Back to resultsIntensified Treatment With Carfilzomib in Myeloma Patients Still PET-positive After First Line Treatment. (CONPET)
Primary Purpose
Myeloma
Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Carfilzomib
Lenalidomide
PET-CT
Dexamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Myeloma
Eligibility Criteria
Inclusion Criteria:
- Prior confirmed diagnosis of multiple myeloma (2014).
Received standard first line treatment with at least partial response. Standard first line treatment is defined as
- VRD, VTD or VCD followed by ASCT, or
- MPV at least 6 cycles, or no further reduction in monoclonal component the last 2 cycles, or
- Rd at least 9 cycles or no further reduction in monoclonal component the last 2 cycles.
- Carfilzomib naïve.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Absolute neutrophil count (ANC) ≥ 0,5 x 109/L) and platelet count >35 x 109/L.
- At least very good partial remission (VGPR) from first line treatment
Exclusion Criteria:
- Change of first line treatment because of stabile or progressive disease.
- Major surgery within 28 days before enrollment.
- Radiotherapy within 14 days before enrollment, but if the involved field is small, 7 days will be considered a sufficient interval before onset of the treatment.
- Glucocorticoid therapy within the 14 days prior to inclusion that exceeds a cumulative dose of 160 mg dexamethasone or 1000 mg prednisone.
- Central nervous system involvement.
- Uncontrolled heart disease, including congestive heart failure (NYHA III-IV), uncontrolled angina pectoris, uncontrolled conduction abnormalities, acute diffuse infiltrative pulmonary disease, pericardial disease or myocardial infarction within 6 months prior to enrollment
- Uncontrolled hypertension or uncontrolled diabetes despite medication
- Active hepatitis B or C infection or known human immunodeficiency virus (HIV) positivity.
- Another active malignancy. Patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
- Primary plasma cell leukemia, systemic AL amyloidosis, Waldenströms macroglobulinemia, POEMS syndrome
Sites / Locations
- Copenhagen University Hospital, Rigshospitalet
- Odense University Hospital
- Oslo University Hospital
- Skåne University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PET-CT-positive patients
Arm Description
Carfilzomib 20/36mg/m2 days 1,2,8,9,15,16 Lenalidomide 25mg days 1-21 Dexamethasone 40mg days 1,8,15,22 28 day cycles 4 cycles
Outcomes
Primary Outcome Measures
PET negativity after induction
How many of PET positive patients will become PET negative after treatment
Secondary Outcome Measures
PET correlation with MRD Euroflow
Before intervention all patients are PET-CT positive. The investigators will measure minimal residual disease (MRD) with immuno-flow cytometry, at the same timepoint, and describe how many of the PET-CT patients, are MRD-negative and how many are MRD-positive. After the intervention the investigators will again do PET-CT and MRD by flow cytometry. The investigators will then describe how many PET-positive patients are MRD-positive and how many are MRD-negative. As well, the investigators will describe the same in the PET-CT negative patients.
Full Information
NCT ID
NCT03314636
First Posted
September 8, 2017
Last Updated
May 4, 2023
Sponsor
Oslo University Hospital
Collaborators
Nordic Myeloma Study Group
1. Study Identification
Unique Protocol Identification Number
NCT03314636
Brief Title
Intensified Treatment With Carfilzomib in Myeloma Patients Still PET-positive After First Line Treatment.
Acronym
CONPET
Official Title
KRd Consolidation in Myeloma Patients With a Positive PET-CT After Standard First Line Treatment. A Phase II Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 16, 2018 (Actual)
Primary Completion Date
November 1, 2021 (Actual)
Study Completion Date
November 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
Nordic Myeloma Study Group
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A PET-CT will be performed on patients with myeloma after a standard first-line treatment. The PET-positive patients will receive 4 cycles of Carfilzomb-Revlimid-Dexamethason (KRd), before a new PET-CT will be performed.
