None listed
Conditions
Interventions
Drug : VRd Induction therapy (Maximum 6 cycles) – ASCT – VRd Consolidation therapy (2 cycles)
1) VRd Induction therapy: 4 weeks interval, maximum 6 cycles
- Bortezomib: 1.3 mg/m2/SC or IV on day 1
Sponsors
The Catholic University of Korea, Seoul St. Mary's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Newly diagnosed multiple myeloma (2) Age =19 years old and 1 g/dL) and 24 hours urine (>0.2 g/24 hour) M-protein (5) Eastern Cooperative Oncology Group Performance Status 0-2 (6) Adequate hematological counts, kidney, liver, and cardiac function a. ANC > 1.5 x 109/L and platelet count > 75 x 109/L unless due to bone marrow involvement b. Creatinine clearance = 50 mL / min (calculated by Cockcroft-Gault formula) c. ALT, AST = 2 x UNL, Total bilirubin = 2 x UNL d. Cardiac ejection fraction (MUGA scan or echocardiography) = 45% (7) Patients who decided to voluntarily participate in the study and agreed with informed consent (8) Eligible patients with autologous stem cell transplantation (9) Female patients who: a. Are naturally postmenopausal for at least 2 year before enrolment b. Are surgically sterile c. In the case of a pregnant woman, the pregnant woman must agree on the following: i. adhere to the lenalidomide pregnancy prevention risk management program in Appendix 6 ii. All women of childbearing potential must agree to have two negative pregnancy test within 10-14 days and 24hrs before commencing lenalidomide and use two reliable methods of contraception simultaneously or practice complete abstinence from any heterosexual intercourse during the following time periods related to this study: 1) for at least 28 days before starting study; 2) while participating in the study; 3) dose interruptions; and 4) for at least 28 days after study treatment discontinuation. The two methods of reliable contraception must include one highly effective method and one additional effective method to prevent pregnancy, not plan on conceiving children during or within 6 months following lenalidomide. (See Appendix E Pregnancy Prevention and Risk Management Program). (10) Male patients, even if surgically sterilized (i.e. status post-vasectomy), who: a. Agree to practice effective barrier contraception during the entire study treatment period and through 28 days after the last dose of study treatment b. Agree to completely abstain from heterosexual intercourse c. Must also adhere to the guidelines of the lenalidomide pregnancy prevention and risk management program
Exclusion criteria
Exclusion criteria: (1) Primary amyloidosis, Smoldering myeloma, Solitary plasmacytoma, monoclonal gammopathy with undetermined significance (MGUS) (2) Prior chemotherapy for multiple myeloma (3) Secondary malignant tumor within last 5 years. The following are exceptions: properly treated squamous cell and basal cell carcinoma of the skin, carcinoma in situ of the cervix (5) Patients with peripheral neuropathy = Grade 2(NCI-CTCAE version 5) (6) Patients with HIV positive (7) Patients with active hepatitis B or C infection (8) Patients with uncontrolled diabetes (9) Have received an experimental drug or used an experimental medical device within 4 weeks before the planned start of treatment. Concurrent participation in non-treatment studies is allowed, if it will not interfere with participation in this study. 10) Hypersensitivity for bortezomib and its Ingredients 11) Hypersensitivity for lenalidomide and its Ingredients 12) Hypersensitivity for dexamethasone and its Ingredients 13) Patients with acute interstitial lung disease or pericarditis 14) Patients with genetic problems such as galactose intolerance, Lapp lactose dehydrogenase deficiency or glucose-galactose uptake disorder 15) Patient with live vaccine injected 16) Patients with Herpes simplex, herpes zoster, varicella infection 17) Infection without effective antimicrobial agent or systemic fungal infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of Very good partial response (VGPR) or better | — |
Secondary
| Measure | Time frame |
|---|---|
| Drug toxicity and side effects;Amount of hematopoietic stem cell collection;Complete remission rate;Complete remission rate;Overall survival rate;Progression free survival rate | — |
Countries
Korea, Republic of
Contacts
Public ContactDae Sik Kim
Koera University Guro Hospital
Outcome results
None listed