahs.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2022
• First Posted: June 16, 2022
• Study Start: November 28, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-02

Locations

CA (1)