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Antihistamine

Loratadine for Stem Cell Transplant Bone Pain

Phase 2

Waitlist Available

Research Sponsored by AHS Cancer Control Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

A histologically or cytologically documented lymphoma or multiple myeloma

Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up patients will be followed for 1 year after completion of the study treatment.

Awards & highlights

All Individual Drugs Already Approved

Summary

This trial is testing whether the drug loratadine is better than a placebo at preventing bone pain in cancer patients undergoing stem cell transplants.

Who is the study for?

This trial is for adults over 18 with lymphoma or multiple myeloma who are about to have a stem cell transplant. They should be relatively healthy, able to follow the study plan, and not have used antihistamines or painkillers recently. People with severe diseases like heart failure or diabetes that aren't well-managed can't join.

What is being tested?

The trial is testing if Loratadine, an antihistamine, can prevent or lessen bone pain caused by G-CSF injections in patients undergoing stem cell transplants compared to a placebo (a substance with no active drug).

What are the potential side effects?

Loratadine may cause drowsiness, headache, increased appetite, difficulty sleeping, dry mouth and fatigue. However, it's generally considered safe with minimal side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is either lymphoma or multiple myeloma, confirmed by lab tests.

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I am able to care for myself and perform daily activities.

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I do not have any severe illnesses like heart failure, uncontrolled diabetes, liver or kidney failure.

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My next treatment is a stem cell transplant using my own cells.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ patients will be followed for 1 year after completion of the study treatment.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~patients will be followed for 1 year after completion of the study treatment.

This trial's timeline: 3 weeks for screening, Varies for treatment, and patients will be followed for 1 year after completion of the study treatment. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Bone Pain Interference (Brief Pain Inventory)

Bone Pain Severity (Brief Pain Inventory)

Bone pain severity (QLQ-BM22)

Secondary study objectives

Mean time to stem cell re-engraftment

Progression free survival

Qualitative breakthrough of pain control use

+3 more

Side effects data

From 2014 Phase 3 trial • 84 Patients • NCT02007434

100%

Injection site pain

100%

Injection site induration

100%

Injection site oedema

94%

Injection site haemorrhage

44%

Injection site discomfort

17%

Headache

Aspartate aminotransferase increased

Tooth abscess

Dyspepsia

Ear pain

Oropharyngeal pain

Pneumonia

Pharyngitis

Injection site erythema

Back pain

Neck pain

100%

80%

60%

40%

20%

Study treatment Arm

Paradigm 4 / Deoxycholic Acid Injection

Paradigm 3 / Placebo

Paradigm 3 / Deoxycholic Acid Injection

Paradigm 2 / Placebo

Paradigm 1 / Deoxycholic Acid Injection

Paradigm 2 / Deoxycholic Acid Injection

Paradigm 4 / Placebo

Paradigm 1 / Placebo

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Loratadine ArmExperimental Treatment1 Intervention

Loratadine 10mg, administered initially 3 hours before the first dose of G-CSF in the autologous stem cell mobilization protocol, and then daily for a minimum of 8 days.

Group II: Placebo ArmPlacebo Group1 Intervention

Placebo capsule, administered initially 3 hours before the first dose of G-CSF in the autologous stem cell mobilization protocol, and then daily for a minimum of 8 days.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Loratadine

FDA approved

0 / 5Eligibility criteria met