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

Phase 2

• Conditions: Multiple myeloma

• Registration Number: JPRN-jRCTs071180019
• Lead Sponsor: Miyamoto Toshihiro

Brief Summary

Induction therapy with scVRD, ASCT with B-MEL, and consolidation with KRD resulted in profound responses and were well tolerated.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-20
• Study Completion: 2022-11-30
• Results First Posted: 2023-10-13
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 141

Inclusion 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.

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: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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