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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

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.


Condition or disease Intervention/treatment Phase
Multiple Myeloma Amyloidosis Drug: Lenalidomide Drug: Pomalidomide Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Desensitization of Immunomodulating Agent-Related Hypersensitivity Reactions as a Means to Provide Therapeutic Options in the Management of Plasma Cell Disorders
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : December 2022


Arm Intervention/treatment
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.

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

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.

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




Primary Outcome Measures :
  1. Number of participants successfully completing desensitization program [ Time Frame: 12 days ]

Secondary Outcome Measures :
  1. 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

  2. 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

  3. Frequency of interrupted treatment with immunomodulating agent [ Time Frame: 90 days post desensitization program ]
  4. Duration of interrupted treatment with immunomodulating agent [ Time Frame: 90 days post desensitization program ]
  5. Mortality rate associated with disease progression or treatment-related toxicity [ Time Frame: 90 days post desensitization program ]
  6. Frequency of rash recurrence [ Time Frame: 90 days post desensitization ]
  7. Duration of treatment with immunomodulating agent post desensitization [ Time Frame: 90 days post desensitization ]
  8. Incidence of adverse events during desensitization procedures and hospital stay [ Time Frame: 12 days ]
  9. Total duration of treatment with immunomodulating agent [ Time Frame: 90 days post desensitization ]
  10. Duration of treatment with supportive care agents [ Time Frame: 90 days post desensitization ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03959358


Contacts
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Contact: Anca Prica, M.D. 416-946-2249 anca.prica@uhn.ca

Locations
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Canada, Ontario
Princess Margaret Cancer Centre Not yet recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Anca Prica, M.D.    416-946-2249    anca.prica@uhn.ca   
Principal Investigator: Anca Prica, M.D.         
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Anca Prica, M.D. Princess Margaret Cancer Centre

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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03959358     History of Changes
Other Study ID Numbers: 19-5404
RV-CL-MM-PI-13170 / DeHyperPCD ( Other Identifier: Princess Margaret Cancer Centre )
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Multiple Myeloma
Amyloidosis
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Proteostasis Deficiencies
Metabolic Diseases
Lenalidomide
Pomalidomide
Thalidomide
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents