Relapsed or Refractory Multiple Myeloma
Conditions
Interventions
Sponsors
The Second Clinical Medical College, Yangtze University, Jingzhou Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged between 18 and 80 with relapsed or refractory multiple myeloma. 2. Bone marrow sample is confirmed as BCMA-positive or CD38-positive by flow cytometry or pathological examination. 3. Patients with relapsed or refractory multiple myeloma who meet the following conditions: 1) Treatment failure or disease progressed after 2 courses of standard treatment regimen; 2) Disease relapsed after chemotherapy or HSCT. Curative efficacy is little or disease progressed after 2 courses of original treatment regimen; 3) More than 60 days between last treatment and disease progression; 4) Autologous or allogeneic SCT is not available at present, or patient refuses to receive SCT; 5) Disease progression is defined as Chinese Guidelines for Diagnosis and Treatment of Multiple Myeloma (Revision in 2015). At least one of the following conditions should be met: Serum M-protein increases >=25% (absolute increase should be >=5 g/L). If serum M protein is >=50 g/L at baseline, increase of serum M protein can be >=10 g/L; Urine M-protein increases >=25% (absolute increase should be >=200 mg/24 h); If the serum and urine M-protein are not detectable, a >=25% increase in the difference between involved and uninvolved FLC levels is required (absolute increase should be >=100 mg/L); Bone marrow plasma cell percentage increases >=25% (absolute increase should be >=10%); Size of existing bone lesions or soft tissue plasmacytomas increases by >=25%, or development of new lytic bone lesions or soft tissue plasmacytomas; Development of hypercalcemia that can be attributed to plasma cell proliferative disorder (corrected calcium is > 2.8 mmol/L or 11.5 mg/dL); Disease progression must be confirmed by 2 sequential assessments; 4. Expected survival > 12 weeks; 5. Disease is measurable, and at least one of the following conditions should be satisfied: 1) Serum M-protein is >=10 g/L; 2) 24-hour urine M-protein is >=200 mg; 3) Serum FLC is >=5 mg/dL; 4) Plasmacytomas that can be measured or evaluated by imaging; 5) Bone marrow plasma cell percentage is >=20%. 6. ECOG scores 0 - 1; 7. Adequate venous access for apheresis and venous blood sampling, and no other contraindications for leukapheresis; The above lab results should not include those obtained from continuous supportive treatment that is ongoing.
Exclusion criteria
Exclusion criteria: 1. Performed autologous or allogeneic stem cell transplantation within 3 months before enrollment; 2. Asymptomatic Myeloma (Smouldering Multiple Myeloma); 3. Previous BCMA or CD38 targeted cell therapy; 4. Previous chimeric antigen receptor therapy or other lentivirus-mediated transgenic therapy; 5. Presence of uncontrollable or anti-infective fungal, bacterial, viral or other infections; 6. Patients requiring systemic corticosteroid therapy (1. Patients aged between 18 and 80 with relapsed or refractory multiple myeloma. 2. Bone marrow sample is confirmed as BCMA-positive or CD38-positive by flow cytometry or pathological examination. 3. Patients with relapsed or refractory multiple myeloma who meet the following conditions: 1) Treatment failure or disease progressed after 2 courses of standard treatment regimen; 2) Disease relapsed after chemotherapy or HSCT. Curative efficacy is little or disease progressed after 2 courses of original treatment regimen; 3) More than 60 days between last treatment and disease progression; 4) Autologous or allogeneic SCT is not available at present, or patient refuses to receive SCT; 5) Disease progression is defined as Chinese Guidelines for Diagnosis and Treatment of Multiple Myeloma (Revision in 2015). At least one of the following conditions should be met: Serum M-protein increases >=25% (absolute increase should be >=5 g/L). If serum M protein is >=50 g/L at baseline, increase of serum M protein can be >=10 g/L; Urine M-protein increases >=25% (absolute increase should be >=200 mg/24 h); If the serum and urine M-protein are not detectable, a >=25% increase in the difference between involved and uninvolved FLC levels is required (absolute increase should be >=100 mg/L); Bone marrow plasma cell percentage increases >=25% (absolute increase should be >=10%); Size of existing bone lesions or soft tissue plasmacytomas increases by >=25%, or development of new lytic bone lesions or soft tissue plasmacytomas; Development of hypercalcemia that can be attributed to plasma cell proliferative disorder (corrected calcium is > 2.8 mmol/L or 11.5 mg/dL); Disease progression must be confirmed by 2 sequential assessments; 4. Expected survival > 12 weeks; 5. Disease is measurable, and at least one of the following conditions should be satisfied: 1) Serum M-protein is >=10 g/L; 2) 24-hour urine M-protein is >=200 mg; 3) Serum FLC is >=5 mg/dL; 4) Plasmacytomas that can be measured or evaluated by imaging; 5) Bone marrow plasma cell percentage is >=20%. 6. ECOG scores 0 - 1; 7. Adequate venous access for apheresis and venous blood sampling, and no other contraindications for leukapheresis; The above lab results should not include those obtained from continuous supportive treatment that is ongoing. 5mg/ d prednisone or equivalent dose of other corticosteroids) or other immunosuppressive drugs (except for adverse events) during the study period; 7. Any indwelling catheter or drainage tube (such as percutaneous nephrostomy, indwelling catheter, bile drainage tube or pleural/peritoneal/pericardial catheter) is present, allowing the use of a dedicated central venous catheter; 8. A history or disease of the central nervous system, such as seizure disease, cerebral ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease involving the central nervous system; 9. Presence of clinically significant cardiovascular disease, such as uncontrolled or symptomatic arrhythmias, congestiv
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Response Rate;Duration Of Response;Progression Free Survival;the effect in extramedullary infiltration;Adverse events; | — |
Countries
China
Contacts
Public ContactZhiping Huang
The Second Clinical Medical College, Yangtze University, Jingzhou Central Hospital
Outcome results
None listed