A phase II study of subcutaneous injection of bortezomib in combination with oral cyclophosphamide and dexamethasone (sVCD) for relapsed or refractory multiple myeloma

A phase II study of subcutaneous injection of bortezomib in combination with oral cyclophosphamide and dexamethasone (sVCD) for relapsed or refractory multiple myeloma - subcutaneous injection of bortezomib, oral cyclophosphamide and dexamethasone (sVCD) therapy for myeloma

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006490

Enrollment

Registered

2011-10-20

Start date

2011-11-01

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

relapsed or refractory multiple myeloma

Interventions

Bortezomib 1.3 mg/m2 on days 1, 8, 15 and 22, subcutaneous injection Cyclophosphamide 300 mg/m2 on days 1, 8, 15 and 22, orally Dexamethasone 40 mg daily on days 1, 8, 15 and 22, orally Each cycle

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male or female, aged > 20 years. 2. Give voluntary written informed consent before enrollment. 3. Relapse/refractory multiple myeloma in prior treatment. 4. At least 3 months life expectancy estimated at screening. 5. Possible to measure M protein in serum or urine. 6. Performance status 0-2. 7. Platelet counts > 75,000/mm3 8. Absolute neutrophil counts > 1500/mm3 9. AST and ALT < 2.5 times upper limit of normal standard 10. Bilirubin < 1.5 times of upper limit of normal standard 11. Serum Creatinine < 1.5 times of upper limit of normal standard 12. Ejection fraction is defined as > 50% 13. PaO2 > 60mmHg or SaO2 > 93% 14. Subject has a evidence of normal pulmonary finding by CT or X-Ray

Exclusion criteria

Exclusion criteria: 1. History of allergic reactions to compounds containing mannitol, bortezomib, or boron. 2. Poorly controlled hypertension, diabetes mellitus, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to study protocol. 3. Active infection requiring treatment 4. Active hepatitis B or C. 5. Under treatment for a cancer other than multiple myeloma 6. Impaired kidney function requiring dialysis, liver function, cardiac function or pulmonary function. 7. Non-secretory myeloma, plasmacytoma, plasma cell leukemia, and POEMS syndrome. 8. Peripheral neuropathy > grade 2 9. Pregnant, lactation or potential

Design outcomes

Primary

Measure	Time frame
The primary objective is to assess the efficacy of sVCD therapy for up to 6 cycles in patients with multiple myeloma who are relapsed or refractory to prior treatment.	—

Secondary

Measure	Time frame
The soconday objective is to assess the safety of subcutaneous injection of bortezomib and sVCD therapy.	—

Countries

Japan

Contacts

Public ContactYasushi Takamatsu

Fukuoka University Hospital Division of Medical Oncology, Hematology and Infectious Disease

yasushi@fukuoka-u.ac.jp81-92-801-2845

Outcome results

None listed

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