Phase II study of induction therapy with subcutaneous bortezomib, oral melphalan and predonisone for newly diagnosed multiple myeloma patients ineligible for stem cell transplantation

Phase II study of induction therapy with subcutaneous bortezomib, oral melphalan and predonisone for newly diagnosed multiple myeloma patients ineligible for stem cell transplantation - Phase II study of MP plus subcutaneous bortezomib for newly diagnosed multiple myeloma patients ineligible for stem cell transplantation

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010401

Enrollment

Registered

2013-04-03

Start date

2013-03-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Multiple Myeloma

Interventions

MPB(subcutaneous bortezomib, oral melphalan and predonisone) treatment

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All the following criteria MUST be met: 1)Symptomatic multiple myeloma in IMWG diagnostic criteria 2)Newly diagnosed multiple myeloma patients ineligible autologous stem cell transplantation 3)Multiple myeloma received NO prior treatment 4)Measurable disease: serum IgG >=1.0 g/dL; IgA, IgD protein >=0.5 g/dL; urinary M-protein excretion 0.2 g/ 24 hour 5)Age >=20 year old and <=80 year old 6)PS 0-2 or 3 by osteolytic lesion 7)All the following criteria MUST be met: Neutrophil >=1000 /mm3 Platelet >=75000 /mm3 hemoglobin >=8.0 g/dl Serum AST or ALT <=2.5 x ULN Serum total bilirubin <=2.0mg/dl Serum creatinine <=2.5mg/dl Compensated serum Ca <=12.5 mg/dl Serum Na >130 mEq/l ECG: normal or asymptomatic and required no treatment Ejection fraction >=50% SpO2 >=95% 8)Prognosis more than 3 months 9)Given voluntary written consent for this study

Exclusion criteria

Exclusion criteria: 1)Women in pregnancy or lactation; women who can not or intend to use appropriate contraceptive methods 2)Active and advanced cancer 3)steroid administration equivalent to 10mg prednisolone for other disease 4)psychiatric disease or psychological symptom 5)Positive for HBs antigen or able to detect HBV DNA 6)Positive for HCV antibody 7)Positive for HIV antibody 8)poorly controlled diabetes mellitus 9)poorly controlled hypertension 10)Cardiac amyloidosis 11)Angina; acute myocardial infarction last 6 months; heart failure or arrythmia that needs treatment 12)Interstitial pneumonia, pulmonary fibrosis, severe pulmonary emphysema or pleural effusion that allows aspiration 13)Peripheral neuropathy Grade >=2; painful peripheral neuropathy 14)Severe drug allergy 15)The patient judged inappropriate to participate in this study

Design outcomes

Primary

Measure	Time frame
complete response rate	—

Secondary

Measure	Time frame
overall response rate, progression free survival, overall survival, incidence rate of adverse events, rate of complete treatment	—

Countries

Japan

Contacts

Public ContactDaisuke Ogiya

Tokai University School of Medicine Department of Hematology/ Oncology

giya_pen_1213.0@triton.ocn.ne.jp0463-93-1121

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026