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Prospective Randomized controlled study of the combination regimen of bortezomib + thalidomide + dexamethasone (VTD) and bortezomib + cyclophosphamide + dexamethasone (VCD) for the initial treatment of type AL amyloidosis

Prospective Randomized controlled study of the combination regimen of bortezomib + thalidomide + dexamethasone (VTD) and bortezomib + cyclophosphamide + dexamethasone (VCD) for the initial treatment of type AL amyloidosis

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-17012637
Enrollment
Unknown
Registered
2017-09-11
Start date
2017-10-01
Completion date
Unknown
Last updated
2017-10-02

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

Conditions

type AL amyloidosis

Interventions

Group 1:the combination regimen of bortezomib +thalidomide + dexamethasone (VTD)
Group 2:the combination regimen of bortezomib + cyclophosphamide + dexamethasone (VCD)

Sponsors

Guangdong General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) signed a written informed consent; (2) aged between 18 and 75 years male or female; (3) primary disease accumulated by the system or organ (kidney, heart, liver, skin biopsy) clear AL amyloidosis, investigation and other secondary factors; (4) bone marrow or blood / urine fixed electrophoresis tips monoclonal plasmacytosis.

Exclusion criteria

Exclusion criteria: (1) biopsy for non AL amyloidosis; (2) plasma cells of multiple myeloma or other hematologic malignancies; (3) related diseases complicated with glaucoma, severe osteoporosis and peptic ulcer hemorrhage / history, mental disorders, Cushing syndrome and other hormone taboo; (4) combined infection, hepatitis, tuberculosis or other immunosuppressive taboo of the disease; (5) pregnant or lactating women; (6) there is a history of allergies or nearly 4 weeks of acute or chronic allergy to drugs used in clinical trials; (10) the life of less than expected 1 years; (11) the researchers estimate the compliance of patients is not suitable to participate in this study; (12) the past or present a history of cancer, the risk of tumor recurrence or metastasis.

Design outcomes

Primary

MeasureTime frame
complete remission;Organ response rate;

Secondary

MeasureTime frame
very good partial remission;partial remission;Survival Data Analysis;Overall survival rate;Progression free survival;

Countries

China

Contacts

Public ContactWang Wenjian

Guangdong General Hospital

wwjph@126.com+86 13928985527

Outcome results

None listed

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