S0833, Modified Total Therapy 3 (TT3) for Newly Diagnosed Patients With Multiple Myeloma (MM): A Phase II SWOG Trial for Patients Aged ≤ 65 Years
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 21
- 主要终点
- Progression-free survival at 3 years
研究概览
简要总结
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Biological therapies, such as thalidomide and lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, cisplatin, doxorubicin hydrochloride, cyclophosphamide, etoposide, and melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Combining chemotherapy with autologous stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Giving bortezomib, thalidomide, and combination chemotherapy before and after transplant and lenalidomide after transplant may be an effective treatment for multiple myeloma.
PURPOSE: This phase II trial is studying how well giving bortezomib, thalidomide, and lenalidomide together with combination chemotherapy and autologous stem cell transplant works in treating patients with newly diagnosed multiple myeloma.
详细描述
OBJECTIVES:
Primary
- To assess progression-free survival (PFS) at 3 years in patients with newly diagnosed multiple myeloma (MM) treated with modified Total Therapy 3 (TT3).
Secondary
- To estimate the frequency and severity of toxicities associated with this treatment strategy in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
treatment
Ind (1cycle):
bort 1mg/m2 IV/SQ D1,4,8,11 D1-4: thalid 200mg/d & dex 20mg/d PO; cisplatin & dox 10mg/m2/d, cyclophos 400mg/m2/d, etoposide 40mg/m2/d contIV; enoxaparin 40mg/d SQ prn.
PBSC Coll: at recovery per local standard
Bridging (before/between trans/after Cons):
thal 50mg/d D1-21 & dex 20mg D1,8,15 PO
Tandem Trans (x2):
bort 1mg/m2 IV/SQ D-4,-1 D-4to-1: mel 50 mg/m2 IV, thal 200mg/d & dex 40mg/d PO PBSC >/=200x10^6 cells
Cons (1cycle):
same as Ind except cis/dox 7.5mg/m2/d, cyclo 300mg/m2/d, no enox
Maint(</= 3 yrs):
D1,8,15,22:bort 1mg/m2 IV/SQ, dex 20mg/d PO; len 20mg/d PO D1-20
干预措施: bortezomib (Drug)
treatment
Ind (1cycle):
bort 1mg/m2 IV/SQ D1,4,8,11 D1-4: thalid 200mg/d & dex 20mg/d PO; cisplatin & dox 10mg/m2/d, cyclophos 400mg/m2/d, etoposide 40mg/m2/d contIV; enoxaparin 40mg/d SQ prn.
PBSC Coll: at recovery per local standard
Bridging (before/between trans/after Cons):
thal 50mg/d D1-21 & dex 20mg D1,8,15 PO
Tandem Trans (x2):
bort 1mg/m2 IV/SQ D-4,-1 D-4to-1: mel 50 mg/m2 IV, thal 200mg/d & dex 40mg/d PO PBSC >/=200x10^6 cells
Cons (1cycle):
same as Ind except cis/dox 7.5mg/m2/d, cyclo 300mg/m2/d, no enox
Maint(</= 3 yrs):
D1,8,15,22:bort 1mg/m2 IV/SQ, dex 20mg/d PO; len 20mg/d PO D1-20
干预措施: cisplatin (Drug)
treatment
Ind (1cycle):
bort 1mg/m2 IV/SQ D1,4,8,11 D1-4: thalid 200mg/d & dex 20mg/d PO; cisplatin & dox 10mg/m2/d, cyclophos 400mg/m2/d, etoposide 40mg/m2/d contIV; enoxaparin 40mg/d SQ prn.
PBSC Coll: at recovery per local standard
Bridging (before/between trans/after Cons):
thal 50mg/d D1-21 & dex 20mg D1,8,15 PO
Tandem Trans (x2):
bort 1mg/m2 IV/SQ D-4,-1 D-4to-1: mel 50 mg/m2 IV, thal 200mg/d & dex 40mg/d PO PBSC >/=200x10^6 cells
Cons (1cycle):
same as Ind except cis/dox 7.5mg/m2/d, cyclo 300mg/m2/d, no enox
Maint(</= 3 yrs):
D1,8,15,22:bort 1mg/m2 IV/SQ, dex 20mg/d PO; len 20mg/d PO D1-20
干预措施: cyclophosphamide (Drug)
treatment
Ind (1cycle):
bort 1mg/m2 IV/SQ D1,4,8,11 D1-4: thalid 200mg/d & dex 20mg/d PO; cisplatin & dox 10mg/m2/d, cyclophos 400mg/m2/d, etoposide 40mg/m2/d contIV; enoxaparin 40mg/d SQ prn.
