Status:
UNKNOWN
Clinical Trial of Clarithromycin, Lenalidomide and Dexamethasone in the Treatment of the First Relapsed Multiple Myeloma
Lead Sponsor:
The First Hospital of Jilin University
Conditions:
Multiple Myeloma in Relapse
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
BiRd regimen consisting of clarithromycin and Rd is safe and effective in NDMM. It can significantly increase ORR (up to 90.3%) , relief depth (≥VGPR), and prolong PFS to 43 months. In our previous st...
Eligibility Criteria
Inclusion
- diagnosed as symptomatic multiple myeloma.
- the first relapse/progression with thalidomide, bortezomib or lenalidomide based current first-line treatment or resistance to the first-line treatment (previous treatment line number =1).
- there must be measurable lesions to determine disease progression (PD): according to the IMWG 2016 efficacy evaluation criteria.
- the expected survival time is longer than 3 months.
- ECOG score less than 2 points.
- the serum AST/ALT level \<3 times higher than the normal value; the serum total bilirubin level\<2 times of the normal value; creatinine clearance rate was ≥30ml/mi.
- neutrophil count \>1000/mm3 ; platelet count \>75000/mm3 (if bone marrow plasma cell \<50%) or \>30000/mm3 (if the plasma cells in the bone marrow is not less than 50%).
- women of childbearing age were negative for pregnancy before admission, and agreed to carry out pregnancy screening during the study (once a month until 4 weeks after the last dose), and agreed to use contraceptive measures within 3 months after the study and the last dose.
- all patients were required to sign informed consent.
Exclusion
- under the age of 18
- ECOG score \>2
- non secretory myeloma, defined as serum protein M \< 1g/dL, urinary M protein \< 200mg/24h and sFLCR ≤100mg/L
- there is growing demand, pregnant or lactating women within one year
- HIV infection
- activity of HBV or HCV infection
- 4 weeks before entering the group of thromboembolic events
- not signed informed consent
Key Trial Info
Start Date :
March 21 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2020
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04063189
Start Date
March 21 2017
End Date
February 1 2020
Last Update
August 21 2019
Active Locations (1)
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1
The First Hospital of Jilin University
Changchun, Jilin, China, 130021