A Study to Desensitize Allergic Reactions to Treatments for Blood Disorders

• Status: Recruiting
• Trial end date: 2023-04-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Health Network, Toronto
• Treatments: Lenalidomide; Pomalidomide; Thalidomide

Criteria

Inclusion Criteria:

• Signed Informed Consent

• Adult patients 18 years old or older

• History of hypersensitivity reactions (HSR) to lenalidomide or pomalidomide within 30 days of signing consent.

• All study participants must be registered into the mandatory Lenalidomide or Pomalidomide Pregnancy Prevention Plan, and be willing and able to comply with the requirements.

• Females of reproductive potential must adhere to the pregnancy testing and contraceptive techniques as required by the Pregnancy Prevention Plan.

• Diagnosed with multiple myeloma or amyloidosis, who had experienced moderately-severe cutaneous reactions, with or without being symptomatic (itchy rash) to immunomodulating agents (IMiDs) OR complained of angioedema or anaphylaxis reactions (in additional to body rash), attributable to lenalidomide or pomalidomide.

• Patients must be afebrile at least 48 hours prior to proposed desensitization day.

• For patients with existing body rash, a complete resolution of rash is needed prior to Rapid Desensitization Program procedures at least 7 days prior to desensitization.

• Patients may continue to administer their current medication prior to the start of Rapid Desensitization Program (RDP). Best possible medication history will be taken prior to RDP, with the exception of withholding beta- blockers on the day of desensitization. Patient's allergy history will be documented.

• Patients with other allergy history may also be included.

Exclusion Criteria:

• Female who is pregnant or suspected of being pregnant or breast feeding or likely to breast feed during the study duration

• Inability to take oral medications.

• Disease progression on immunomodulating agents (IMiDs).

• History of Steven-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN) and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).

• Developed resistance to IMiDs. Resistance is defined as IMiDs that are no longer active against myeloma, resulting in clinical deterioration.

• Patients who are taking IMiDs-based therapy for an indication other than multiple myeloma (MM) and/or systemic amyloidosis (AL).

• The development of erythema nodosum, if characterized by a desquamating rash while taking thalidomide, IMiDs or similar drugs.

• Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are seropositive because of hepatitis B virus vaccine are eligible.

• Patients who, for whatever reason, are unable to tolerate IMiDs (other than hypersensitivity reactions).

• Patients who have completed 3 RDPs and continued to have breakthrough hypersensitivity reactions (HSR) post Rapid Desensitization Program (RDP).

• Patients who had experienced a IMiDs-related hypersensitivity reaction that is less than Grade 3 (Grade 1 and 2) as per Common Terminology Criteria for Adverse Events (CTCAE) v5.0.