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Lenalidomide Discontinuation Study

Primary Purpose

Multiple Myeloma, Cancer, Hematologic Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Discontinuation of maintenance treatment
Sponsored by
University College Cork
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Multiple Myeloma focused on measuring Multiple Myeloma, Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 18 years of age or over Patient with diagnosis of multiple myeloma as per IMWC in first line of treatment. Received at least 2 years of maintenance therapy, defined as any anti-myeloma therapy to prevent disease recurrence and prolong time in remission (i.e., lenalidomide) Patients who have discontinued maintenance therapy earlier than 2 years due to side effects but also achieved sustained MRD negative CR might be also included Patients must be able to understand and be willing to sign a voluntary informed consent form and agree to compliance with the protocol schedule, with the knowledge that they may withdraw consent at any time without impact on future medical care. Exclusion Criteria: Patients who have received more than one line of therapy or patients who have not completer two years of maintenance therapy, unless maintenance was discontinued voluntarily and the patient has achieved sustainable MRD negative remission. Patients with plasma cell disorders other than MM: lymphoplasmacytic lymphoma/Waldenstrom macroglobulinemia, AL amyloidosis, POEMS syndrome (Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal protein, and Skin changes), etc… Prior organ transplant or condition requiring immunosuppressive therapy. Prior allogenic haematopoietic cell transplant Treatment with any investigational therapy that does not include maintenance as a part of the treatment strategy. Unable to sign an informed consent form.

Sites / Locations

  • Cork University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

No Intervention

Other

Arm Label

Group 1

Group 2 Subgroup A

Group 2 Subgroup B

Arm Description

Continuing Maintenance Therapy- Patients with biochemically detectable disease who have failed to achieve Complete remission (CR) or Very good Partial Remission (VGPR) by IMWG criteria and/or MRD-positive and/or high risk features. They will continue maintenance therapy until disease progression with monitoring every 3 months as per standard of care (SOC), or more often if required. In case of disease progression these patients will be switched to a different treatment and withdraw from the study. QOL will be assessed.

Continuing Maintenance Therapy- Patients in biochemical remission, who meet IMWG criteria for very good partial response (VGPR) or complete response (CR and and sustained MRD (defined as MRD-negative at two time points that are at least 1 year apart) without high risk features. High-risk cytogenetics abnormalities defined as per IMWG criteria (del(17p) and/or t(4;14) and/or t(14;16)) , or any other features suggestive of high risk disease: extramedullary disease, poor response to first line therapy, plasma cell leukaemia, organomegaly secondary to infiltration by multiple myeloma. Maintenance will continue until disease progression, monitored every 3 months as per SOC or more often if required. In case of disease progression these patients will be switched to a different treatment and withdraw from the study. QOL will be assessed.

Patients who prefer to discontinue maintenance therapy. Patients who have discontinued maintenance therapy earlier than 2 years due to side effects but also achieved sustained MRD negative CR might be also included in this subgroup. This subgroup will be monitored and per SOC with blood tests, and BM MRD by NGF. In case of detectable disease in any of the samples (blood or BM) they will be offered to restart on maintenance therapy. Changing to a different type of treatment could be also offered to these patients, after discussion with treating physician. In case of being switched to a different treatment patient will withdraw from the study. QOL will be assessed

Outcomes

Primary Outcome Measures

Number of participants that remain in sustained MRD negative remission by NGF in the bone marrow at 12 months after discontinuation of maintenance therapy.

Secondary Outcome Measures

Number of participants that remain in sustained MRD negative remission by NGF in the bone marrow at 24 months after discontinuation of maintenance therapy.
Progression-free survival in multiple myeloma patients at 1 year in both groups of patients (on maintenance therapy and those who have discontinued)
Progression-free survival in multiple myeloma patients at 2 years in both groups of patients (on maintenance therapy and those who have discontinued)
Compare health-related quality of life between MM patients discontinuing versus continuing maintenance therapy using a QOL questionnaire

Full Information

First Posted
May 10, 2023
Last Updated
May 10, 2023
Sponsor
University College Cork
Collaborators
Cancer Research@UCC
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1. Study Identification

Unique Protocol Identification Number
NCT05866757
Brief Title
Lenalidomide Discontinuation Study
Official Title
Discontinuation of Lenalidomide Maintenance for the Patients Diagnosed With Multiple Myeloma in Sustainable Minimal Residual Disease (MRD) Negative Remission Without High Risk Features
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 2023 (Anticipated)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University College Cork
Collaborators
Cancer Research@UCC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
An interventional, non-randomised study to assess the risk of progression after discontinuation of maintenance therapy in sustained MRD negative complete remission by flow cytometry MM patients without high-risk features who have completed at least two years of maintenance therapy with lenalidomide or who have discontinued lenalidomide maintenance due to side effects. The primary endpoint is to assess the rates of sustained MRD negativity by NGF in the bone marrow at 12 months after discontinuation of maintenance therapy.
Detailed Description
Up to 70 patients over 18 years of age who have a diagnosis of Multiple Myeloma and have completed at least 2 years of lenalidomide maintenance therapy. Participants would be divided in two groups: Group 1. Patients with detectable disease, failed to achieve Complete Remission (CR) or Very Good Partial Remission (VGPR) continuing on maintenance therapy. Group 2. Patients who meet International Myeloma working Group (IMWG) criteria for very good partial response (VGPR) or complete response (CR). Patients who have achieved sustained MRD negative remission by next generation flow cytometry (NGF),defined by IMWG as MRD-negative at two time points that are at least 1 year apart, To the participants in this group will be offered to discontinue maintenance therapy, and it will be further divided in the following subgroups: Subgroup A) Patients who are willing to continue maintenance therapy. Subgroup B) Patients who are willing to discontinue maintenance therapy and continue monitoring. This subgroup will also include patients who have discontinued maintenance therapy earlier than 2 years due to side effects but also achieved sustained MRD negative CR might be also included. The number of the study participants will be limited by the number of patients treated in CUH who are meeting inclusion criteria.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma, Cancer, Hematologic Cancer
Keywords
Multiple Myeloma, Cancer

