Name | Type | Description | Interventions |
---|
1: Selinexor, Low-dose Dexamethasone and Pomalidomide (SPd) | Experimental | Each cycle is of 28 days
Cohort 1.1: Selinexor (SEL) 60/80/100 mg orally (PO) once weekly (QW); Dexamethasone (DEX) 40 mg PO once weekly; Pomalidomide (POM) 2/3/4 mg PO Days 1-21.
Cohort 1.2: SEL 40/60/80 mg PO twice weekly (BIW); DEX 20 mg PO twice weekly; POM 3/4 mg PO Days 1-21.
Cohort 1.3: Selinexor, Dexamethasone and Pomalidomide will be dosed at RP2D-1.
Cohort 1.4: SEL 40 mg PO QW; DEX 40 mg PO QW; POM 4mg PO once daily (QD) Days 1-21. | - Selinexor
- Dexamethasone
- Pomalidomide
|
2: Selinexor, Low-dose Dexamethasone and Bortezomib (SVd) | Experimental | Each cycle is of 35 days
Cohort 2.1: SEL 60/80/100 mg PO once weekly; DEX 40 mg PO once weekly; Bortezomib (BOR) 1.3 milligram per meter square (mg/m^2) subcutaneous (SC) once weekly.
Cohort 2.2: SEL 40/60/80 mg PO twice weekly; DEX 20 mg PO twice weekly; BOR 1.3 mg/m^2 subcutaneous (SC) once weekly.
Cohort 2.3: Selinexor, Dexamethasone and Bortezomib will be dosed at RP2D-2. | - Selinexor
- Dexamethasone
- Bortezomib
|
3: Selinexor, Low-dose DEX, and Lenalidomide (SRd) in RRMM | Experimental | Each cycle is of 28 days
Cohort 3.1: SEL 40/60/80/100 mg PO once weekly; DEX 40 mg PO once weekly; Lenalidomide (LEN) 15/25 mg PO Days 1-21.
Cohort 3.2: SEL 40/60/80 mg PO twice weekly; DEX 20 mg PO twice weekly; LEN 15/25 mg PO Days 1-21.
Cohort 3.3: Selinexor, Dexamethasone and Lenalidomide will be dosed at RP2D-3. | - Selinexor
- Dexamethasone
- Lenalidomide
|
4:Selinexor, Low-dose dexamethasone, Pomalidomide, Velcade (SPVd) | Experimental | PK Run-in Period: Selinexor and Clarithromycin:
For the first 9 patients enrolled into this dose escalation arm
14 day run-in period after which patients will proceed to Dose-Escalation Phase C1D1
Selinexor 40 mg will be dosed on Days 1 and 8. Clarithromycin 500 mg will be dosed twice daily on Days 2-8.
PK samples will be collected on Days 1 and 8 at 1, 1.5, 2, 3, 4, 5, 6, 8, and 24 hours post dose.
Dose-escalation Phase:
All patients enrolled into this Arm
Each cycle is of 28 days.
Cohort 4.1:
SEL 40/60 mg PO once weekly; DEX 40 mg PO once weekly; POM 4 mg PO Days 1-21; BOR 1.3 mg/m^2 subcutaneous (SC) once weekly.
Cohort 4.3: Selinexor, Dexamethasone, Pomalidomide, Velcade (Bortezomib) will be dosed at RP2D-4. | - Selinexor
- Dexamethasone
- Pomalidomide
- Bortezomib
- Clarithromycin
|
5: Selinexor, Low-dose dexamethasone, and Daratumumab (SDd) | Experimental | Each cycle is of 28 days
Cohort 5.1:
SEL 80/100 mg PO once weekly; DEX 40 mg once weekly (IV or PO); DARA: 16 mg/kg IV infusion Cycle 1-2: Once weekly, Cycle 3-6: Every other week, Cycle 6 and greater: Once a month.
Cohort 5.2:
SEL: 60 mg PO twice weekly; DEX: 40 mg weekly (IV or PO); DARA: 16 milligram per kilogram (mg/kg) IV infusion Cycle 1-2: Once. weekly, Cycle 3-6: Every other week, Cycle 6 and greater: Once a month.
Cohort 5.3: Selinexor, Dexamethasone and Daratumumab will be dosed at RP2D-5. | - Selinexor
- Dexamethasone
- Daratumumab
|
6: Selinexor, Low-dose dexamethasone, and Carfilzomib (SKd) | Experimental | PK Run-in Period: Selinexor and Clarithromycin:
For the first 9 patients enrolled into this dose escalation arm
14 day run-in period after which patient will proceed to Dose-Escalation Phase C1D1
Selinexor 40 mg will be dosed on Days 1 and 8. Clarithromycin 500 mg will be dosed twice daily on Days 2-8.
PK samples will be collected on Days 1 and 8 at 1, 1.5, 2, 3, 4, 5, 6, 8, and 24 hours post dose.
