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Immunomodulatory Agent
Pomalidomide for Multiple Myeloma
Phase 2
Waitlist Available
Led By Anca Prica, M.D.
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days post desensitization
Awards & highlights
Study Summary
This trial is testing a method to allow patients who have an allergic reaction to a cancer drug to continue treatment.
Eligible Conditions
- Multiple Myeloma
- Amyloidosis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 90 days post desensitization
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days post desensitization
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants successfully completing desensitization program
Secondary outcome measures
Distress Assessment and Response Tool (DART) score
Duration of interrupted treatment with immunomodulating agent
Duration of treatment with immunomodulating agent post desensitization
+7 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: PomalidomideExperimental Treatment1 Intervention
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.
Group II: LenalidomideExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pomalidomide
2011
Completed Phase 2
~1020
Lenalidomide
2005
Completed Phase 3
~1480
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,472 Previous Clinical Trials
484,983 Total Patients Enrolled
8 Trials studying Multiple Myeloma
249 Patients Enrolled for Multiple Myeloma
Anca Prica, M.D.Principal InvestigatorPrincess Margaret Cancer Centre
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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