PBSC Coll: at recovery per local standard
Bridging (before/between trans/after Cons):
thal 50mg/d D1-21 & dex 20mg D1,8,15 PO
Tandem Trans (x2):
bort 1mg/m2 IV/SQ D-4,-1 D-4to-1: mel 50 mg/m2 IV, thal 200mg/d & dex 40mg/d PO PBSC >/=200x10^6 cells
Cons (1cycle):
same as Ind except cis/dox 7.5mg/m2/d, cyclo 300mg/m2/d, no enox
Maint(</= 3 yrs):
D1,8,15,22:bort 1mg/m2 IV/SQ, dex 20mg/d PO; len 20mg/d PO D1-20
干预措施: dexamethasone (Drug)
treatment
Ind (1cycle):
bort 1mg/m2 IV/SQ D1,4,8,11 D1-4: thalid 200mg/d & dex 20mg/d PO; cisplatin & dox 10mg/m2/d, cyclophos 400mg/m2/d, etoposide 40mg/m2/d contIV; enoxaparin 40mg/d SQ prn.
PBSC Coll: at recovery per local standard
Bridging (before/between trans/after Cons):
thal 50mg/d D1-21 & dex 20mg D1,8,15 PO
Tandem Trans (x2):
bort 1mg/m2 IV/SQ D-4,-1 D-4to-1: mel 50 mg/m2 IV, thal 200mg/d & dex 40mg/d PO PBSC >/=200x10^6 cells
Cons (1cycle):
same as Ind except cis/dox 7.5mg/m2/d, cyclo 300mg/m2/d, no enox
Maint(</= 3 yrs):
D1,8,15,22:bort 1mg/m2 IV/SQ, dex 20mg/d PO; len 20mg/d PO D1-20
干预措施: doxorubicin hydrochloride (Drug)
treatment
Ind (1cycle):
bort 1mg/m2 IV/SQ D1,4,8,11 D1-4: thalid 200mg/d & dex 20mg/d PO; cisplatin & dox 10mg/m2/d, cyclophos 400mg/m2/d, etoposide 40mg/m2/d contIV; enoxaparin 40mg/d SQ prn.
PBSC Coll: at recovery per local standard
Bridging (before/between trans/after Cons):
thal 50mg/d D1-21 & dex 20mg D1,8,15 PO
Tandem Trans (x2):
bort 1mg/m2 IV/SQ D-4,-1 D-4to-1: mel 50 mg/m2 IV, thal 200mg/d & dex 40mg/d PO PBSC >/=200x10^6 cells
Cons (1cycle):
same as Ind except cis/dox 7.5mg/m2/d, cyclo 300mg/m2/d, no enox
Maint(</= 3 yrs):
D1,8,15,22:bort 1mg/m2 IV/SQ, dex 20mg/d PO; len 20mg/d PO D1-20
干预措施: etoposide (Drug)
treatment
Ind (1cycle):
bort 1mg/m2 IV/SQ D1,4,8,11 D1-4: thalid 200mg/d & dex 20mg/d PO; cisplatin & dox 10mg/m2/d, cyclophos 400mg/m2/d, etoposide 40mg/m2/d contIV; enoxaparin 40mg/d SQ prn.
PBSC Coll: at recovery per local standard
Bridging (before/between trans/after Cons):
thal 50mg/d D1-21 & dex 20mg D1,8,15 PO
Tandem Trans (x2):
bort 1mg/m2 IV/SQ D-4,-1 D-4to-1: mel 50 mg/m2 IV, thal 200mg/d & dex 40mg/d PO PBSC >/=200x10^6 cells
Cons (1cycle):
same as Ind except cis/dox 7.5mg/m2/d, cyclo 300mg/m2/d, no enox
Maint(</= 3 yrs):
D1,8,15,22:bort 1mg/m2 IV/SQ, dex 20mg/d PO; len 20mg/d PO D1-20
干预措施: lenalidomide (Drug)
treatment
Ind (1cycle):
bort 1mg/m2 IV/SQ D1,4,8,11 D1-4: thalid 200mg/d & dex 20mg/d PO; cisplatin & dox 10mg/m2/d, cyclophos 400mg/m2/d, etoposide 40mg/m2/d contIV; enoxaparin 40mg/d SQ prn.
PBSC Coll: at recovery per local standard
Bridging (before/between trans/after Cons):
thal 50mg/d D1-21 & dex 20mg D1,8,15 PO
Tandem Trans (x2):
bort 1mg/m2 IV/SQ D-4,-1 D-4to-1: mel 50 mg/m2 IV, thal 200mg/d & dex 40mg/d PO PBSC >/=200x10^6 cells
Cons (1cycle):
same as Ind except cis/dox 7.5mg/m2/d, cyclo 300mg/m2/d, no enox
Maint(</= 3 yrs):
D1,8,15,22:bort 1mg/m2 IV/SQ, dex 20mg/d PO; len 20mg/d PO D1-20
干预措施: melphalan (Drug)
treatment
Ind (1cycle):
bort 1mg/m2 IV/SQ D1,4,8,11 D1-4: thalid 200mg/d & dex 20mg/d PO; cisplatin & dox 10mg/m2/d, cyclophos 400mg/m2/d, etoposide 40mg/m2/d contIV; enoxaparin 40mg/d SQ prn.
