Status:
ACTIVE_NOT_RECRUITING
Intensified Treatment With Carfilzomib in Myeloma Patients Still PET-positive After First Line Treatment.
Lead Sponsor:
Oslo University Hospital
Collaborating Sponsors:
Nordic Myeloma Study Group
Conditions:
Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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-C...
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 d...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2026
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT03314636
Start Date
March 16 2018
End Date
November 1 2026
Last Update
August 8 2025
Active Locations (4)
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1
Copenhagen University Hospital, Rigshospitalet
Copenhagen, Denmark
2
Odense University Hospital
Odense, Denmark
3
Oslo University Hospital
Oslo, Norway
4
Skåne University Hospital
Lund, Sweden