70 Participants Needed

Loratadine for Bone Pain in Multiple Myeloma

Recruiting at 1 trial location
MR
Overseen ByMansi R. Shah, MD
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: Rutgers, The State University of New Jersey
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

This trial studies if loratadine, an allergy medicine, can reduce bone pain in multiple myeloma patients who are collecting stem cells. These patients often experience pain from a drug called filgrastim, and loratadine might help ease this pain. Loratadine has been considered for managing bone pain induced by certain medications.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot be on a therapeutic dose of aspirin (more than 81 mg) within 7 days before starting the study.

Is loratadine safe for humans?

Loratadine, also known as Claritin, has been evaluated for safety in various conditions like allergic rhinitis, hay fever, and chronic idiopathic urticaria. Studies show it is generally well-tolerated, with no significant sedative or anticholinergic (dry mouth) side effects compared to placebo.12345

How does the drug loratadine differ from other treatments for bone pain in multiple myeloma?

Loratadine is unique because it is primarily an antihistamine used for allergies, but it is being explored for bone pain in multiple myeloma, which is not a typical use for antihistamines. Its potential advantage is that it is non-sedating and has a fast onset of action, which might offer relief without the drowsiness associated with other pain medications.15678

Research Team

MR

Mansi R. Shah, MD

Principal Investigator

Rutgers Cancer Institute of New Jersey

Eligibility Criteria

This trial is for people with multiple myeloma who can consent, swallow pills, and belong to any ethnic group. It's not for non-English speakers, those allergic to study drugs or similar compounds, on high-dose aspirin recently, or having conditions that could limit full participation.

Inclusion Criteria

I can swallow and keep down pills.
Patient must be able to provide informed consent
I have been diagnosed with multiple myeloma.
See 1 more

Exclusion Criteria

I have taken more than 81 mg of aspirin daily in the week before the study starts.
I am getting a stem cell transplant from a partially matched donor.
Known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive loratadine or placebo starting 5 days before the first dose of filgrastim and continue until 5 days after completion of stem cell mobilization

Approximately 2 weeks
Daily oral administration

Follow-up

Participants are monitored for changes in pain levels and safety after treatment

5 days

Treatment Details

Interventions

  • Loratadine
Trial OverviewThe trial tests if Loratadine reduces bone pain caused by G-CSF during stem cell mobilization in multiple myeloma patients. Participants will either receive Loratadine or a placebo while their responses are monitored through questionnaires.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Cohort I (loratadine)Experimental Treatment2 Interventions
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.
Group II: Cohort II (placebo)Placebo Group2 Interventions
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.

Loratadine is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Loratadine for:
  • Allergic rhinitis
  • Urticaria
🇪🇺
Approved in European Union as Loratadine for:
  • Allergic rhinitis
  • Urticaria
🇨🇦
Approved in Canada as Loratadine for:
  • Allergic rhinitis
  • Urticaria

Find a Clinic Near You

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials
471
Recruited
81,700+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Findings from Research

In a study involving 107 hay fever patients, loratadine (40 mg once daily) was found to significantly reduce allergy symptoms compared to placebo, outperforming clemastine (1 mg twice daily) in effectiveness.
Loratadine did not cause sedation, while clemastine had a higher sedation rate, making loratadine a safer option for treating hay fever without the drowsiness associated with some antihistamines.
Treatment of hay fever with loratadine--a new non-sedating antihistamine.Irander, K., Odkvist, LM., Ohlander, B.[2019]
A study involving 40 elderly patients (ages 50 to 88) with allergic rhinitis found that loratadine, taken at a dose of 10 mg daily for 30 days, did not cause any changes in heart rhythm or significant alterations in ECG parameters, indicating its cardiac safety.
The results showed no significant prolongation of the QT interval, suggesting that loratadine is safe for long-term use in elderly patients, even those with a history of cardiovascular issues.
[Cardiac safety evaluation of loratadine in the treatment of allergic rhinitis in elderly patients].Liu, Y., Cheng, L.[2013]
A systematic review of 11 randomized controlled trials involving 317 children showed that loratadine significantly improved asthma symptoms and lung function (FEV1 and PEFR) compared to a control group.
Loratadine was associated with fewer treatment-related side effects, such as fatigue and tachycardia, indicating it is a safe option for managing childhood asthma.
[Evaluation of efficacy and safety of loratadine in the treatment of childhood asthma].Maimaiti, G., Abduhaer, A., Xu, PR.[2018]

References

Treatment of hay fever with loratadine--a new non-sedating antihistamine. [2019]
[Cardiac safety evaluation of loratadine in the treatment of allergic rhinitis in elderly patients]. [2013]
[Evaluation of efficacy and safety of loratadine in the treatment of childhood asthma]. [2018]
Comparative effects of loratadine and terfenadine in the treatment of chronic idiopathic urticaria. [2013]
[Allergic bronchial asthma treated with Loratadine]. [2013]
Loratadine. A reappraisal of its pharmacological properties and therapeutic use in allergic disorders. [2018]
A multicentre study of loratadine, clemastine and placebo in patients with perennial allergic rhinitis. [2019]
Loratadine and desethoxylcarbonyl-loratadine inhibit the immunological release of mediators from human Fc epsilon RI+ cells. [2019]