UARK 2012-02 Trial For High-Risk Myeloma Evaluating Accelerating and Sustaining Complete Remission

PHASE2TerminatedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

June 10, 2014

Primary Completion Date

February 19, 2019

Study Completion Date

February 19, 2019

Conditions
Multiple Myeloma
Interventions
DEVICE

myPRS

Genome expression profiling used to identify high-risk and low-risk multiple myeloma

DRUG

Induction 1 - MEL-10+CFZ-TD-PACE

"Melphalan (MEL) and Carfilzomib (CFZ) will be given into a central venous catheter. Thalidomide (T) is a capsule and Dexamethasone (D) is a pill; both will be taken by mouth. Cisplatin (P), Adriamycin (A), Cyclophosphamide (C) and Etoposide (E) are all given into the vein (IV) by a continuous infusion through a central catheter. After completion of the continuous chemotherapy, Granulocyte colony-stimulating factor (G-CSF), a shot just under the skin to help the bone marrow and blood counts recover more quickly after chemotherapy, will be given.~Regimen: CFZ 20 mg/m2 on days 1, 5, \& 6; MEL 10mg/m2 on day 3; T 200 mg/d, D 40 mg/d, P 10 mg/m2/d, A 10 mg/m2/d, C 400 mg/m2/d, and E 40 mg/m2/d on days 5-8; G-CSF 10 mcg/kg/day from day 11 through end of Peripheral Blood Stem Cell (PBSC) collection.~Optional Bridging with T 50 mg/d and D 20 mg on day 1-4 every 21 days until 1st transplant."

DRUG

First Transplant - MEL-80+CFZ-TD-PACE + PBSC (biologic)

"Melphalan (MEL) and Carfilzomib (CFZ) will be given into a central venous catheter. Thalidomide (T) is a capsule and Dexamethasone (D) is a pill; both will be taken by mouth. Cisplatin (P), Adriamycin (A), Cyclophosphamide (C) and Etoposide (E) are all given into the vein (IV) by a continuous infusion through a central catheter. After completion of the continuous chemotherapy, Granulocyte colony-stimulating factor (G-CSF), a shot just under the skin to help the bone marrow and blood counts recover more quickly after chemotherapy, will be given.~Regimen: CFZ 20 mg/m2 on days -5 \& -4; MEL 20 mg/m2/d, T 200 mg/d, D 40 mg/d, P 10 mg/m2/d, A 10 mg/m2/d, C 100 mg/m2/d, and E 80 mg/m2/d on days -5 \& -2; PBSC transplant on day 0.~Optional Bridging with T 50 mg/d and D 20 mg on day 1-4 every 21 days until inter-therapy."

DRUG

Inter-Therapy - MEL-20+CFZ-TD-PACE (75%)

"Melphalan (MEL) and Carfilzomib (CFZ) will be given into a central venous catheter. Thalidomide (T) is a capsule and Dexamethasone (D) is a pill; both will be taken by mouth. Cisplatin (P), Adriamycin (A), Cyclophosphamide (C) and Etoposide (E) are all given into the vein (IV) by a continuous infusion through a central catheter. After completion of the continuous chemotherapy, Granulocyte colony-stimulating factor (G-CSF), a shot just under the skin to help the bone marrow and blood counts recover more quickly after chemotherapy, will be given.~Regimen: CFZ 27 mg/m2 on days 1-2; MEL 5 mg/m2/d, T 200 mg/d, D 20 mg/d, P 7.5 mg/m2/d, A 7.5 mg/m2/d, C 75 mg/m2/d, and E 60 mg/m2/d on days 1-4.~Optional Bridging with T 50 mg/d and D 20 mg on day 1-4 every 21 days until 2nd transplant."

DRUG

Second Transplant - MEL-80+CFZ-TD-PACE + PBSC (biologic)

"Melphalan (MEL) and Carfilzomib (CFZ) will be given into a central venous catheter. Thalidomide (T) is a capsule and Dexamethasone (D) is a pill; both will be taken by mouth. Cisplatin (P), Adriamycin (A), Cyclophosphamide (C) and Etoposide (E) are all given into the vein (IV) by a continuous infusion through a central catheter. After completion of the continuous chemotherapy, Granulocyte colony-stimulating factor (G-CSF), a shot just under the skin to help the bone marrow and blood counts recover more quickly after chemotherapy, will be given.~Regimen: CFZ 20 mg/m2 on days -5 \& -4; MEL 20 mg/m2/d, T 200 mg/d, D 40 mg/d, P 10 mg/m2/d, A 10 mg/m2/d, C 100 mg/m2/d, and E 80 mg/m2/d on days -5 \& -2; PBSC transplant on day 0.~Optional Bridging with T 50mg/d and D 20 mg on day 1-4 every 21 days until consolidation."

DRUG

Consolidation - CFZ-TD-PACE

"Carfilzomib (CFZ) will be given into a central venous catheter. Thalidomide (T) is a capsule and dexamethasone (D) is a pill; both will be taken by mouth. Cisplatin (P), adriamycin (A), cyclophosphamide (C) and etoposide (E) are all given into the vein (IV) by a continuous infusion through a central catheter.~Regimen: CFZ 27 mg/m2 on days 1-2; T 200 mg/d, D 40 mg/d, P 7.5 mg/m2/d, A 7.5 mg/m2/d, C 300 mg/m2/d, and E 30 mg/m2/d on days 1-4."

DRUG

Maintenance - CFZ-R(T)-D

"Carfilzomib (CFZ) will be given into a central venous catheter. Thalidomide (T) and lenalidomide (R) are capsules and dexamethasone (D) is a pill; all will be taken by mouth.~Regimen: For Cycles 1-12 CFZ 27 mg/m2/wk and D 12 mg/wk on days 1, 8, 15, \& 22; lenalidomide (R) 15 mg/d on days 1-21. For Cycles 13-24 CFZ 27 mg/m2/wk and D 12 mg/wk on days 1, 8, 15, \& 22. T may be substituted for R at 100 mg/day at the treating physician's discretion."

Trial Locations (1)

72205

University of Arkansas for Medical Sciences, Little Rock

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Amgen

INDUSTRY

lead

University of Arkansas

OTHER