Clinical trial to evaluate efficacy and safety of cyclophosphamide, bortezomib and dexamethasone (CBD) induction and autologous stem cell transplantation for patients for newly diagnosed multiple myeloma (NBMT-ASCT1201)

Clinical trial to evaluate efficacy and safety of cyclophosphamide, bortezomib and dexamethasone (CBD) induction and autologous stem cell transplantation for patients for newly diagnosed multiple myeloma (NBMT-ASCT1201) - CBD induction and ASCT for patients with newly diagnosed MM patients (NBMT-ASCT1201)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008399

Enrollment

Registered

2012-07-23

Start date

2012-08-01

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

A line of therapy composed of induction, autologous peripheral stem cell harvest (ASCH), high-dose chemotherapy (HDT)+autologous stem cell transplantation(ASCT), consolidation, and maintenance therapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. multiple myeloma defined by IMWG criteria 2. symptomatic multiple myeloma defined by IMWG 3. no previous anti-myeloma chemotherapy 4. aged >20 and <65 5. PS(ECOG) 0-2 6. existence of measurable disease (one of the following) 1) serum M protein > 1g/dL 2) 24-hr urine M protein > 200 mg 7. voluntary written informed consent

Exclusion criteria

Exclusion criteria: 1. multiple myeloma defined by IMWG criteria 2. symptomatic multiple myeloma defined by IMWG 3. no previous anti-myeloma chemotherapy 4. aged >20 and <65 5. PS(ECOG) 0-2 6. existence of measurable disease (one of the following) 1) serum M protein > 1g/dL 2) 24-hr urine M protein > 200 mg 7. voluntary written informed consent 1. plasma cell leukemia 2. severe renal damage: serum Cr > grade 3 even after correction of dehydration and hypercalcemia 3. severe cardiac dysfunction 1) LEVF < 50% 2) angina pectoris or acute myocardial infarction within 6 months of enrollment 3) congestive heart failure requiring medical treatment 4) arrhythmia requiring medical treatment. 4. severe respiratory dysfunction 1) SpO2 < 92% 2) interstitial pneumonitis 3) Chronic Obstructive Pulmonary Disease 4) active pneumonia 5. sever liver dysfunction 1) AST,ALT elevation > grade 2 (5xULN) 2) Total bilirubin elevation > grade 2 (3xULN) 6. infection 1) HIV positive 2) HBs antigen positive 7. peripheral neuropathy > grade 2 8. poor controlled diabetes mellitus even after treatment, having one or more of the following 1) HbA1c >8.0%, 2)fasten blood sugar > 160 mg/dL, 3) blood sugar after 2h of eating > 220 mg/dL 9. others 1) active opportunistic infection 2) active double cancer 3) doctor judged adequate to enroll the study

Design outcomes

Primary

Measure	Time frame
3-year progression free survival	—

Secondary

Measure	Time frame
1.incidence of adverse events 2.incidence of therapy related mortality 3. pretreatment risk factors for prognosis 1) ISS 3, 2) serum LDH level, 3) cytogenetic abnormality, 4) t(4;14), t(14;16) or deletion of 17q proved by FISH analysis 4. treatment response 1) after CBD induction, 2) 12 weeks after ASCT 3)after consolidation, 4) after maintenance, and 5)at best response 5.time to progression 6. relapse free survival 7. overall survival 8. incidence of secondary primary malignancy 9.impact of response on prognosis 1) pre high-dose therapy, 2) post high dose therapy, 3) post consolidation	—

Measure

Time frame

1.incidence of adverse events 2.incidence of therapy related mortality 3. pretreatment risk factors for prognosis 1) ISS 3, 2) serum LDH level, 3) cytogenetic abnormality, 4) t(4;14), t(14;16) or deletion of 17q proved by FISH analysis 4. treatment response 1) after CBD induction, 2) 12 weeks after ASCT 3)after consolidation, 4) after maintenance, and 5)at best response 5.time to progression 6. relapse free survival 7. overall survival 8. incidence of secondary primary malignancy 9.impact of response on prognosis 1) pre high-dose therapy, 2) post high dose therapy, 3) post consolidation

—

Countries

Japan

Contacts

Public ContactIsamu Sugiura

Toyohashi Municipal Hospital Division of Hematology and Oncology

sugiura-isamu@toyohashi-mh.jp0532-33-6111

Outcome results

None listed

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