W-JHS MM01

JRCT ID: jRCTs071180011

Registered date:04/01/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Multiple myeloma
• Date of first enrollment: 02/06/2017
• Target sample size: 80
• Study type: Interventional

Intervention(s)

1.Rd therapy (1-10 cycle):
Lenalidomide from day 1 to day 21 and dexamethasone at day 1, 8, 15 and 22 are administered (10 cycles, every 28 days)
2.Rd+Bor therapy (8 cycles):
Bortezomib is additionally sc administered on day1, 8, 15.
3.Lenalidomide maintenance therapy (every 28 day until PD): Lenalidomide 10mg/day, po (day 1 to 21)

Outcome(s)

• Primary Outcome: Complete response (CR) rate up to 18 cycles

Secondary Outcome

1. CR rate in the patients with additional administration of bortezomib.
2. Response rate up to 18 cycles.
3. Incidence of adverse events up to 18 cycles.
4. Progression free survival (PFS)
5. Overall survival (OS)
6. Progression free survival from enrollment to progression or death after second line regimen (judged by investigator)(PFS2)
7. Best response in second line regimen.
8. Evaluation of immune dynamics (degree of immune activation)
9. Evaluation of QOL.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Primary enrollment inclusion criteria
1) Patients are >= 20 years of age
2) Patients who understand the informed consent and can sign the informed consent form by his/her free will.
3) Patients who obey the protocol visit and other rules.
4) Newly diagnosed multiple myeloma.
5) Patients with following measurable M protein by protein electrophoresis analysis
6) Patients who cannot carry out hematopoietic stem cells transplantation.
7) ECOG PS 0,1 or 2
However,PS3 according to bone lesions are eligible.
8) Female childbearing patients who meet the following requirements
Patients who can agree to receive two times of pregnancy test before study drug administration
Patients who can agree to refrain completely from the sex with her partner or be effective contraception measures 28 days before study drug administration, during treatment period and 28 days after discontinuation of study drug administration.
9) Male patients who meet the following requirements:
Patients who can agree to completely refrains from the sex with his partner. 28days after discontinuation of study drug administration.
Patients who agree to not provide a seminal fluid and a sperm during treatment period and 28 days after the discontinuation of study drug administration.
10) Patients who meet the following requirements:
Understand the risk of teratogenicity of lenalidomide.
Can agree to not donate blood during the study drug administration and 28 days after study drug administration.

Secondary enrollment inclusion criteria
1) MM patients meeting all of the following three definitions.
Monoclonal bone marrow plasma cells >=10% or biopsy-proven plasmacytoma
Monoclonal protein (M protein) in serum or urine
any one or more of the following (1) and (2):
(1) Myeloma-related evidence of end organ damage
Hypercalcemia,Renal insufficiency,Anemia,Osteolytic lesion or osteoporosis
(2) Any one or more of the following definition.
60% or greater monoclonal plasma cells on bone marrow examination
Serum Free Light Chain >= 100
More than 2 focal lesions on MR

Exclude criteria

Primary enrollment exclusion criteria
1) Patients with severe disorder, laboratory test abnormality, mental disease.
2) Patient having a severe disease thought to be exposed to unacceptable risks if he/she participates in the study.
3) Patients who are in a state with the possibility to have an influence on the interpretation of the study data.
4) Patients with treatment history of myeloma.
5) Female patients with pregnancy or nursing.
6) Patients with following laboratory test abnormality.
Neutrophil < 1000/mm3
Platelet before transfusion < 50,000/mm3 (7 days passed after platelet transfusion)
AST or ALT > 3 X ULN
7) Patients with renal failure needed for hemodialysis or peritoneal dialysis.
8) Patients with anamnesis of malignant tumor other than MM
9) Patients who are or will not received antithrombotic therapy.
10) Patients with grade 2 or more peripheral neuropathy.
11) Patients with incontrollable systemic fungal/bacterial/viral infection
12) Patients with primary amyloidosis (AL) (immunoglobulin light chain) or myeloma with amyloidosis.
13) Patients not receiving dexamethasone or with contraindication of dexamethasone. 14) Patients not receiving bortezomib or with contraindication of bortezomib.

Secondary enrollment exclusion criteria
1) Patients met exclusion criteria after primary enrollment.
2) Patient who are confirmed for human immunodeficiency virus (HIV)-positive or treated.
3) Patients with hepatitis B virus (HBs antigen) positive or hepatitis C virus (HCV) antibody positive (if HBc antibody or HBs antibody is positive even if HBs antigen is negative, hepatitis B virus (HBV) DNA test is carried out. If HBV DNA is detected, The patients are excluded)
4) Any other patients who are regarded as unsuitable for this study by the investigators

Related Information

• Primary Sponsor: Shibayama Hirohiko
• Source(s) of Monetary Support: Bristol-Myers Squibb Company K.K.