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A multi-center, prospective, non-randomized clinical study of bortezomib / thalidomide, cyclophosphamide and dexamethasone combined with autologous hematopoietic stem cell transplantation in patients with de novo advanced multiple myeloma

A multi-center, prospective, non-randomized clinical study of bortezomib / thalidomide, cyclophosphamide and dexamethasone combined with autologous hematopoietic stem cell transplantation in patients with de novo advanced multiple myeloma

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-ONRC-13003502
Enrollment
Unknown
Registered
2013-08-22
Start date
2013-09-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Multiple Myeloma

Interventions

PCD chemo group:Chemotherapy
PCD plus ASCT group:Chemotherapy plus ASCT
TCD chemo group:Chemotherapy
TCD plus ASCT group:Chemotherapy plus ASCT

Sponsors

The First Affiliated Hospital of Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. aged 18 years to 70 years; 2. In accordance with IMWG2003/WHO 2008 (V4) MM diagnostic criteria and with measurable indicators; 3. The eastern cooperative oncology group fitness score (ECOG) =10g/L and/or 24-hour urine M protein >=200mg; 5. No active infectious diseases; 6. The main organs without serious organic disease (except for renal dysfunction, caused by the disease); 7. The patients have signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. The patients have received anti-myeloma therapy (not including radiotherapy, bisphosphonate therapy, or a single short-term glucocorticoidshormone [i.e., less than or equal to prednisone 40mg / day, 5 day dose]); 2. The patients appear pain or peripheral neuropathy with two or more degree; 3. The patients have a serious thrombotic events; 4. The patients have a major surgery in 30 days; 5. The patients have other malignancy, unless the disease are in a stable situation for more than 3 years; 6. The patients are on borate, mannose, and thalidomide allergies; 7. The patients have serious infectious diseases (not cured tuberculosis, pulmonary aspergillosis); 8. The patients have epilepsy, dementia and other mental health exception demanding drug treatment; 9. There are some stats in the subjects may effect the study or study assessing (i.e., drug abuse, or other medical, psychological or social status); 10. The researchers believe that those who do not fit into this trial.

Design outcomes

Primary

MeasureTime frame
Allover response rate;Complete response rate;Safety;

Secondary

MeasureTime frame
Disease free survival;Progression free survival;Overall survival;

Countries

China

Contacts

Public ContactZhen Cai
caizhen1@yahoo.com+86 13857190311

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026