Intensified Treatment With Carfilzomib in Myeloma Patients Still PET-positive After First Line Treatment.

Prior treatment

• 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.
• 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

Other illness

• Change of first line treatment because of stabile or progressive disease.
• 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

Other

• Central nervous system involvement.

• 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