Newly diagnosed multiple myeloma: a phase2 study -JSCT-MM14- (JSCT MM14)

Completed

• Conditions: Multiple myeloma

• Registration Number: jRCTs071180034

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08-11
• Study First Submitted: 2019-03-08
• Last Update Posted: 2021-01-25

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

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.

Exclusion Criteria

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: single assignment

Primary Outcome Measures

Name	Time	Method
-		Complete response (CR) rates after consolidation therapy.

Secondary Outcome Measures

Name	Time	Method
CR + stringent CR (sCR) rates after induction therapy		CR + stringent CR (sCR) rates after induction therapy
CR + sCR rates after autologous stem cell transplantation		CR + sCR rates after autologous stem cell transplantation
sCR rates after consolidation therapy		sCR rates after consolidation therapy
CR + sCR rates after maintenance therapy		CR + sCR rates after maintenance therapy
3-years progression free survival (PFS)	3-years	3-years progression free survival (PFS)
3-years overall survival (OS)	3-years	3-years overall survival (OS)
3-years time to progression (TTP)	3-years	3-years time to progression (TTP)
Incidence of adverse events		Incidence of adverse events
Molecular complete response (mCR) rates after autologous stem cell transplantation, consolidation and maintenance therapy		Molecular complete response (mCR) rates after autologous stem cell transplantation, consolidation and maintenance therapy
Detection of minimal residual disease (MRD) in autologous grafts		Detection of minimal residual disease (MRD) in autologous grafts