New drugs for therapy in patients with newly diagnosed symptomatic multiple myeloma: a phase2 study -JSCT MM16-

JRCT ID: jRCTs071180019

Registered date:20/02/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Multiple myeloma
• Date of first enrollment: 08/03/2017
• Target sample size: 133
• Study type: Interventional

Intervention(s)

Induction therapy (4 courses, every 3 weeks)
scBor 1.3mg/m2 day1,4,8,11 + Len 25mg/body day1-14 + Dex 40mg/body day1,4,8,11

PBSC harvest
scBor 1.3mg/m2 day1,4,8,11 + CY 1.5g/m2 day8,9 + G-CSF

High dose chemotherapy and PBSCT
scBor 1.3mg/m2 day-4,-1,3,6 + HD-Mel 100mg/m2 day-3,-2 PBSCT day0

Consolidation therapy (4 courses, every 4 weeks)
Cfz 20/27mg/m2 day1,2,8,9,15,16 + Len 25mg/body day1-21 + Dex 40mg/body day1,8,15

Maintenance therapy (every 4 weeks until PD)
Len 10mg/day day1-21 until-PD

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 Treatment Failure (TTF)
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. Age from 20 to 65 years old.
2. Symptomatic multiple myeloma diagnosed by the criteria of International Myeloma Working Group (IMWG).
3. Measureable M protein in serum or urine or abnormal serum kappa/lambda ratio by the serum free light chain measurement.
4. Good performance status (0-2). (Patients with poor performance status by the osteolytic lesions can be included.)
5. Main Organ function is maintained
6. Those who are evaluated to be able to survive more than 3 months.
7. 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 according to the proposal of RevMate. For male patients, to agree the appropriate method of contraception during the study according to the proposal of RevMate.
8. 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: Miyamoto Toshihiro
• Secondary Sponsor: Akashi Koichi
• Source(s) of Monetary Support: Bristol-Myers Squibb Company,Bristol-Myers Squibb Company,ONO PHARMACEUTICAL CO., LTD
• Secondary ID(s): UMIN000024165