Loratadine for Bone Pain in Multiple Myeloma
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen byDennis L Cooper
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase < 1
Recruiting
Sponsor: Rutgers, The State University of New Jersey
Must not be taking: Aspirin
Disqualifiers: Non-English speaking, Allergies, others
Approved in 3 Jurisdictions
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.
12345How 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.
25678Eligibility 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.
+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
+2 more
Trial 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
Participant Groups
The 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.
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
Research Locations NearbySelect from list below to view details:
Rutgers Cancer Institute of New JerseyNew Brunswick, NJ
RWJBarnabas Health - Robert Wood Johnson University Hospital, New BrunswickNew Brunswick, NJ
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Who Is Running the Clinical Trial?
Rutgers, The State University of New JerseyLead Sponsor
National Cancer Institute (NCI)Collaborator
References
[Cardiac safety evaluation of loratadine in the treatment of allergic rhinitis in elderly patients]. [2013]To evaluate the cardiac safety of the second-generation H1-antihistamine loratadine in the treatment of allergic rhinitis in elderly patients.
Treatment of hay fever with loratadine--a new non-sedating antihistamine. [2019]The efficacy and safety of loratadine, a new orally active specific H1-receptor blocking antihistamine with poor penetration into the CNS, was evaluated in a double blind comparative study. One hundred and seven hay fever patients, sensitive to birch pollen, were randomized into three parallel groups receiving loratadine 40 mg once daily, clemastine 1 mg twice daily, or placebo during the birch pollen season. Both active treatments showed reduction of symptoms in comparison with placebo, but the results were more pronounced with loratadine treatment, which significantly reduced the overall allergic condition as well as all separate allergic rhino-conjunctivitis symptoms except nasal stuffiness. Compared with placebo the sedation rate was significantly higher with clemastine treatment (P less than 0.05) but not with loratadine. Loratadine was thus concluded to be efficacious in hay fever treatment with a sedation rate not differing from placebo.
[Evaluation of efficacy and safety of loratadine in the treatment of childhood asthma]. [2018]To evaluate the efficacy and safety of loratadine, a new generation of antihistaminics, in the treatment of childhood asthma.
Comparative effects of loratadine and terfenadine in the treatment of chronic idiopathic urticaria. [2013]Loratadine is a new selective peripheral histamine H1-receptor antagonist, that is orally effective, long-acting, and devoid of significant central and autonomic nervous system activity. Its safety and efficacy were evaluated in a 28-day study conducted in patients with chronic idiopathic urticaria. Patients were randomly assigned to one of three treatment groups (loratadine, 10 mg OD; terfenadine, 60 mg BID; or placebo). Evaluation of efficacy included weekly assessments of the individual disease signs and symptoms, the overall disease condition, and therapeutic response to treatment. Throughout the 28-day treatment period progressive improvement was observed in the loratadine and terfenadine treatment groups; however, at each evaluation, loratadine was significantly more effective than placebo (P less than .01) and clinically more effective than terfenadine in reducing disease signs and symptoms. Terfenadine was significantly more effective than placebo at day 7 and endpoint (last valid visit). The overall therapeutic response at the endpoint of treatment was rated as marked or complete relief of symptoms in 64%, 52%, and 25% of the patients in the loratadine, terfenadine, and placebo treatment groups, respectively. Loratadine was well tolerated and comparable to terfenadine and placebo in incidence of adverse experiences. Sedation was reported in one patient each in the terfenadine and placebo treatment groups and an anticholinergic side effect (dry mouth) in one terfenadine-treated patient. No sedative or anticholinergic side effects were observed in patients receiving loratadine. We concluded that loratadine, 10 mg, once daily is a safe and effective treatment for symptomatic relief of chronic idiopathic urticaria.
[Allergic bronchial asthma treated with Loratadine]. [2013]To test the efficacy and tolerability of loratadin, a new anthihistaminic agent in allergic bronchial asthma administered as adjunctive treatment in persistent asthma.
Loratadine. A reappraisal of its pharmacological properties and therapeutic use in allergic disorders. [2018]Loratadine is a long-acting antihistamine agent, exhibiting partial selectivity for peripheral histamine H1-receptors. To date, loratadine has been evaluated in allergic rhinitis, urticaria and, to a limited extent, in asthma. In several large controlled comparative clinical studies, loratadine was superior to placebo, faster acting than astemizole and as effective as azatadine, cetirizine, chlorpheniramine (chlorphenamine), clemastine, hydroxyzine, mequitazine and terfenadine in patients with allergic rhinitis and chronic urticaria. The clinical effectiveness of loratadine in asthma is at present unclear. Loratadine is well tolerated. At dosages of 10 mg daily, commonly reported adverse events were somnolence, fatigue and headache. Sedation occurred less frequently with loratadine than with azatadine, cetirizine, chlorpheniramine, clemastine and mequitazine. Serious ventricular arrhythmias, as reported with some other second generation histamine H1-receptor antagonists, have not been observed with loratadine to date. Thus, loratadine, with its attributes of once daily administration, fast onset of action and essentially nonsedating properties, would appear to be an appropriate first-line agent for the treatment of allergic rhinitis or urticaria.
A multicentre study of loratadine, clemastine and placebo in patients with perennial allergic rhinitis. [2019]This multicentre, double-blind, randomized parallel-group study compared 3 weeks' treatment with either loratadine (Clarityn) 10 mg once daily, or clemastine (Tavegyl) 1 mg twice daily, and placebo in outpatients with active perennial allergic rhinitis. 155 patients were evaluated for efficacy and safety. Grading of four nasal and three non-nasal symptoms, rhinoscopy signs, and therapeutic response was performed on treatment days 6, 13, and 20. Patients recorded daily symptoms and possible adverse experiences in a diary, also indicating when symptoms of active rhinitis were relieved. Loratadine and clemastine were statistically significantly superior to placebo throughout the study (P less than 0.05), based on assessment of patients' nasal and eye symptoms, patients' diary scores, rhinoscopy signs of symptoms, and onset of relief. The loratadine group showed a statistically significantly (P less than 0.05) faster onset of relief of symptoms compared with the group treated with clemastine. Concerning nasal stuffiness, loratadine was significantly (P less than 0.05) superior to clemastine after 1 week's treatment. Reports of adverse reactions showed that significantly (P less than 0.05) more patients complained of sedation in the clemastine than in the loratadine group. Regarding other adverse experiences and laboratory tests, the three treatment groups were statistically comparable (P less than 0.05). The study showed that compared with placebo both loratadine and clemastine were effective in relieving nasal and eye symptoms in patients with perennial allergic rhinitis. Loratadine was safe and well tolerated and was significantly less sedative than clemastine; loratadine may therefore possess an advantage in clinical use in the treatment of perennial allergic rhinitis.
Loratadine and desethoxylcarbonyl-loratadine inhibit the immunological release of mediators from human Fc epsilon RI+ cells. [2019]Loratadine, a novel histamine H1-receptor antagonist, is effective in the treatment of patients with seasonal and perennial rhinitis and some allergic skin disorders. Histamine and other chemical mediators are synthesized and immunologically released by human peripheral blood basophils and tissue mast cells (Fc epsilon RI+ cells).