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Antihistamine

Loratadine for Bone Pain in Multiple Myeloma

Phase < 1
Recruiting
Led By Dennis L Cooper
Research Sponsored by Rutgers, The State University of New Jersey
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Able to swallow and retain oral medication
Patients with confirmed diagnosis of multiple myeloma
Must not have
On therapeutic dose of aspirin (doses greater than 81 mg) within 7 days prior to the start of the study
Patients undergoing haploidentical allogeneic hematopoietic stem cell transplant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 5 days after completion of stem cell mobilization

Summary

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.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Loratadine may cause drowsiness, headache, increased heart rate, stomach pain, dry mouth/nose/throat; however side effects vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can swallow and keep down pills.
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I have been diagnosed with multiple myeloma.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have taken more than 81 mg of aspirin daily in the week before the study starts.
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I am getting a stem cell transplant from a partially matched donor.
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I do not speak English.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 5 days after completion of stem cell mobilization
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 5 days after completion of stem cell mobilization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in mean pain level for each group following therapy

Side effects data

From 2014 Phase 3 trial • 84 Patients • NCT02007434
100%
Injection site haemorrhage
100%
Injection site induration
100%
Injection site oedema
100%
Injection site pain
69%
Injection site discomfort
6%
Nasal congestion
6%
Injection site haematoma
6%
Injection site pruritus
6%
Bronchitis
6%
Folliculitis
6%
Ecchymosis
6%
Application site alopecia
6%
Fatigue
6%
Respiratory tract infection
6%
Sinusitis
6%
Headache
6%
Injection site dysaesthesia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Paradigm 3 / Deoxycholic Acid Injection
Paradigm 3 / Placebo
Paradigm 2 / Placebo
Paradigm 1 / Deoxycholic Acid Injection
Paradigm 4 / Deoxycholic Acid Injection
Paradigm 2 / Deoxycholic Acid Injection
Paradigm 4 / Placebo
Paradigm 1 / Placebo

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Loratadine
2011
Completed Phase 4
~5330

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Multiple Myeloma (MM) include lenalidomide, bortezomib, and dexamethasone. Lenalidomide works by enhancing the immune response and inhibiting blood vessel growth in tumors. Bortezomib disrupts the degradation of proteins within cancer cells, leading to their death. Dexamethasone reduces inflammation and suppresses the immune system. These treatments are essential for MM patients as they target various pathways to control the disease. Additionally, loratadine, an antihistamine, is being studied for its potential to reduce bone pain by blocking histamine receptors, which could significantly improve the quality of life for MM patients.
Emerging drugs in multiple myeloma.

Find a Location

Who is running the clinical trial?

Rutgers, The State University of New JerseyLead Sponsor
448 Previous Clinical Trials
66,609 Total Patients Enrolled
3 Trials studying Multiple Myeloma
32 Patients Enrolled for Multiple Myeloma
National Cancer Institute (NCI)NIH
13,907 Previous Clinical Trials
41,011,990 Total Patients Enrolled
594 Trials studying Multiple Myeloma
190,980 Patients Enrolled for Multiple Myeloma
Dennis L CooperPrincipal InvestigatorRutgers Cancer Institute of New Jersey

Media Library

Loratadine (Antihistamine) Clinical Trial Eligibility Overview. Trial Name: NCT04211259 — Phase < 1
Multiple Myeloma Research Study Groups: Cohort II (placebo), Cohort I (loratadine)
Multiple Myeloma Clinical Trial 2023: Loratadine Highlights & Side Effects. Trial Name: NCT04211259 — Phase < 1
Loratadine (Antihistamine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04211259 — Phase < 1
~20 spots leftby Nov 2025