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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Lenalidomide is an antineoplastic and immunomodulatory agent that will be given as a liquid in syringes to be taken orally (by mouth).
Pomalidomide is an antineoplastic and immunomodulatory agent that will be given as a liquid in syringes to be taken orally (by mouth).
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Number of participants successfully completing desensitization program
Time frame: 12 days
Distress Assessment and Response Tool (DART) score
Rating of physical symptoms, practical concerns, and emotional concerns on a scale from 1-10. 0 = no symptoms/concerns, 10=worse possible experience of the symptom/concern
Time frame: 90 days post desensitization program
Edmonton Symptom Assessment System (ESAS) score
A rating of nine common symptoms on a scale from 0-10. 0 = no symptoms, 10=worse possible experience of the symptom
Time frame: 90 days post desensitization program
Frequency of interrupted treatment with immunomodulating agent
Time frame: 90 days post desensitization program
Duration of interrupted treatment with immunomodulating agent
Time frame: 90 days post desensitization program
Mortality rate associated with disease progression or treatment-related toxicity
Time frame: 90 days post desensitization program
Frequency of rash recurrence
Time frame: 90 days post desensitization
Duration of treatment with immunomodulating agent post desensitization
Time frame: 90 days post desensitization
Incidence of adverse events during desensitization procedures and hospital stay
Time frame: 12 days
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Total duration of treatment with immunomodulating agent
Time frame: 90 days post desensitization
Duration of treatment with supportive care agents
Time frame: 90 days post desensitization