A multicenter phase II study to evaluate the efficacy and safety of fixed-duration sequential treatment combined with novel agents and autologous stem cell transplantation for newly diagnosed elderly multiple myeloma. -JSCT EMM21
- Conditions
- Multiple myeloma
- Registration Number
- JPRN-jRCTs071210084
- Lead Sponsor
- Kikushige Yoshikane
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 75
1) Patients who are 66 years old or older and 75 years old or younger at the time of registration and fit.
2) Cases of multiple myeloma that meet the diagnostic criteria of IMWG (revised in 2014).
3) M protein, which is an index for determining the therapeutic effect, can be measured in serum or urine. Or, a case in which the serum free light chain concentration ratio is abnormal in the serum free light chain measurement.
Serum M protein is 1g / dL or more
Urinary M protein is 200 mg or more after 24hour urine storage
The free light chain concentration ratio in serum is abnormal and the free light chain concentration is 100 mg / L or more.
4) Cases without major organ damage.
5) Cases in which the general condition is good (ECOG Performance Status; PS is 0 to 2).
6) For female patients, contraceptive during the study period after menopause (patients who have passed more than one year since the last menstrual period) or by observing RevMate and using surgical contraception or appropriate methods (contraceptives, contraceptives, etc.) I have agreed to do so. For male patients, we adhere to RevMate and agree to use appropriate contraception during the study.
7) Patients who have been notified have received sufficient explanation from the doctor in charge about the contents of this study using explanatory documents, and have voluntarily agreed to participate in this study in writing.
1) Cases of smoldering and IgM myeloma, solitary plasmacytoma, plasmacytotic leukemia, POEMS syndrome, and Waldenstrom macroglobulinemia.
2) Cases with symptoms due to amyloidosis and histologically proven amyloid deposits
3) Patients who underwent surgery or radiation therapy within 14 days before registration.
4) Patients who received more than 30 mg / day in terms of prednisolone within 14 days before registration.
5) Patients with central nervous system infiltration of myeloma cells.
6) HIV antibody positive, HBs antigen positive, HCV-PCR positive (HCV-PCR negative patients are possible).
7) Cases with uncontrolled liver dysfunction, renal dysfunction, cardiac dysfunction, pulmonary dysfunction, diabetes, hypertension, and infectious diseases.
8) Active and advanced stage double cancer cases
9) Cases with severe psychiatric disorders such as schizophrenia.
10) Pregnant women and cases who may become pregnant during the study period or are breastfeeding.
11) If the SARS-CoV2 test is found to be positive before the case registration, cases in which the symptoms have not disappeared and cases within 30 days after the positive judgment are excluded.
12) Other cases that the doctor in charge judged to be inappropriate.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method