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In Korea, VMP is most commonly used as frontline treatment in patients with newly diagnosed MM who were ineligible for high-dose therapy. Recently National Insurance began to reimburse the second-line LD when the bortezomib-containing treatment failed to salvage the patients. Patients who have relapsed MM after exposure to the above agents and have progressive disease have a short life expectancy. Third-line therapy is needed for retrieving the patients hereafter. And substantial proportion of patients will attain an advanced age. To examine if time to disease progression is maintained and tolerability is improved with lower dexamethasone dose, the dose of dexamethasone is reduced when at least a minimal response is achieved after 3 months of treatment with the initial dose. Three months later (6 months after the initial treatment), the response remains in stable disease, 2nd dose reduction (dexamethasone 10mg or prednisone 50mg) will be carried out.
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Inclusion criteria
Patients must have evaluable multiple myeloma with at least one of the following (within 21 days of starting treatment)
Patients were ineligible for autologous stem cell transplantation
Must be relapse refractory to initial therapy with bortezomib, melphalan and prednison and then lenalidomide plus dexamethasone.
Refractoriness is defined as disease progression on treatment or progression within 6 months after the last dose of a given therapy. Relapse is defined according to the criteria of IMWG
Males and females ≥ 18 years of age or > country's legal age for adult consent
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
Patients must meet the following clinical laboratory criteria with 21 days of starting treatment:
Written informed consent in accordance with federal, local and institutional guidelines
Exclusion criteria
Female patients who are lactating or pregnant
Multiple Myeloma of IgM subtype
Glucocorticoid therapy (prednisolone > 30mg/day or equivalent) within 14 days prior to informed consent obtained
POEMS syndrome, plasma cell leukemia or circulating plasma cells ≥ 2 x 109/L, Waldenstrom's Macroglobulinaemia, or Patients with known amyloidosis
Peripheral neuropathy grade > 2
Chemotherapy with approved or investigation anticancer therapeutics within 21 days prior to starting pomalidomide treatment
Focal radiation therapy within 7 days prior to start of pomalidomide. Radiation therapy to an extended field involving a significant volume of bone marrow within 21 days prior to start of pomalidomide
Immunotherapy (excluding steroids) 21 days prior to start of pomalidomide
Major surgery (excluding kyphoplasty) within 28 days prior to start of pomalidomide
Active congestive heart failure (New York Heart Association [NYHA] Class III or IV), symptomatic ischaemia, or conduction abnormalities uncontrolled by conventional intervention. Myocardial infarction within 4 months prior to informed consent obtained
Known HIV seropositive, hepatitis C infection, and/or hepatitis B (except for patients with hepatitis B surface antigen or core antibody receiving and responding to antiviral therapy directed at hepatitis B: these patients are allowed)
Second malignancy within the past 3 years except:
Patients with steroid or lenalidomide hypersensitivity
Patients with pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to starting pomalidomide treatment
Any clinically significant medical disease or psychiatric condition that, in the investigator's opinion, may interfere with protocol adherence or a patient's ability to give informed consent
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55 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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