PBSC Coll: at recovery per local standard
Bridging (before/between trans/after Cons):
thal 50mg/d D1-21 & dex 20mg D1,8,15 PO
Tandem Trans (x2):
bort 1mg/m2 IV/SQ D-4,-1 D-4to-1: mel 50 mg/m2 IV, thal 200mg/d & dex 40mg/d PO PBSC >/=200x10^6 cells
Cons (1cycle):
same as Ind except cis/dox 7.5mg/m2/d, cyclo 300mg/m2/d, no enox
Maint(</= 3 yrs):
D1,8,15,22:bort 1mg/m2 IV/SQ, dex 20mg/d PO; len 20mg/d PO D1-20
干预措施: thalidomide (Drug)
treatment
Ind (1cycle):
bort 1mg/m2 IV/SQ D1,4,8,11 D1-4: thalid 200mg/d & dex 20mg/d PO; cisplatin & dox 10mg/m2/d, cyclophos 400mg/m2/d, etoposide 40mg/m2/d contIV; enoxaparin 40mg/d SQ prn.
PBSC Coll: at recovery per local standard
Bridging (before/between trans/after Cons):
thal 50mg/d D1-21 & dex 20mg D1,8,15 PO
Tandem Trans (x2):
bort 1mg/m2 IV/SQ D-4,-1 D-4to-1: mel 50 mg/m2 IV, thal 200mg/d & dex 40mg/d PO PBSC >/=200x10^6 cells
Cons (1cycle):
same as Ind except cis/dox 7.5mg/m2/d, cyclo 300mg/m2/d, no enox
Maint(</= 3 yrs):
D1,8,15,22:bort 1mg/m2 IV/SQ, dex 20mg/d PO; len 20mg/d PO D1-20
干预措施: gene expression analysis (Genetic)
treatment
Ind (1cycle):
bort 1mg/m2 IV/SQ D1,4,8,11 D1-4: thalid 200mg/d & dex 20mg/d PO; cisplatin & dox 10mg/m2/d, cyclophos 400mg/m2/d, etoposide 40mg/m2/d contIV; enoxaparin 40mg/d SQ prn.
PBSC Coll: at recovery per local standard
Bridging (before/between trans/after Cons):
thal 50mg/d D1-21 & dex 20mg D1,8,15 PO
Tandem Trans (x2):
bort 1mg/m2 IV/SQ D-4,-1 D-4to-1: mel 50 mg/m2 IV, thal 200mg/d & dex 40mg/d PO PBSC >/=200x10^6 cells
Cons (1cycle):
same as Ind except cis/dox 7.5mg/m2/d, cyclo 300mg/m2/d, no enox
Maint(</= 3 yrs):
D1,8,15,22:bort 1mg/m2 IV/SQ, dex 20mg/d PO; len 20mg/d PO D1-20
干预措施: microarray analysis (Genetic)
treatment
Ind (1cycle):
bort 1mg/m2 IV/SQ D1,4,8,11 D1-4: thalid 200mg/d & dex 20mg/d PO; cisplatin & dox 10mg/m2/d, cyclophos 400mg/m2/d, etoposide 40mg/m2/d contIV; enoxaparin 40mg/d SQ prn.
PBSC Coll: at recovery per local standard
Bridging (before/between trans/after Cons):
thal 50mg/d D1-21 & dex 20mg D1,8,15 PO
Tandem Trans (x2):
bort 1mg/m2 IV/SQ D-4,-1 D-4to-1: mel 50 mg/m2 IV, thal 200mg/d & dex 40mg/d PO PBSC >/=200x10^6 cells
Cons (1cycle):
same as Ind except cis/dox 7.5mg/m2/d, cyclo 300mg/m2/d, no enox
Maint(</= 3 yrs):
D1,8,15,22:bort 1mg/m2 IV/SQ, dex 20mg/d PO; len 20mg/d PO D1-20
干预措施: laboratory biomarker analysis (Other)
treatment
Ind (1cycle):
bort 1mg/m2 IV/SQ D1,4,8,11 D1-4: thalid 200mg/d & dex 20mg/d PO; cisplatin & dox 10mg/m2/d, cyclophos 400mg/m2/d, etoposide 40mg/m2/d contIV; enoxaparin 40mg/d SQ prn.
PBSC Coll: at recovery per local standard
Bridging (before/between trans/after Cons):
thal 50mg/d D1-21 & dex 20mg D1,8,15 PO
Tandem Trans (x2):
bort 1mg/m2 IV/SQ D-4,-1 D-4to-1: mel 50 mg/m2 IV, thal 200mg/d & dex 40mg/d PO PBSC >/=200x10^6 cells
Cons (1cycle):
same as Ind except cis/dox 7.5mg/m2/d, cyclo 300mg/m2/d, no enox
Maint(</= 3 yrs):
D1,8,15,22:bort 1mg/m2 IV/SQ, dex 20mg/d PO; len 20mg/d PO D1-20
干预措施: autologous-autologous tandem hematopoietic stem cell transplantation (Procedure)
结局指标
主要结局
Progression-free survival at 3 years
时间窗: 3 years
次要结局
- Overall survival(3 years)
- Frequency and severity of toxicities(3 years)
- Gene expression profiling analysis of CD138+ purified plasma cells(3 years)