What side effects are associated with this type of intervention?

Common treatments for Multiple Myeloma, such as lenalidomide, pomalidomide, bortezomib, and dexamethasone, have several side effects. Lenalidomide and pomalidomide can cause cytopenias, fatigue, edema, gastrointestinal issues, and rash. Bortezomib is associated with peripheral neuropathy, gastrointestinal distress, and cytopenias. Dexamethasone can lead to hyperglycemia, increased risk of infections, and mood changes. These side effects vary in severity and frequency, and patients should discuss them with their healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for Multiple Myeloma, including lenalidomide plus low-dose dexamethasone (Rd), which is effective for initial treatment, especially in frail patients. Other approved regimens include elotuzumab, lenalidomide, and dexamethasone (ERd) for relapsed or refractory cases, and daratumumab in combination with other agents. While loratadine, an antihistamine, is being studied for its potential to reduce G-CSF induced bone pain in Multiple Myeloma patients undergoing stem cell mobilization, it is not yet a standard treatment for Multiple Myeloma itself.

What other types of research exist?

Promising novel alternatives to Loratadine for reducing bone pain in Multiple Myeloma patients include bisphosphonates (e.g., zoledronic acid), denosumab (a RANKL inhibitor), and newer analgesics such as monoclonal antibodies targeting specific pain pathways. Additionally, advancements in personalized medicine and targeted therapies may offer new options for pain management in these patients.

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Antihistamine

Loratadine for Bone Pain in Multiple Myeloma

Q: What is the mechanism of action of this treatment?

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.

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

Select...

I can swallow and keep down pills.

Select...

I have been diagnosed with multiple myeloma.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have taken more than 81 mg of aspirin daily in the week before the study starts.

Select...

I am getting a stem cell transplant from a partially matched donor.

Select...

I do not speak English.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to 5 days after completion of stem cell mobilization

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

Nasal congestion

Injection site haematoma

Injection site pruritus

Bronchitis

Folliculitis

Ecchymosis

Application site alopecia

Fatigue

Respiratory tract infection

Sinusitis

Headache

Injection site dysaesthesia

100%

80%

60%

40%

20%

Study treatment Arm

Paradigm 3 / Deoxycholic Acid Injection

Paradigm 3 / Placebo

Paradigm 2 / Placebo

Paradigm 1 / Deoxycholic Acid Injection

Paradigm 2 / Deoxycholic Acid Injection

Paradigm 4 / 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

0 / 5Eligibility criteria met

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.