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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 5 days after completion of stem cell mobilization
Awards & highlights

Study Summary

This trial will study how well loratadine reduces G-CSF-induced bone pain in patients with multiple myeloma undergoing stem cell mobilization.

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.Check my eligibility
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.See study design
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
Select...
I can swallow and keep down pills.
Select...
I have been diagnosed with multiple myeloma.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
76%
Injection site discomfort
18%
Injection site pruritus
18%
Headache
12%
Injection site erythema
12%
Oropharyngeal pain
6%
Injection site anaesthesia
6%
Injection site nodule
6%
Viral infection
6%
Skin tightness
6%
Injection site rash
100%
80%
60%
40%
20%
0%
Study treatment Arm
Paradigm 1 / Deoxycholic Acid Injection
Paradigm 1 / Placebo
Paradigm 3 / Deoxycholic Acid Injection
Paradigm 2 / Deoxycholic Acid Injection
Paradigm 2 / Placebo
Paradigm 3 / Placebo
Paradigm 4 / Deoxycholic Acid Injection
Paradigm 4 / 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

Find a Location

Who is running the clinical trial?

Rutgers, The State University of New JerseyLead Sponsor
429 Previous Clinical Trials
64,162 Total Patients Enrolled
3 Trials studying Multiple Myeloma
32 Patients Enrolled for Multiple Myeloma
National Cancer Institute (NCI)NIH
13,664 Previous Clinical Trials
40,926,063 Total Patients Enrolled
579 Trials studying Multiple Myeloma
189,061 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research experiment still open to volunteer participants?

"Affirmative. The information hosted on clinicaltrials.gov highlights that recruitment for this trial, which was first advertised on April 18th 2022, is ongoing. A total of 70 patients are needed from two distinct medical centres."

Answered by AI

What is the sample size of subjects receiving treatment in this investigation?

"Affirmative. According to the clinicaltrials.gov database, this clinical trial is actively recruiting and requires 70 individuals from two different sites. The posting was initially published on April 18th 2022 with its most recent edit being October 17th 2022."

Answered by AI

Has there been any prior research conducted on Loratadine?

"Currently, Loratadine is being tested in two active trials with none of them at Phase 3. 8 different medical centres are involved and the majority of these studies are conducted in Barcelona."

Answered by AI

What illnesses is Loratadine often prescribed to treat?

"Loratadine is the top choice for treating eye-related conditions such as catarrh, epiphora, and rhinorrhoea. It is also a popular medication for relieving general symptoms of hay fever or other allergies."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Loratadine for the Reduction of G-CSF Induced Bone Pain in Patients With Multiple Myeloma Undergoing Stem Cell Mobilization
Mansi Shah, MD 2022. "Loratadine for the Reduction of G-CSF Induced Bone Pain in Patients With Multiple Myeloma Undergoing Stem Cell Mobilization". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04211259.
~23 spots leftby Apr 2025
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