Detailed Description
Patients will be evaluated for inclusion after finishing first-line therapy, or after a sufficient amount of treatment in first-line, and a sufficient respons (VGPR). Eligible performed regimens are defined in the protocol. All patients will perform a PET-CT, and PET-negative patients will be excluded from protocol treatment. The PET-positive patients will do a minimal residual disease (MRD-)evaluation in the bone marrow before entering treatment. After 4 28day cycles of Carfilzomib-Revlimid-Dexamethason, a new MRD and a new PET-CT will be performed, as measures of outcome. Patients will continue treatment as written in the protocol.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myeloma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PET-CT-positive patients
Arm Type
Experimental
Arm Description
Carfilzomib 20/36mg/m2 days 1,2,8,9,15,16 Lenalidomide 25mg days 1-21 Dexamethasone 40mg days 1,8,15,22 28 day cycles 4 cycles
Intervention Type
Drug
Intervention Name(s)
Carfilzomib
Intervention Description
See in arm description
Intervention Type
Drug
Intervention Name(s)
Lenalidomide
Intervention Description
See in arm description
Intervention Type
Device
Intervention Name(s)
PET-CT
Intervention Description
See in arm description
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
See in arm description
Primary Outcome Measure Information:
Title
PET negativity after induction
Description
How many of PET positive patients will become PET negative after treatment
Time Frame
1 month after induction
Secondary Outcome Measure Information:
Title
PET correlation with MRD Euroflow
Description
Before intervention all patients are PET-CT positive. The investigators will measure minimal residual disease (MRD) with immuno-flow cytometry, at the same timepoint, and describe how many of the PET-CT patients, are MRD-negative and how many are MRD-positive. After the intervention the investigators will again do PET-CT and MRD by flow cytometry. The investigators will then describe how many PET-positive patients are MRD-positive and how many are MRD-negative. As well, the investigators will describe the same in the PET-CT negative patients.
Time Frame
1 month after induction
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Prior confirmed diagnosis of multiple myeloma (2014).
Received standard first line treatment with at least partial response. Standard first line treatment is defined as
VRD, VTD or VCD followed by ASCT, or
MPV at least 6 cycles, or no further reduction in monoclonal component the last 2 cycles, or
Rd at least 9 cycles or no further reduction in monoclonal component the last 2 cycles.
Carfilzomib naïve.
Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
Absolute neutrophil count (ANC) ≥ 0,5 x 109/L) and platelet count >35 x 109/L.
At least very good partial remission (VGPR) from first line treatment
Exclusion Criteria:
Change of first line treatment because of stabile or progressive disease.
Major surgery within 28 days before enrollment.
Radiotherapy within 14 days before enrollment, but if the involved field is small, 7 days will be considered a sufficient interval before onset of the treatment.
Glucocorticoid therapy within the 14 days prior to inclusion that exceeds a cumulative dose of 160 mg dexamethasone or 1000 mg prednisone.
Central nervous system involvement.
Uncontrolled heart disease, including congestive heart failure (NYHA III-IV), uncontrolled angina pectoris, uncontrolled conduction abnormalities, acute diffuse infiltrative pulmonary disease, pericardial disease or myocardial infarction within 6 months prior to enrollment
Uncontrolled hypertension or uncontrolled diabetes despite medication
Active hepatitis B or C infection or known human immunodeficiency virus (HIV) positivity.
Another active malignancy. Patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
Primary plasma cell leukemia, systemic AL amyloidosis, Waldenströms macroglobulinemia, POEMS syndrome
Facility Information:
Facility Name
Copenhagen University Hospital, Rigshospitalet
City
Copenhagen
Country
Denmark
Facility Name
Odense University Hospital
City
Odense
Country
Denmark
Facility Name
Oslo University Hospital
City
Oslo
Country
Norway
Facility Name
Skåne University Hospital
City
Lund
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Intensified Treatment With Carfilzomib in Myeloma Patients Still PET-positive After First Line Treatment.
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