Bortezomib with lenalidomide and dexamethasone combination as induction therapy in transplantation candidate patients with newly diagnosed multiple myeloma

Not Applicable

Terminated

• Conditions: Neoplasms

• Registration Number: KCT0004005
• Lead Sponsor: The Catholic University of Korea, Seoul St. Mary's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: Terminated
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

(1) Newly diagnosed multiple myeloma
(2) Age =19 years old and <65 years old
(3) Untreated patients
(4) Measurable serum (>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

(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

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of Very good partial response (VGPR) or better

Secondary Outcome Measures

Name	Time	Method
Drug toxicity and side effects;Amount of hematopoietic stem cell collection;Complete remission rate;Complete remission rate;Overall survival rate;Progression free survival rate