Loratadine Arm for Stem Cell Transplant Complications

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Cross Cancer Institute, Edmonton, Canada
Stem Cell Transplant Complications
Loratadine - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The research question for the current study is: Is loratadine more effective than placebo in preventing G-CSF-related bone pain during autologous hematopoetic stem cell transplant in patients with lymphoma or multiple myeloma? The hypothesis is that prophylaxis with loratadine will help prevent or reduce the severity of bone pain in this setting.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Stem Cell Transplant Complications

Study Objectives

3 Primary · 6 Secondary · Reporting Duration: Patients will be followed for 1 year after completion of the study treatment.

Day 12
Bone Pain Interference (Brief Pain Inventory)
Bone Pain Severity (Brief Pain Inventory)
Year 1
Progression free survival
Day 12
Bone pain severity (QLQ-BM22)
Day 8
Qualitative breakthrough of pain control use
Day 8
Rate of pain control use
Single measurement after all patients have completed end of treatment.
Rate of plerixafor use during in each study arm
Day 8
Stem cell mobilization efficacy
Day 8
Mean time to stem cell re-engraftment

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Stem Cell Transplant Complications

Side Effects for

Paradigm 1 / Deoxycholic Acid Injection
100%Injection site pain
100%Injection site haemorrhage
100%Injection site induration
100%Injection site oedema
76%Injection site discomfort
18%Injection site pruritus
18%Headache
12%Oropharyngeal pain
12%Injection site erythema
6%Injection site nodule
6%Skin tightness
6%Injection site anaesthesia
6%Injection site rash
6%Viral infection
0%Dyspepsia
0%Fatigue
0%Respiratory tract infection
0%Back pain
0%Folliculitis
0%Application site alopecia
0%Pain in jaw
0%Ear pain
0%Disturbance in attention
0%Pharyngitis
0%Bronchitis
0%Muscle strain
0%Injection site haematoma
0%Injection site dysaesthesia
0%Ecchymosis
0%Tooth abscess
0%Aspartate aminotransferase increased
0%Muscle tightness
0%Neck pain
0%Sinusitis
0%Pneumonia
0%Nasal congestion
This histogram enumerates side effects from a completed 2014 Phase 3 trial (NCT02007434) in the Paradigm 1 / Deoxycholic Acid Injection ARM group. Side effects include: Injection site pain with 100%, Injection site haemorrhage with 100%, Injection site induration with 100%, Injection site oedema with 100%, Injection site discomfort with 76%.

Trial Design

2 Treatment Groups

Loratadine Arm
1 of 2
Placebo Arm
1 of 2
Experimental Treatment
Non-Treatment Group

78 Total Participants · 2 Treatment Groups

Primary Treatment: Loratadine Arm · Has Placebo Group · Phase 2

Loratadine Arm
Drug
Experimental Group · 1 Intervention: Loratadine · Intervention Types: Drug
Placebo Arm
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Loratadine
2011
Completed Phase 4
~5050

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: patients will be followed for 1 year after completion of the study treatment.
Closest Location: Cross Cancer Institute · Edmonton, Canada
Photo of Edmonton  1Photo of Edmonton  2Photo of Edmonton  3
2011First Recorded Clinical Trial
1 TrialsResearching Stem Cell Transplant Complications
401 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a histologically or cytologically documented lymphoma or multiple myeloma.
You have a performance status of 0-2.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.