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A Study to Desensitize Allergic Reactions to Treatments for Blood Disorders

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ClinicalTrials.gov Identifier: NCT03959358
Recruitment Status : Not yet recruiting
First Posted : May 22, 2019
Last Update Posted : May 24, 2019
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Tracking Information
First Submitted Date  ICMJE May 8, 2019
First Posted Date  ICMJE May 22, 2019
Last Update Posted Date May 24, 2019
Estimated Study Start Date  ICMJE June 2019
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2019)
Number of participants successfully completing desensitization program [ Time Frame: 12 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03959358 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2019)
  • Distress Assessment and Response Tool (DART) score [ Time Frame: 90 days post desensitization program ]
    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 [ Time Frame: 90 days post desensitization program ]
    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 [ 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2019)
  • Distress Assessment and Response Tool (DART) score [ Time Frame: 90 days post desensitization program ]
  • Edmonton Symptom Assessment System (ESAS) score [ 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 ]
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Desensitize Allergic Reactions to Treatments for Blood Disorders
Official Title  ICMJE Desensitization of Immunomodulating Agent-Related Hypersensitivity Reactions as a Means to Provide Therapeutic Options in the Management of Plasma Cell Disorders
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Multiple Myeloma
  • Amyloidosis
Intervention  ICMJE
  • Drug: Lenalidomide
    Lenalidomide is an antineoplastic and immunomodulatory agent that will be given as a liquid in syringes to be taken orally (by mouth).
    Other Name: REVLIMID
  • Drug: Pomalidomide
    Pomalidomide is an antineoplastic and immunomodulatory agent that will be given as a liquid in syringes to be taken orally (by mouth).
    Other Name: POMALYST
Study Arms  ICMJE
  • Experimental: Lenalidomide

    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.

    Intervention: Drug: Lenalidomide
  • Experimental: Pomalidomide

    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: Drug: Pomalidomide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 20, 2019)
26
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Anca Prica, M.D. 416-946-2249 anca.prica@uhn.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03959358
Other Study ID Numbers  ICMJE 19-5404
RV-CL-MM-PI-13170 / DeHyperPCD ( Other Identifier: Princess Margaret Cancer Centre )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Health Network, Toronto
Study Sponsor  ICMJE University Health Network, Toronto
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Anca Prica, M.D. Princess Margaret Cancer Centre
PRS Account University Health Network, Toronto
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP