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Clinical study of boanmycin in the treatment of relapsed and refractory multiple myeloma

Clinical study of boanmycin in the treatment of relapsed and refractory multiple myeloma

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200056356
Enrollment
Unknown
Registered
2022-02-04
Start date
2022-02-01
Completion date
Unknown
Last updated
2024-09-23

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

Conditions

multiple myeloma

Interventions

A:Boanmycin combined with low-dose dexamethasone
B:Boanmycin combined with classic drugs (PI, iMIDs or cytotoxic drugs)

Sponsors

Longgang District People’s Hospital of Shenzhen
Lead Sponsor

Eligibility

Sex/Gender
All
Age
10 Years to 95 Years

Inclusion criteria

Inclusion criteria: 1. Patients who diagnosed with multiple myeloma according to the diagnostic criteria of the Chinese Guidelines for the Diagnosis and Treatment of Multiple Myeloma (Revised 2020) [Annex 1]; 2. Patients who have undergone more than 6 rounds of current treatment for multiple myeloma such as proteasome inhibitors and iMIDS, or at least 2 relapses after autologous hematopoietic stem cell transplantation, or patients who cannot tolerate treatment with proteasome inhibitors and iMIDS and cytotoxic drugs such as adriamycin and cyclophosphamide for at least one relapse; 3. At least one indicator of multiple myeloma that can be measured and assessed for efficacy: (1) serum M protein >= 0.5g/dL (5g/L); (2) urine M protein >= 200mg/24h; (3) serum free light chain assay: in the case of an abnormal serum free light chain ratio, the level of affected free light chain >= 10mg/dL (100mg/L); (4) the ratio of myeloma cell in tumor tissues greater than or equal to 10% or more, or extramedullary plasmacytoma may be measured.

Exclusion criteria

Exclusion criteria: 1.Patients with a history of allergy to boanmycin; 2.Patients with severe heart failure, respiratory failure, or hepatic failure; 3.Patients with bloodstream infection, infectious shock; 4.Unconscious patients; 5.Patients with central nervous system disorders requiring treatment; 6.Pregnant women; 7.Those who have participated in other clinical trials within one month.

Design outcomes

Primary

MeasureTime frame
Objective Response Rate;

Secondary

MeasureTime frame
Duration of Response;Progression-free Survival;Overall Survival;

Countries

China

Contacts

Public ContactTian Faqing

Longgang District People’s Hospital of Shenzhen

trumantfq@163.com+86 13809893405

Outcome results

None listed

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