ewly diagnosed multiple myeloma: a phase2 study -JSCT-MM14
- Conditions
- Multiple myeloma
- Registration Number
- JPRN-jRCTs071180034
- Lead Sponsor
- Sunami Kazutaka
- Brief Summary
The study treatment was in some degree effective, but the complete remission after scVRD fell short of the threshold we set. Induction with 4 cycles of scVCD, auto-PBSCT with Bor plus high-dose MEL, and consolidation with scVRD were highly tolerable, despite being intensified treatments.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 55
1. Multiple myeloma diagnosed by the criteria of International Myeloma Working Group (IMWG). Age from 20 to 65 years old.
2. Measureable M protein in serum or urine or abnormal serum k/l ratio by the serum free light chain measurement.
3. Good performance status (0-2). (Patients with poor performance status by the osteolytic lesions can be included.)
4. Main Organ function is maintained
5. Those who are evaluated to be able to survive more than 3 months.
6. For female patients, postmenopausal (patients older than one year from the last menstrual period), or the proper way or surgical contraception (birth control pills, contraceptives, etc.) has the intention of contraception during the study. For male patients, to agree the appropriate method of contraception during the study.
7. In patients receiving the notice, fully briefed for the consent document and other documents given explanation about the contents of the study physician or study investigator, agreed in writing to voluntarily participate in the study by having been obtained.
1. Non-secretory MM, plasma cell leukemia, POEMS syndrome, and Waldenstrom Macroglobulinemia.
2. Patients with amyloidosis.
3. Patients who have been undergoing surgery or radiation treatment within 14 days before participating the study.
4. Patients who received prednisolone more than 30mg/day within 14 days before participation.
5. Involvement of central nervus system with myeloma cells
6. Patients HIV-positive, HBs antigen positive, and HCV antibody positive (except HCV-PCR negative).
7. Severe hepatic dysfunction, severe renal failure, severe cardiac dysfunction, severe pulmonary dysfunction, uncontrolled diabetes, uncontrolled hypertension, and uncontrolled infection.
8. Patients with a history of active malignancy during the past 5 years.
9. Patients with psychiatric disorders such as schizophrenia etc.
10. Pregnant women, pre-menopausal women, and lactating women.
11. History of hypersensitivity to mannitol or boron.
12. Patient was suspected pneumonia (Interstitial pneumonia). Consult a respiratory specialist if necessary
13. Those who are considered as inappropriate to register by attending physicians.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Complete response (CR) rates after consolidation therapy.
- Secondary Outcome Measures
Name Time Method 1. CR + stringent CR (sCR) rates after induction therapy. <br>2. CR + sCR rates after autologous stem cell transplantation. <br>3. sCR rates after consolidation therapy. <br>4. CR + sCR rates after maintenance therapy. <br>5. 3-years progression free survival (PFS) <br>6. 3-years overall survival (OS) <br>7. 3-years time to progression (TTP) <br>8. Incidence of adverse events. <br>9. Molecular complete response (mCR) rates after autologous stem cell transplantation, consolidation and maintenance therapy. <br>10. Detection of minimal residual disease (MRD) in autologous grafts.