Phase II study of VCD therapy in patients with newly diagnosed, transplantation-eligible symptomatic multiple myeloma.

Phase II study of VCD therapy in patients with newly diagnosed, transplantation-eligible symptomatic multiple myeloma. - Shimousa MM-01 VCD study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000009750

Enrollment

Registered

2013-01-15

Start date

2012-11-01

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

Velcade

(Bortezomib) 1.3 mg/m2 (s.c.) Days 1, 4, 8, 11 (cycle 1) Days 1, 8, 15, 22 (cycle 2, 3, 4) + Cyclophosphamide 500 mg/m2 (div) days 1, 8 + Dexamethasone 20 mg (p.o. or div) Days 1, 2, 4, 5,

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Symptomatic multiple myeloma defined by IMWG criteria. 2.Measurable M protein in serum or urine 3.PS(ECOG)0-2.(Patients with poor P.S. by bone pain accompanying myeloma can be included.) 4.Age from 18 to 70 years old. 5.Main organ function is maintained 6.For female patients, postmenopausal (patients older than one year from the last menstrual period), or the proper way or surgical contraception (birth control pills, contraceptives, etc.) has the intention of contraception during the study. For male patients, to agree the appropriate method of contraception during the study. 7.voluntary written informed consent

Exclusion criteria

Exclusion criteria: 1. Non-secretory MM and plasmacell leukemia. 2. Patients with HIV antibody positive, HBs antigen posiive or HCV antibody positive 3. Severe hepatic dysfunction, severe renal failure, severe cardiac dysfunction, severe pulmonary dysfunction, uncontrolled diabetes, uncontrolled hypertension, and uncontrolled infection. 4. Patients with a history of active malignancy during the past 5 years. 5. Patients with psychiatric disorders such as schizophrenia etc. 6. Pregnant women, pre-menopausal women, and lactating women. 7. Patient was suspected pneumonia (Interstitial pneumonia). 8. Those who are considered as inappropriate to register by attending physicians.

Design outcomes

Primary

Measure	Time frame
CR/VGPR rate after 4 cycles of VCD therapy	—

Secondary

Measure	Time frame
1) Incidence of adverse events after 4 cycles of VCD therapy 2) Efficacy of peripheral blood stem cell harvest 3) Time to progression 4) Overall survival at two years after treatment 5) Treatment efficacy at two years after treatment 6) Incidence of adverse event at two years after treatment 7) Relationship between treatment efficacy at 4 cycles of VCD treatment and progression free survival (PFS)	—

Measure

Time frame

1) Incidence of adverse events after 4 cycles of VCD therapy 2) Efficacy of peripheral blood stem cell harvest 3) Time to progression 4) Overall survival at two years after treatment 5) Treatment efficacy at two years after treatment 6) Incidence of adverse event at two years after treatment 7) Relationship between treatment efficacy at 4 cycles of VCD treatment and progression free survival (PFS)

—

Countries

Japan

Contacts

Public ContactHisashi Wakita

Japanese Red Cross Society Narita Hospital Department of hematology and Oncology

mm01vcd@gmail.com0476-22-2311

Outcome results

None listed

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