Phase II trial of bortezomib, lenalidomide, and dexamethasone in patiens with high-risk smoldering myeloma

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0006266

Enrollment

Registered

2021-06-17

Start date

2021-12-16

Completion date

Unknown

Last updated

2025-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : [19~65years] D1, 4, 8, 11 Bortezomib 1.3 mg/m2 subcutaneous injection D1 – 14 Lenalidomide 25 mg P.O. D1, 2, 4, 5, 8, 9, 11, 12 Dexamethasone 20 mg IV or PO [66~75years] D1, 4, 8, 11 Bortezo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Age 19~75 2.High-risk smoldering multiple myeloma (2~3 of the followings) - serum M-protein = 2 g/dL - Serum free light chain ratio (involved/uninvolved) = 20 - Bone marrow plasma cells = 20% 3.Adequate organ function - Absolute neutrophil count = 1.0 x 109/L - Platele = 50 x 109/L (= 30 x 109/L if myeloma involvement is > 50% in the bone marrow) - Hemoglobin = 8.0 g/dL (?? ??) - Creatinine clearance = 30 mL/minute - Bilirubin ???? = 1.5 x upper normal limit - AST and ALT = 3 x upper normal limit 4.Eastern Cooperative Oncology Group performance scale 0, 1 or 2 5.Expected survival > 3 months 6.Well-controlled HBV or HCV infection 7.Written informed consents

Exclusion criteria

Exclusion criteria: Active multiple myeloma 2. Low-intermediate risk SMM 3. Monoclonal gammopathy of undetermined significance 4. Prior treatment for SMM 5. Pregnant or lactating women 6. Myocardial infarct within 6 months, heart failure of NYHA Class III~IV, uncontrolled ventricular arrhythmia, history of severe coronary arterial disease 7. Uncontrolled hypertension or diabetes 8. Neuropathy grade 3~4 9. HIV infection 10. Patients with severe or uncontrolled medical conditions, abnormal laboratory findings, or psychiatric disorders 11. Hypersensitivity to the investigational products 12. Synchronous or metachronous malignant tumor other than SMM within 5 years (except for adequately treated basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) of the skin, adequately resected differentiated thyroid cancer, intraepithelial carcinoma of the neck or breast, or prostate cancer that can be monitored for progress status without any treatment).

Design outcomes

Primary

Measure	Time frame
2-year progression free survival rate	—

Secondary

Measure	Time frame
Overall response rate, complete response rate, progression free survival1 (time to MM development), progression free survival2 (progression free survival after starting definite treatment for active myeloma), overall survival, minimal residual disease negative convertion rate	—

Countries

Korea, Republic of

Contacts

Public ContactJEJUNG LEE

Chonnam National University Hospital Hwasun Hospital

gchoi7855@nate.com+82-61-379-7855

Outcome results