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be divided in the following groups: Group 1: Patients with biochemically detectable disease who have failed to achieve Complete remission (CR) or Very good Partial Remission (VGPR) by IMWG criteria and/or MRD-positive and/or high risk features. They will continue maintenance therapy until disease progression with monitoring every 3 months as per standard of care (SOC), or more often if required. Group 2: Patients in biochemical remission, who meet IMWG criteria for very good partial response (VGPR) or complete response (CR and and sustained MRD (defined as MRD-negative at two time points that are at least 1 year apart) without high risk features This group will be divided in the following subgroups: Subgroup A: Patients who prefer to continue on maintenance therapy. Maintenance will continue until disease progression. Subgroup B: Patients who prefer to discontinue maintenance therapy.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
No Intervention
Arm Description
Continuing Maintenance Therapy- Patients with biochemically detectable disease who have failed to achieve Complete remission (CR) or Very good Partial Remission (VGPR) by IMWG criteria and/or MRD-positive and/or high risk features. They will continue maintenance therapy until disease progression with monitoring every 3 months as per standard of care (SOC), or more often if required. In case of disease progression these patients will be switched to a different treatment and withdraw from the study. QOL will be assessed.
Arm Title
Group 2 Subgroup A
Arm Type
No Intervention
Arm Description
Continuing Maintenance Therapy- Patients in biochemical remission, who meet IMWG criteria for very good partial response (VGPR) or complete response (CR and and sustained MRD (defined as MRD-negative at two time points that are at least 1 year apart) without high risk features. High-risk cytogenetics abnormalities defined as per IMWG criteria (del(17p) and/or t(4;14) and/or t(14;16)) , or any other features suggestive of high risk disease: extramedullary disease, poor response to first line therapy, plasma cell leukaemia, organomegaly secondary to infiltration by multiple myeloma. Maintenance will continue until disease progression, monitored every 3 months as per SOC or more often if required. In case of disease progression these patients will be switched to a different treatment and withdraw from the study. QOL will be assessed.
Arm Title
Group 2 Subgroup B
Arm Type
Other
Arm Description
Patients who prefer to discontinue maintenance therapy. Patients who have discontinued maintenance therapy earlier than 2 years due to side effects but also achieved sustained MRD negative CR might be also included in this subgroup. This subgroup will be monitored and per SOC with blood tests, and BM MRD by NGF. In case of detectable disease in any of the samples (blood or BM) they will be offered to restart on maintenance therapy. Changing to a different type of treatment could be also offered to these patients, after discussion with treating physician. In case of being switched to a different treatment patient will withdraw from the study. QOL will be assessed
Intervention Type
Other
Intervention Name(s)
Discontinuation of maintenance treatment
Intervention Description
The discontinuation of maintenance treatment in multiple myeloma. Classed as interventional due to treatment being taken away.
Primary Outcome Measure Information:
Title
Number of participants that remain in sustained MRD negative remission by NGF in the bone marrow at 12 months after discontinuation of maintenance therapy.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Number of participants that remain in sustained MRD negative remission by NGF in the bone marrow at 24 months after discontinuation of maintenance therapy.
Time Frame
24 months
Title
Progression-free survival in multiple myeloma patients at 1 year in both groups of patients (on maintenance therapy and those who have discontinued)
Time Frame
1 year
Title
Progression-free survival in multiple myeloma patients at 2 years in both groups of patients (on maintenance therapy and those who have discontinued)
Time Frame
2 years
Title
Compare health-related quality of life between MM patients discontinuing versus continuing maintenance therapy using a QOL questionnaire
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years of age or over Patient with diagnosis of multiple myeloma as per IMWC in first line of treatment. Received at least 2 years of maintenance therapy, defined as any anti-myeloma therapy to prevent disease recurrence and prolong time in remission (i.e., lenalidomide) Patients who have discontinued maintenance therapy earlier than 2 years due to side effects but also achieved sustained MRD negative CR might be also included Patients must be able to understand and be willing to sign a voluntary informed consent form and agree to compliance with the protocol schedule, with the knowledge that they may withdraw consent at any time without impact on future medical care. Exclusion Criteria: Patients who have received more than one line of therapy or patients who have not completer two years of maintenance therapy, unless maintenance was discontinued voluntarily and the patient has achieved sustainable MRD negative remission. Patients with plasma cell disorders other than MM: lymphoplasmacytic lymphoma/Waldenstrom macroglobulinemia, AL amyloidosis, POEMS syndrome (Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal protein, and Skin changes), etc… Prior organ transplant or condition requiring immunosuppressive therapy. Prior allogenic haematopoietic cell transplant Treatment with any investigational therapy that does not include maintenance as a part of the treatment strategy. Unable to sign an informed consent form.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr Vitaliy Mykytiv
Phone
021-4920347
Email
vitaliy.mykytiv@hse.ie
Facility Information:
Facility Name
Cork University Hospital
City
Cork
Country
Ireland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Vitaliy Mykytiv
Phone
021-4920347
Email
vitaliy.mykytiv@hse.ie
First Name & Middle Initial & Last Name & Degree
Vitaliy Mykytiv
First Name & Middle Initial & Last Name & Degree
Micheal O'Meara
First Name & Middle Initial & Last Name & Degree
Aisling O' Brien

12. IPD Sharing Statement

Learn more about this trial

Lenalidomide Discontinuation Study

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