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An observational study of modified BRD Lite for newly diagnosed multiple myeloma patients not suitable for transplantation

An observational study of modified BRD Lite for newly diagnosed multiple myeloma patients not suitable for transplantation

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100043029
Enrollment
Unknown
Registered
2021-02-04
Start date
2021-03-01
Completion date
Unknown
Last updated
2021-05-24

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

Conditions

Multiple myeloma

Interventions

single arm:BRD-lite

Sponsors

The First Affiliated Hospital of Kunming Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Patients with symptomatic myeloma, organ damage related to myeloma; 2. Patients with myeloma can be measured by monoclonal antibody components in serum or urine or free light chain in serum; 3. Those patients who can promise to completely terminate sexual contact with the opposite sex, or start birth control.

Exclusion criteria

Exclusion criteria: 1. The patients who are qualified for autologous stem cell transplantation should be evaluated by comprehensive consideration of physical condition, concurrent diseases and other factors; 2. HIV positive patients with antiretroviral therapy; 3. Pregnant or lactating subjects; 4. Patients who have received any systemic anti myeloma therapy before; 5. Patients with primary amyloidosis or myeloma complicated with amyloidosis; 6. Patients who received other regimens within 14 days or during the period of enrollment; 7. Patients with known brain metastases; 8. Subjects with poor tolerance or known allergy to any of the research drugs or similar compounds; 9. Subjects with history of other malignant diseases except basal cell carcinoma or stage I cervical carcinoma; 10. Subjects who could not comply with the antithrombotic treatment protocol; 11. Subjects with peripheral neuropathy >= grade 2.

Design outcomes

Primary

MeasureTime frame
objective response rate;

Countries

China

Contacts

Public ContactMingxia Shi

The First Affiliated Hospital of Kunming Medical University

13888060581@163.com+86 13888060581

Outcome results

None listed

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