Back to resultsA Study to Desensitize Allergic Reactions to Treatments for Blood Disorders
Primary Purpose
Multiple Myeloma, Amyloidosis
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Lenalidomide
Pomalidomide
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma
Eligibility Criteria
Inclusion Criteria:
- Signed Informed Consent
- Adult patients 18 years old or older
- 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.
- Patient diagnosed with multiple myeloma or amyloidosis, with history of HSR to lenalidomide or pomalidomide, who had experienced moderate-severe (Grade ≥2 CTCAE v5.0) cutaneous reactions to IMiDs, with or without being symptomatic (itchy rash). Patients who developed HSR to IMiDs (lenalidomide or pomalidomide) will be assessed according to the CTCAE v 5.0 grading criteria during enrolment, and the severity of the grading (Grade ≥ 2 or otherwise) is recorded for the purpose of future subgroup analysis. OR
- Complained of angioedema or anaphylaxis reactions 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.
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.
- History of Steven-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN) and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).
- 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.
- 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 or previous infection (HepB core Ab +, but HepB sAg negative) 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 IMiDs-related hypersensitivity reaction that is less than Grade 2 (Grade 1) as per CTCAE v5.0.
Sites / Locations
- Princess Margaret Cancer Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Lenalidomide
Pomalidomide
Arm Description
Participants will only receive lenalidomide if they had previously received this drug as a part of their treatment for multiple myeloma or amyloidosis and had experienced an allergic reaction to the drug. Participants will first be given a low dose of lenalidomide with increasing doses over 10-12 steps over 3.5 to 5 hours. Participants will be monitored for side effects or reactions prior to each dose step and any reactions will be managed before giving the increased dose at the next step. The final dose will be determined by the study doctor and is expected to be the dose that participants will restart treatment with lenalidomide at.
Participants will only receive pomalidomide if they had previously received this drug as a part of their treatment for multiple myeloma or amyloidosis and had experienced an allergic reaction to the drug. Participants will first be given a low dose of pomalidomide with increasing doses over 10-12 steps over 3.5 to 5 hours. Participants will be monitored for side effects or reactions prior to each dose step and any reactions will be managed before giving the increased dose at the next step. The final dose will be determined by the study doctor and is expected to be the dose that participants will restart treatment with pomalidomide at.
Outcomes
Primary Outcome Measures
Number of participants successfully completing desensitization program
Secondary Outcome Measures
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
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
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
Full Information
NCT ID
NCT03959358
First Posted
May 8, 2019
Last Updated
July 20, 2023
Sponsor
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT03959358
Brief Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
July 3, 2020 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
October 7, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma, Amyloidosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lenalidomide
Arm Type
Experimental
Arm Description
Participants will only receive lenalidomide if they had previously received this drug as a part of their treatment for multiple myeloma or amyloidosis and had experienced an allergic reaction to the drug.
Participants will first be given a low dose of lenalidomide with increasing doses over 10-12 steps over 3.5 to 5 hours. Participants will be monitored for side effects or reactions prior to each dose step and any reactions will be managed before giving the increased dose at the next step.
The final dose will be determined by the study doctor and is expected to be the dose that participants will restart treatment with lenalidomide at.
Arm Title
Pomalidomide
Arm Type
Experimental
Arm Description
Participants will only receive pomalidomide if they had previously received this drug as a part of their treatment for multiple myeloma or amyloidosis and had experienced an allergic reaction to the drug.
Participants will first be given a low dose of pomalidomide with increasing doses over 10-12 steps over 3.5 to 5 hours. Participants will be monitored for side effects or reactions prior to each dose step and any reactions will be managed before giving the increased dose at the next step.
The final dose will be determined by the study doctor and is expected to be the dose that participants will restart treatment with pomalidomide at.
Intervention Type
Drug
Intervention Name(s)
Lenalidomide
Other Intervention Name(s)
REVLIMID
Intervention Description
Lenalidomide is an antineoplastic and immunomodulatory agent that will be given as a liquid in syringes to be taken orally (by mouth).
Intervention Type
Drug
Intervention Name(s)
Pomalidomide
Other Intervention Name(s)
POMALYST
Intervention Description
Pomalidomide is an antineoplastic and immunomodulatory agent that will be given as a liquid in syringes to be taken orally (by mouth).
Primary Outcome Measure Information:
Title
Number of participants successfully completing desensitization program
Time Frame
12 days
Secondary Outcome Measure Information:
Title
Distress Assessment and Response Tool (DART) score
Description
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
Title
Edmonton Symptom Assessment System (ESAS) score
Description
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
Title
Frequency of interrupted treatment with immunomodulating agent
Time Frame
90 days post desensitization program
Title
Duration of interrupted treatment with immunomodulating agent
Time Frame
90 days post desensitization program
Title
Mortality rate associated with disease progression or treatment-related toxicity
Time Frame
90 days post desensitization program
Title
Frequency of rash recurrence
Time Frame
90 days post desensitization
Title
Duration of treatment with immunomodulating agent post desensitization
Time Frame
90 days post desensitization
Title
Incidence of adverse events during desensitization procedures and hospital stay
Time Frame
12 days
Title
Total duration of treatment with immunomodulating agent
Time Frame
90 days post desensitization
Title
Duration of treatment with supportive care agents
Time Frame
90 days post desensitization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signed Informed Consent
Adult patients 18 years old or older
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.
Patient diagnosed with multiple myeloma or amyloidosis, with history of HSR to lenalidomide or pomalidomide, who had experienced moderate-severe (Grade ≥2 CTCAE v5.0) cutaneous reactions to IMiDs, with or without being symptomatic (itchy rash). Patients who developed HSR to IMiDs (lenalidomide or pomalidomide) will be assessed according to the CTCAE v 5.0 grading criteria during enrolment, and the severity of the grading (Grade ≥ 2 or otherwise) is recorded for the purpose of future subgroup analysis. OR
Complained of angioedema or anaphylaxis reactions 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.
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.
History of Steven-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN) and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).
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.
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 or previous infection (HepB core Ab +, but HepB sAg negative) 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 IMiDs-related hypersensitivity reaction that is less than Grade 2 (Grade 1) as per CTCAE v5.0.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anca Prica, M.D.
Organizational Affiliation
Princess Margaret Cancer Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
A Study to Desensitize Allergic Reactions to Treatments for Blood Disorders
We'll reach out to this number within 24 hrs