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

JRCT ID: jRCTs071180034

Registered date:08/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Multiple myeloma
• Date of first enrollment: 11/08/2015
• Target sample size: 53
• Study type: Interventional

Intervention(s)

Induction therapy (4 courses, every 3 weeks):Bortezomib 1.3mg/m2 sc (day1,4,8,11), cyclophosphamide 500mg/m2 iv (day1, 8), dexamethasone 40mg/day po (day 1,4,8, 11).

PBSC harvest: Bortezomib 1.3mg/m2 sc (day1, 4, 8, 11). Cyclophosphamide 1.5g/m2 div (day 8, 9). G-CSF

High dose chemotherapy and PBSCT: Bortezomib 1.3mg/m2 sc (day-4,-1,3,6). HD-melphalan 100mg/m2 div (day -3,-2). PBSCT (day 0)

Consolidation therapy (2 courses, every 4 weeks): Bortezomib 1.3mg/m2 sc (day1, 8, 15), lenalidomide 25mg/body po (day1-21), and dexamethasone 40mg/day po (day1, 8, 15,22).

Maintenance therapy (every 4 weeks until PD): Lenalidomide 10mg/day po (day 1 to 21)

Outcome(s)

• Primary Outcome: Complete response (CR) rates after consolidation therapy.

Secondary Outcome

1. CR + stringent CR (sCR) rates after induction therapy.
2. CR + sCR rates after autologous stem cell transplantation.
3. sCR rates after consolidation therapy.
4. CR + sCR rates after maintenance therapy.
5. 3-years progression free survival (PFS)
6. 3-years overall survival (OS)
7. 3-years time to progression (TTP)
8. Incidence of adverse events.
9. Molecular complete response (mCR) rates after autologous stem cell transplantation, consolidation and maintenance therapy.
10. Detection of minimal residual disease (MRD) in autologous grafts.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 65age old
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Sunami Kazutaka
• Secondary Sponsor: Akashi Koichi
• Source(s) of Monetary Support: Celgene K.K.,Celgene K.K.
• Secondary ID(s): UMIN000016440