1601 study

JRCT ID: jRCTs041180048

Registered date:19/02/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Multiple myeloma
• Date of first enrollment: 13/05/2016
• Target sample size: 30
• Study type: Interventional

Intervention(s)

Bortezomib (subcutaneous injection, days 1,8) plus lenalidomide (days 1-14) dexamethasone (20mg/day, days 1,2,8,9) were administered for eight 21-cycles.
Dose of lenalidomide is adjusted according to the degree of renal failure.
Twelve cycle of Ld therapy is conducted following to the BLd therapy.

Outcome(s)

• Primary Outcome: objective response rate, very good PR (VGPR) above

Secondary Outcome

CR rate
overall response (PR above)
overall survival
progression-free survival
adverse event
treatment efficacy according to the translocation of chromosome myeloma related

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

1) Diagnosed as having symptomatic multiple myeloma
2) 65 years of age or more, under 80
3) Transplant in-eligible patients with 20 years or more and under 64 years.
4) Either menopausal women aged at 50 or older, women after hysterectomy, or women after bilateral ovariectomy. Females of childbearing potential must adhere to the guideline of the Revmate program.
5) Men who agreed to use contraception according to the guideline of the Revmate program.
6) ECOG performance status 0-2,or 3 due to osteolytic lesions alone
7) Having a measurable para-protein defined as serum monoclonal immunoglobulin concentration of at least 1.0g/dL of IgG, or at least 0.5g/dL of absolute serum concentration of IgA IgD, or urinary excretion of at least 0.2g of para-protein per 24 hours in spite of the type of myeloma. Measurable lesion of plasmacytoma, above diameter 5 cm, detected by CT scan.
8) No history of myeloma treatment. Transient administration of steroid is permitted
9) Absolute neutrophil count no less than 1000/mm3, platelet count no less than 75,000/mm3,
, AST/ALT no more than 100IU/L, total bilirubin 1.8 mg/dL or below, creatinine clearance 30 mL/min or above
SpO2 (room air) at least 94%, ECG neither ischemic change nor arrhythmia requiring medical intervention, cardiac ejection fraction at least 50%
10) Peripheral neuropathy (PN) within grade 2 without pain. Management of PN is permitted.
11) written informed consent by the patient

Exclude criteria

1) synchronous or metachronous malignancy
2) active infection or history of tuberculosis
3) severe constipation or ileus
4) interstitial pneumonia, pulmonary fibrosis
5) uncontrolled diabetes
6) inability to intake antithrombotic medication
7) pregnant or nursing women mellitus
8) uncontrollable hypertension
9) psychological disturbance
10) active double cancer
11) HBs-Ag positive or HCV-Ab positive or HIV-Ab positive
12) grade 3 or higher peripheral neuropathy, or grade 1 or higher neuralgia
13) glaucoma
14) primary plasma cell leukemia
15) no administration of blood transfusion or G-CSF within 7days before the treatment
16) no evidence of cardiac or intestinal amyloidosis
17) allergic history to borate or mannitol
18) Inappropriate case of the enrollment to this study judged by the attending physician

Related Information

• Primary Sponsor: RI MASAKI
• Source(s) of Monetary Support: Celgene K.K,Celgene K.K
• Secondary ID(s): UMIN000022008