A Study to Desensitize Allergic Reactions to Treatments for Blood Disorders

Official Title

Desensitization of Immunomodulating Agent-Related Hypersensitivity Reactions as a Means to Provide Therapeutic Options in the Management of Plasma Cell Disorders (DeHyperPCD)

Summary:

Patients with multiple myeloma (a type of blood cancer affecting the white blood cells) or amyloidosis (abnormal buildup of a protein called amyloid in the body) are often given treatment with the drugs lenalidomide or pomalidomide. Some patients may experience an allergic reaction to these drugs which would mean stopping the treatment. The purpose of this research study is to see how safe and useful desensitization is in allowing patients to receive further treatment with lenalidomide or pomalidomide.

Trial Description

Primary Outcome:

• Number of participants successfully completing desensitization program

Secondary Outcome:

• Distress Assessment and Response Tool (DART) score
• Edmonton Symptom Assessment System (ESAS) score
• Frequency of interrupted treatment with immunomodulating agent
• Duration of interrupted treatment with immunomodulating agent
• Mortality rate associated with disease progression or treatment-related toxicity
• Frequency of rash recurrence
• Duration of treatment with immunomodulating agent post desensitization
• Incidence of adverse events during desensitization procedures and hospital stay
• Total duration of treatment with immunomodulating agent
• Duration of treatment with supportive care agents

Some doctors believe that the body may be taught to react less or stop reacting to, the things that would otherwise trigger an allergic reaction. This is called desensitization. Desensitization is usually done with repeat exposure to the thing that causes the allergic reaction. For example, people who have allergies may receive small, controlled doses of the allergen over a period of time until the allergic reactions are tolerable or are stopped completely. The researchers want to see if giving low doses of lenalidomide or pomalidomide to people who experienced an allergic reaction to these medications can become desensitized so that they are able to continue treatment for their disease with these drugs.

View this trial on ClinicalTrials.gov