Efficacy and safety of response-adapted continuous daratumumab plus lenalidomide-dexamethasone therapy in combination with autologous stem cell transplantation for newly diagnosed multiple myeloma
- Conditions
- Multiple myeloma
- Registration Number
- JPRN-jRCTs071210074
- Lead Sponsor
- Kikushige Yoshikane
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 172
1) Cases in which the age at the time of registration is 20 to 65 years.
2) Cases of untreated multiple myeloma that meet the diagnostic criteria of IMWG.
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 FLC ratio is abnormal by FLC measurement.
4) Cases without major organ damage.
5) Cases in good general condition.
6) Survival of 3 months or more can be expected.
7) For female patients, it is agreed to use postmenopausal or surgical contraception or appropriate methods during the study period. For male patients, we have agreed to use appropriate methods of contraception during the study.
8) Written consent has been obtained for participation in this study.
1) Cases of smoldering and IgM myeloma, solitary plasmacytoma, plasmacytotic leukemia, POEMS syndrome, and Waldenstrom macroglobulinemia.
2) Cases with amyloidosis.
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) Cases in which myeloma cells infiltrate the central nervous system.
6) HIV antibody positive, HBs antigen positive, HCV antibody positive cases.
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 principal investigator or the investigator deems inappropriate.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of complete response (CR) or better (CR, sCR) after consolidation therapy
- Secondary Outcome Measures
Name Time Method