Recruiting
Early Phase 1

Loratadine

Sponsor:

Rutgers, The State University of New Jersey

Code:

NCT04211259

Conditions

Plasma Cell Myeloma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Loratadine

Placebo

Questionnaire Administration

Study Details

Brief summary:

This early phase I trial studies how well loratadine works in reducing granulocyte-colony stimulating factor (G-CSF) induced bone pain in patients with multiple myeloma who are undergoing stem cell mobilization. Loratadine is an antihistamine that may help to reduce or control bone pain during the process of stem cell collection in patients with multiple myeloma.

Conditions

Plasma Cell Myeloma

Study ID

NCT04211259

Start date

Apr 18, 2022

Status verified date

May, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patient must be able to provide informed consent
  • Patients with confirmed diagnosis of multiple myeloma
  • Able to swallow and retain oral medication
  • All ethnic groups are eligible

Exclusion Criteria:

  • Non-English speaking person
  • Patients undergoing haploidentical allogeneic hematopoietic stem cell transplant
  • Known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds
  • Any medical complications or conditions that would, in the investigator's judgement, interfere with full participation in the study
  • On therapeutic dose of aspirin (doses greater than 81 mg) within 7 days prior to the start of the study

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort I (loratadine)

Beginning 5 days before the first dose of standard of care filgrastim, patients receive loratadine PO QD. Treatment continues until 5 days after completion of stem cell mobilization in the absence of disease progression or unacceptable toxicity.

placebo comparator: Cohort II (placebo)

Beginning 5 days before the first dose of standard of care filgrastim, patients receive placebo PO QD. Treatment continues until 5 days after completion of stem cell mobilization in the absence of disease progression or unacceptable toxicity.

Interventions

Loratadine

Given PO

Placebo

Given PO

Questionnaire Administration

Ancillary studies

Primary outcome measure

  • Change in mean pain level for each group following therapy [ Time Frame: Baseline up to 5 days after completion of stem cell mobilization ]

Central Contacts and Locations

Central contacts

Mansi R. Shah, MD

732-235-4439shahmr@cinj.rutgers.edu

Locations

Rutgers Cancer Institute of New Jersey

Recruiting

New Brunswick, New Jersey, United States, 08903

Contacts

Mansi R. Shah, MD

732-235-4439shahmr@cinj.rutgers.edu

Principal Investigator:

Mansi Shah

More Information

Sponsor

Rutgers, The State University of New Jersey

Last update posted

May 29, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rutgers, The State University of New Jersey on 2026-05-29.