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Multiple MyelomaPhase 2NCT03959358

A Study to Desensitize Allergic Reactions to Treatments for Blood Disorders

A Phase 2 study testing Lenalidomide and Pomalidomide in people with Multiple Myeloma and Amyloidosis, run by University Health Network, Toronto at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma, Amyloidosis
What is being tested?
Lenalidomide and Pomalidomide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteCanada
Study dates
3 Jul 2020to 7 Oct 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

Official title: Desensitization of Immunomodulating Agent-Related Hypersensitivity Reactions as a Means to Provide Therapeutic Options in the Management of Plasma Cell Disorders (DeHyperPCD)

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.

Read the 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.

Medical subject headings
Multiple Myeloma, Amyloidosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LenalidomideDrug

    Also called REVLIMID

    Lenalidomide is an antineoplastic and immunomodulatory agent that will be given as a liquid in syringes to be taken orally (by mouth).

  • PomalidomideDrug

    Also called POMALYST

    Pomalidomide is an antineoplastic and immunomodulatory agent that will be given as a liquid in syringes to be taken orally (by mouth).

Study groups in NCT03959358
Study groupRoleWhat they receive
LenalidomideExperimentalParticipants 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.
Receives: Drug: Lenalidomide
PomalidomideExperimentalParticipants 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.
Receives: Drug: Pomalidomide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants successfully completing desensitization program

    Measured: 12 days

Secondary outcomes (10)

  1. 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

    Measured: 90 days post desensitization program

  2. 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

    Measured: 90 days post desensitization program

  3. Frequency of interrupted treatment with immunomodulating agent

    Measured: 90 days post desensitization program

  4. Duration of interrupted treatment with immunomodulating agent

    Measured: 90 days post desensitization program

  5. Mortality rate associated with disease progression or treatment-related toxicity

    Measured: 90 days post desensitization program

  6. Frequency of rash recurrence

    Measured: 90 days post desensitization

  7. Duration of treatment with immunomodulating agent post desensitization

    Measured: 90 days post desensitization

  8. Incidence of adverse events during desensitization procedures and hospital stay

    Measured: 12 days

  9. Total duration of treatment with immunomodulating agent

    Measured: 90 days post desensitization

  10. Duration of treatment with supportive care agents

    Measured: 90 days post desensitization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2019
  2. Study start3 Jul 2020
  3. Primary completion30 Jun 2022
  4. Study completion7 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03959358
Sponsor's protocol ID
DeHyperPCD
Other IDs
RV-CL-MM-PI-13170
Status last verified
Jul 2023
First submitted
8 May 2019
Last updated
24 Jul 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lenalidomide and Pomalidomide in people with Multiple Myeloma and Amyloidosis, run by University Health Network, Toronto at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants successfully completing desensitization program (time frame: 12 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03959358.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2023.

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