multiple myeloma
Conditions
Interventions
Induction therapy (both arm A and arm B) D-MPB therapy (every 3 weeks, 18 courses in total) First course (Daratumumab: 16 mg/kg (i.v.) or 1,800 mg/body (s.c.), day 1.8.15, Bortezomib: 1.3 mg/m2, day 1
Sponsors
MARUYAMA Dai
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: First registration criteria (1)At leaset one following Myeloma defining events of IMWG: (a) Hypercalcemia: serum calcium >11mg/dL. In case of serum albumin 2mg/dL (c) Anemia: hemoglobin valure =65 yeas old 2. 20 to 64 yeas old who refused high-dose chemotherapy followed by autologous stem-cell transplantation (5) Performance status: 0-2, or 3 due to osteolytic lesions alone (6) Having measurable paraprotein defined as serum monoclonal immunoglobulin concentration of at least 1000 mg/dL of IgG, or at least 500 mg/dL of absolute serum concentration of IgA/IgD, or urinary excretion of at least 200 mg of paraprotein per 24 hours regardless of the type of myeloma (7) Possible for a patient to receive maintenance therapy once every 2 weeks for 2 years, considering his/her geographical and social situation (8) Untreated for multiple myeloma except steroids for control of symptoms, bisphosphonate, denosumab, and radiotherapy for bone lesion (9) Peripheral neuropathy of grade 1 or less and no neuralgia (10) Sufficient organ function (assessed whithin 14 days prior to first registration): 1. Absolute neutrophil count >= 1,000/mm3, 2. Hemoglobin concentration >= 8.0 g/dL 3. Platelet count >= 75,000/mm3 4. Total bilirubin = 30 mL/min 8. SpO2 >= 94%(room air) (11) Cardiac ejection fraction >= 50% (assessed whithin 56 days prior to first registration) (12) ECG: neither ischemic change nor arrhythmia requiring new medical intervention (assessed whithin 56 days prior to first registration) (13) Consentto contraception (14) Written informed consent Second registration criteria (1) Completion of D-MPB therapy and achievement of PR and better (PR/VGPR/CR/sCR) according to the assessment of overall response within 28 days prior to second registration. In case of receiving 12 to 17 course of D-MPB therapy and PR and better, eligible if at least one or more criteria below are met: 1. Patients who want to discontinue D-MPB therapy, but want to start maintenance therapy. 2. Patients who meet the discontiation criteria of D-MPB therapy because of adverse events that are not associated with daratumumab and bortezomib (unlikely or unrelated) 3. Discontinuation of melphalan based on the criteria of dose modification due to adverse events (2) Performance status: 0-2 within 28 days prior to second registration (3) Either peripheral neuropathy of grade 2 or less and no neuralgia, or peripheral neuropathy of grade 1 or less and
Exclusion criteria
Exclusion criteria: (1) Simultaneous or metachronous (within 5 years) double cancers , with the exception of intramucosal tumor curable with local therapy. (2) Active infection requiring systemic therapy (3) Female during pregnancy, within 28 days of postparturition, or during lactation. Male who wants partner's pregnancy (4) Psychological disorder difficult to participate in this clinical study. (5) Receiving continuous systemic corticosteroid or immunosuppressant treatment for non-tumor disease such as collagen disease or autoimmune disease (6) Uncontrollable diabetes mellitus (7) Uncontrolled arterial hypertension (8) Uncontrolled chronic obstructive pulmonary disease and/or bronchial asthma (9) Positive HBs antigen or HCV antibody (10) Positive HIV antibody (11) Severe emphysema, interstitial pneumonia, pulmonary fibrosis or plueral effusion trated with thoracentesis for symptom relief based on chest CT (12) Uncontrolled glaucoma (13) Drug allergy for boron or mannitol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival after second registration | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival (OS) after first registration, OS after second registration, time to next treatment (TNT) from first registration, TNT from second registration, progression-free survival after first registration, progression-free survival after next-line therapy, response rate of induction therapy, proportion of MRD-negative status for 12 months or over, improvement of response rate during maintenance therapy, adverse events, severe adverse events, completion of induction therapy, completion of maintenance therapy, dose intensity | — |
Contacts
Public ContactDai MARUYAMA
The Cancer Institute Hospital Of JFCR
Outcome results
None listed