To explore the efficacy and safety of pomalidomide and bendamustine with dexamethasone in relapsed or refractory multiple myeloma
The trial has two parts: firstly, to explore the maximum tolerated dosage(MTD) of bendamustine in the combination of pomalidomide and dexamethasone in relapsed or refractory multiple myeloma; secondly, to find out efficacy and safety of pomalidomide and bendamustine with dexamethasone in relapsed or refractory multiple myeloma in an expanded cohort.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
56
Pomalidomide( Anyue®, Chia Tai TIANQING, China), 4mg, orally(PO), d1-21, 28d/cycle, 1cycle.
Bendamustine( Leweixin®, Chia Tai TIANQING, China), 60mg/m2/d, intravenously(IV), d1-2, 28d/cycle, 1 cycle.
Dexamethasone, 40mg, PO or IV, d1, 8, 15, 22, 28d/cycle, 1 cycle.
Sun Yat-sen University Cancer Center
Guangzhou, Please Select, China
Overall response rate
The number of patients achieving partial response (PR), very good partial response (VGPR), complete response (CR) or stringent complete response (sCR) after 8 cycles in phase II. sCR = CR as defined in Primary Outcome measure 2 plus normal free light chain ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence. CR- Negative immunofixation on serum and urine and disappearance of soft tissue plasmacytomas and \< 5% plasma cells in bone marrow. VGPR = Serum and urine M-protein detectable by immunofixation but not on electrophoresis or \> 90% reduction in serum M-protein plus urine M-protein level \< 100 mg/24 h. PR- \> 50% reduction of serum M-protein and urine M-protein by \>90% or to \< 200 mg/24 h In addition, if present at baseline, a \> 50% reduction in the size of soft tissue plasmacytomas is also required.
Time frame: At the end of Cycle 8 in Phase II (each cycle is 28 days)
Complete response(CR) and stringent complete response(sCR) rate
The CR and sCR rate after 8 cycles in phase II. CR- Negative immunofixation on serum and urine and disappearance of soft tissue plasmacytomas and \< 5% plasma cells in bone marrow. sCR = CR as defined in Primary Outcome measure 2 plus normal free light chain ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.
Time frame: At the end of Cycle 8 in Phase II (each cycle is 28 days)
Progression free survival(PFS)
The time relapsed for patients between initiation of study therapy and either disease progression or death
Time frame: Through study completion, up to 2 years
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Number of participants with treatment-related adverse events during the study period as assessed by CTCAE v4.0
Time frame: Through study completion, up to 2 years
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Pomalidomide( Anyue®, Chia Tai TIANQING, China), 4mg, orally(PO), d1-21, 28d/cycle, 1cycle.
Bendamustine( Leweixin®, Chia Tai TIANQING, China), 70mg/m2/d, intravenously(IV), d1-2, 28d/cycle, 1 cycle.
Dexamethasone, 40mg, PO or IV, d1, 8, 15, 22, 28d/cycle, 1 cycle.
Pomalidomide( Anyue®, Chia Tai TIANQING, China), 4mg, orally(PO), d1-21, 28d/cycle, 1cycle.
Bendamustine( Leweixin®, Chia Tai TIANQING, China), 70mg/m2/d, intravenously(IV), d1-2, 28d/cycle, 1 cycle.
Dexamethasone, 40mg, PO or IV, d1, 8, 15, 22, 28d/cycle, 1 cycle.
Pomalidomide( Anyue®, Chia Tai TIANQING, China), 4mg, orally(PO), d1-21, 28d/cycle, 8 cycles. Then pomalidomide( Anyue®, Chia Tai TIANQING, China), 4mg, orally(PO), d1-21, 28d/cycle until progression or intolerable toxicities.
Bendamustine( Leweixin®, Chia Tai TIANQING, China), 70mg/m2/d, intravenously(IV), d1-2, 28d/cycle, 8 cycles.
Dexamethasone, 40mg, PO or IV, d1, 8, 15, 22, 28d/cycle, 8 cycles. Then dexamethasone, 40mg, PO or IV, d1, 8, 15, 22, 28d/cycle until progression or intolerable toxicities.