Loratadine for Bone Pain in Multiple Myeloma

Not currently recruiting at 1 trial location

Overseen By Mansi R. Shah, MD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Rutgers, The State University of New Jersey

Must not be taking: Aspirin

Disqualifiers: Non-English speaking, Allergies, others

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Approximately 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether loratadine, an antihistamine commonly used for allergies, can reduce bone pain in patients with multiple myeloma during stem cell collection. Participants will receive either loratadine or a placebo (a harmless pill resembling the actual treatment) to compare results. The trial is ideal for multiple myeloma patients who experience significant bone pain and are preparing for stem cell mobilization. Participants must be able to swallow pills and speak English. As an Early Phase 1 trial, this research aims to understand how loratadine works in people, offering participants a chance to contribute to groundbreaking insights.

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 there any evidence suggesting that loratadine is likely to be safe for humans?

Research has shown that loratadine, a common allergy medicine, might help reduce bone pain from certain treatments. In some studies, patients who took loratadine experienced less pain during treatments that boost white blood cell growth. This is important for patients with multiple myeloma, a type of cancer, who are undergoing stem cell collection. Loratadine is already known to be safe, as it is often used for allergies. While more research is needed to confirm its effect on bone pain, its approval for allergies suggests it is generally safe for most people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for multiple myeloma?

Loratadine is unique because, unlike other treatments for multiple myeloma bone pain that primarily focus on modifying the immune system or directly targeting cancer cells, loratadine is an antihistamine commonly used for allergies. Researchers are excited because it targets histamine receptors, potentially reducing bone pain associated with stem cell mobilization, a side effect not directly addressed by current treatments. This approach offers a novel way to manage pain with a well-known, widely used medication, which might also mean fewer side effects and an easier path to widespread adoption if successful.

What evidence suggests that loratadine might be an effective treatment for bone pain in multiple myeloma?

Research has shown that loratadine, a common allergy medicine, might help reduce bone pain caused by granulocyte-colony stimulating factor (G-CSF) treatment in patients with multiple myeloma. In this trial, some participants will receive loratadine. Specifically, about 42.5% of patients in previous studies reported less bone pain when taking loratadine. Loratadine blocks histamines, substances in the body that can cause pain and swelling. Although information on loratadine's effectiveness for this specific purpose remains limited, early signs suggest it might help manage bone pain during stem cell collection. ^{3 4 5 6 7}

Who Is on the Research Team?

Mansi R. Shah, MD

Principal Investigator

Rutgers Cancer Institute of New Jersey

Are You a Good Fit for This Trial?

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.

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Loratadine

Trial Overview 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.

How Is the Trial Designed?

Group I: Cohort I (loratadine) Experimental Treatment 2 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 Group 2 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

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+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of hay fever with loratadine--a new non-sedating antihistamine. Irander, K., Odkvist, LM., Ohlander, B.[2019]

In a study of 155 patients with perennial allergic rhinitis, both loratadine and clemastine were found to be significantly more effective than placebo in relieving nasal and eye symptoms, with loratadine showing a faster onset of relief.

Loratadine was associated with fewer reports of sedation compared to clemastine, suggesting it may be a safer option for patients needing treatment for allergic rhinitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multicentre study of loratadine, clemastine and placebo in patients with perennial allergic rhinitis. Frølund, L., Etholm, B., Irander, K., et al.[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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cardiac safety evaluation of loratadine in the treatment of allergic rhinitis in elderly patients]. Liu, Y., Cheng, L.[2013]

In a 28-day study involving patients with chronic idiopathic urticaria, loratadine (10 mg once daily) was found to be significantly more effective than placebo in reducing symptoms, with 64% of patients reporting marked or complete relief.

Loratadine was well tolerated, showing no sedative or anticholinergic side effects, making it a safer option compared to terfenadine, which had some reported side effects like sedation and dry mouth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative effects of loratadine and terfenadine in the treatment of chronic idiopathic urticaria. Belaich, S., Bruttmann, G., DeGreef, H., et al.[2013]

Loratadine is an effective long-acting antihistamine that has been shown to be superior to placebo and as effective as other antihistamines for treating allergic rhinitis and chronic urticaria, based on large clinical studies.

It is well tolerated with fewer sedative effects compared to other antihistamines, making it a suitable first-line treatment option, especially since serious side effects like ventricular arrhythmias have not been reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Loratadine. A reappraisal of its pharmacological properties and therapeutic use in allergic disorders. Haria, M., Fitton, A., Peters, DH.[2018]

Loratadine and its metabolite, des-loratadine, effectively inhibit the release of histamine and other inflammatory mediators from human immune cells (Fc epsilon RI+ cells) when challenged, demonstrating their anti-inflammatory properties.

The study showed that both loratadine and des-loratadine can concentration-dependently reduce the release of key mediators like LTC4 and PGD2, suggesting they may be beneficial in treating allergic reactions and conditions like rhinitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Loratadine and desethoxylcarbonyl-loratadine inhibit the immunological release of mediators from human Fc epsilon RI+ cells. Genovese, A., Patella, V., De Crescenzo, G., et al.[2019]

In an eight-week clinical trial with 25 patients, loratadine significantly improved lung function parameters by up to 21% and reduced apneic events by about 52%, indicating its efficacy as an adjunct treatment for persistent allergic bronchial asthma.

71% of patients reported a good therapeutic response to loratadine, and there was a notable decrease in the use of inhalative sympathomimetics, suggesting that loratadine effectively alleviates asthma symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Allergic bronchial asthma treated with Loratadine]. Kroll, VM., Nothofer, B., Werdermann, K.[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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evaluation of efficacy and safety of loratadine in the treatment of childhood asthma]. Maimaiti, G., Abduhaer, A., Xu, PR.[2018]

Citations

1. withpower.com withpower.com/trial/early-phase-1-multiple-myeloma-2021-36fd1

Loratadine for Bone Pain in Multiple Myeloma This trial studies if loratadine, an allergy medicine, can reduce bone pain in multiple myeloma patients who are collecting stem cells.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8033964/

Neurophysiological Mechanisms Related to Pain ... Patients with bone pain of all grades in cycle 1 had 42.5% under treatment with loratadine. Additionally, in a pilot study of 12 patients with various types of ...

3. foxchase.org foxchase.org/news/new-protocol-reduces-side-effects-use-key-drug-multiple-myeloma-patients

New Protocol Reduces Side Effects In Use of Key Drug for ... Fox Chase Cancer Center researchers have identified a pretreatment protocol that reduces side effects for the drug motixafortide, which is sold under the brand ...

4. clinicaltrial.be clinicaltrial.be/en/details/16520?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Loratadine for the Prevention of G-CSF-related Bone Pain... The hypothesis is that prophylaxis with loratadine will help prevent or reduce the severity of bone pain in this setting. Interventions 2 ...

5. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2019-07795

Loratadine for the Reduction of G-CSF Induced Bone Pain ... 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.

6. oncologynurseadvisor.com oncologynurseadvisor.com/features/bone-pain-due-to-white-blood-cell-growth-factors/

Bone Pain Due to White Blood Cell Growth Factors We sometimes use loratadine (Claritin) to treat bone pain in patients receiving white blood cell growth factors.

7. ctv.veeva.com ctv.veeva.com/study/loratadine-for-the-prevention-of-g-csf-related-bone-pain

Loratadine for the Prevention of G-CSF-related Bone Pain The hypothesis is that prophylaxis with loratadine will help prevent or reduce the severity of bone pain in this setting. Adult ≥ 18 years old. ...