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Clinical Observation for Short-term lenalidomide Maintenance Therapy for MM Patients with Negative NGF-MRD after ASCT

Clinical Observation for Short-term lenalidomide Maintenance Therapy for MM Patients with Negative NGF-MRD after ASCT

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000029293
Enrollment
Unknown
Registered
2020-01-21
Start date
2020-03-01
Completion date
Unknown
Last updated
2020-02-03

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

Conditions

multiple myeloma

Interventions

Case series:Nil

Sponsors

Department of Hematology, Myeloma Research Center of Beijing, Beijing Chao-Yang Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. under 65 years old; 2. No contraindication of transplantation; 3. Patients with measurable diseases defined as serum M protein (> 0.5 g/dL) or urine M protein (> 200 mg/24 hours) ,or without measurable serum or urine M protein but serum free light chain (sFLC) > 100 mg/L (involved light chain) and abnormal kappa/lambda ratio (SFLC kappa/lambda ratio 1.65).

Exclusion criteria

Exclusion criteria: 1. smodering multiple myeloma; 2. Previous treatment for myeloma; 3. Severe abnormalities in vital organs such as heart, lung and liver (lower than 50% ejection fraction of heart, 50% carbon monoxide diffusion ability caused by chronic respiratory diseases, more than 2 mg/dl serum bilirubin, or 2.5 times higher than the normal upper limit); 4. LSerum creatinine is higher than 300 umol/L; 5. plasma cell leukemia (PERIPHERAL PLASMA CELLS > 2.0 *109/L or > 20%); 6. Known amyloidosis; 7. Multiple myeloma of IgM subtype; 8. Those with mental disorders, cognitive impairment or other reasons who cannot control themselves; 9. Researchers do not think it is appropriate to join the group; 10. Patients with skeletal or extramedullary plasmacytoma.

Design outcomes

Primary

MeasureTime frame
PFS;

Secondary

MeasureTime frame
OS;MRD negative rate;Neuropathy events;Quality of Life;

Contacts

Public ContactGao Wen

Department of Hematology, Myeloma Research Center of Beijing, Beijing Chao-Yang Hospital, Capital Medical University

gaowenpingping@163.com+86 010-85231572

Outcome results

None listed

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