Dose-Escalation Phase:
All patients enrolled into this Arm
Each cycle is of 28 days
Cohort 6.1:
SEL 40/60/80/100 mg PO once weekly on days 1, 8, 15, and 22; DEX 40 mg IV or PO once weekly; Carfilzomib (CAR) 56 or 70 mg/m^2 IV infusion once weekly on days 1, 8, and 15.
Cohort 6.2:
SEL 60/80/100 mg PO once weekly on days 1, 8, and 15; DEX 40 mg IV or PO once weekly; CAR 56 or 70 mg/m^2 IV infusion once weekly on days 1, 8, and 15.
Cohort 6.3: Selinexor, Dexamethasone and Carfilzomib will be dosed at RP2D-6. | - Selinexor
- Dexamethasone
- Carfilzomib
- Clarithromycin
|
7: Selinexor, Low-dose DEX and Lenalidomide (SRd) in NDMM | Experimental | Each cycle is of 28 days
Cohort 7.1:
SEL 40/60/80 mg PO once weekly; DEX 40 mg PO once weekly; LEN 25 mg PO Days 1-21.
Cohort 7.3: Selinexor, Dexamethasone and Lenalidomide will be dosed at RP2D-7. | - Selinexor
- Dexamethasone
- Lenalidomide
|
8: Selinexor, Low-dose dexamethasone, and Ixazomib (SNd) | Experimental | PK Run-in Period: Selinexor & Clarithromycin:
For the first 9 patients enrolled into this dose escalation arm
14 day run-in period after which patient will proceed to Dose-Escalation Phase C1D1
Selinexor 40 mg will be dosed on Days 1 and 8. Clarithromycin 500 mg will be dosed twice daily on Days 2-8.
PK samples will be collected on Days 1 and 8 at 1, 1.5, 2, 3, 4, 5, 6, 8, and 24 hours post dose.
Dose-Escalation Phase:
All patients enrolled into this Arm
Each cycle is of 28 days
Cohort 8.1:
SEL 40/60/80/100 mg PO once weekly; DEX 20 mg PO twice weekly; IXA 3/4 mg PO once weekly.
Cohort 8.3: Selinexor, Dexamethasone and Ixazomib will be dosed at RP2D-8. | - Selinexor
- Dexamethasone
- Ixazomib
- Clarithromycin
|
9: Selinexor, Low-dose DEX, Pomalidomide and Elotuzumab (SPEd) | Experimental | PK Run-in Period: Selinexor and Clarithromycin:
For the first 9 patients enrolled into this dose escalation arm
14 day run-in period after which patient will proceed to Dose-Escalation Phase C1D1
Selinexor 40 mg will be dosed on Days 1 and 8. Clarithromycin 500 mg will be dosed twice daily on Days 2-8.
PK samples will be collected on Days 1 and 8 at 1, 1.5, 2, 3, 4, 5, 6, 8, and 24 hours post dose.
Dose-Escalation Phase:
All patients enrolled into this Arm
Each cycle is of 28 days
Cohort 9.1:
SEL 20/40/60 mg PO once weekly; DEX 28/20 mg PO twice weekly; POM 4 mg PO QD Days 1-21; Elotuzumab (ELO) 10/20 mg/kg IV will be given once weekly on Days 1,8, 15 and 22 of Cycles 1-2. Starting on Cycle 3 and continuing for future cycles, elotuzumab will be dosed at 20 mg/kg on Day 1 of each cycle only.
Cohort 9.3: Selinexor, Dexamethasone, Pomalidomide and Elotuzumab will be dosed at RP2D-9. | - Selinexor
- Dexamethasone
- Pomalidomide
- Elotuzumab
|
10. Selinexor, Dexamethasone, and Belantamab Mafodotin (SBd) | Experimental | Each cycle is of 21 days
Cohort 10.1:
SEL 40/60/80 mg PO once weekly on Days 1, 8, and 15; DEX 40 mg PO QW on Days 1, 8, and 15; Belantamab Mafodotin (BEL) 2.5 mg/kg IV infusion every 3 weeks (Q3W) Day 1 of each cycle.
Cohort 10.3:
Selinexor, Dexamethasone, and Belantamab Mafodotin will be dosed at RP2D-10. | - Selinexor
- Dexamethasone
- Belantamab Mafodotin
|
11. Selinexor, Dexamethasone, Pomalidomide, and Daratumumab (SDPd) | Experimental | Each Cycle is of 28 days
Cohort 11.1 SEL 40/60 mg PO once weekly on Days 1, 8, and 15; DEX total 40 mg weekly (IV or PO) single or divided doses on Days 1, 8, 15, and 22; POM 4 mg PO QW Days 1-21; DARA 16 mg/kg IV or SC QW on Days 1, 8, 15 and 22 of Cycles 1-2 and on Days 1 and 15 of Cycles 3-6, Day 1 of every Cycle greater than (>6).
Cohort 11.3 Selinexor, Dexamethasone, Pomalidomide, and Daratumumab will be dosed at RP2D-11. | - Selinexor
- Dexamethasone
- Pomalidomide
- Daratumumab
|