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Once-weekly 1.6mg/m2 bortezomib BCD regimen in elderly patients with newly diagnosed multiple myeloma who are ineligible for high-dose therapy

Once-weekly 1.6mg/m2 bortezomib BCD regimen in elderly patients with newly diagnosed multiple myeloma who are ineligible for high-dose therapy

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OPC-15006337
Enrollment
Unknown
Registered
2015-05-02
Start date
2010-03-01
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

elderly patients with newly diagnosed multiple myeloma who are ineligible for high-dose therapy:Once-weekly 1.6mg/m2 bortezomib BCD regimen

Sponsors

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 81 Years

Inclusion criteria

Inclusion criteria: elderly patients with newly diagnosed, symptomatic multiple myeloma and measurable disease who had not received prior therapy. 1. Age >=65 years and unsuitable for HDT with ASCT; 2. Eastern Cooperative Oncology Group performance status of 1000/uL, hemoglobin level >10g/dL and platelets >80000/uL.

Exclusion criteria

Exclusion criteria: 1. Significant pre-existing peripheral neuropathy (defined as >=grade 3); 2. Left ventricular ejection fraction <=0.50, or those who had symptoms of congestive heart failure; 3. Uncontrolled angina, or significant arrhythmias; 4. Recurrent deep vein thrombosis or pulmonary thromboembolism; 5. Chemotherapeutic drug allergy, for example, patients with hypersensitivity to bortezomib.

Design outcomes

Primary

MeasureTime frame
response rate;

Secondary

MeasureTime frame
overall surviva;progression-free survival;

Countries

China

Contacts

Public ContactZhu Qi
zhuqi70@hotmail.com+86 13764188348

Outcome results

None listed

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