Loratadine for the Reduction of G-CSF Induced Bone Pain in Patients With Multiple Myeloma Undergoing Stem Cell Mobilization

Part of paid clinical trials in New Brunswick, New Jersey.

Sponsor
Rutgers, The State University of New Jersey
Study ID
NCT04211259
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Plasma Cell Myeloma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Loratadine — DRUG
    Given PO
  • Placebo — OTHER
    Given PO
  • Questionnaire Administration — OTHER
    Ancillary studies

Study Details

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.

Key Dates

Start date
Apr 18, 2022
Status verified
May 2026
Primary completion
Aug 31, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

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

Locations (2)

FacilityCityStateZIPSite coordinators
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08903
Mansi R. Shah, MD
[email protected]
732-235-4439
Mansi Shah (PRINCIPAL_INVESTIGATOR)
RWJBarnabas Health - Robert Wood Johnson University Hospital, New BrunswickNew BrunswickNew Jersey08903-

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By research site
Rutgers Cancer Institute of New Jersey· New Brunswick, NJRWJBarnabas Health - Robert Wood Johnson University Hospital, New Brunswick· New Brunswick, NJ

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