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Modified IRD (IRD-lite) in Transplant Non-Eligible Patients With Newly Diagnosed Multiple Myeloma

Modified IRD (IRD-lite) in Transplant Non-Eligible Patients With Newly Diagnosed Multiple Myeloma

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900026348
Enrollment
Unknown
Registered
2019-10-01
Start date
2019-10-01
Completion date
Unknown
Last updated
2019-10-07

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

Conditions

multiple myeloma

Interventions

Sponsors

The First Affiliated Hospital, Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged at least 18 years. 2. Newly diagnosed as having MM according to the updated IMWG diagnostic criteria 2014 requiring treatment. 3. Not eligible for stem cell transplantation. 4. EGCO 0-3. 5. Estimated survival times over 6 months. 6. No receive any anti-tumor therapy (single use of glucocorticoid excluded). 7. Meet all of the following blood criteria within 14 days before therapy: a. Total bilirubin <= 3 x upper limit of normal (ULN). b. Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) <= 3 x ULN. 8. Meet the pregnancy prevention requirements: not of childbearing potential or agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug. 9. Able to provide written informed consent.

Exclusion criteria

Exclusion criteria: 1. Received other clinical trials for multiple myeloma within three months. 2. Received previous treatment for MM (single use of glucocorticoid excluded). 3. Prior or concurrent invasive malignancies. 4. Active systemic infection or any other medical or psychiatric condition which, in the opinion of the investigator, contraindicates the participant's participation in this study.

Design outcomes

Primary

MeasureTime frame
PFS;

Secondary

MeasureTime frame
response rate;toxicity;

Countries

China

Contacts

Public ContactJuan Li

The First Affiliated Hospital, Sun Yat-Sen University

13719209240@163.com+86 13719209240

Outcome results

None listed

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