D: Decitabine(15mg/m2) d1-5 G: G-CSF（300ug/d） d0-9(stop using when WBC>20*109/L) T: rhTPO(15000U/d) d3,5,7,9, d11- (Platelet>50*109/L) A: Aclarubicin(10mg/d) d3-6 C: Cytarabine(15mg Q12h) d3-9

Acute Myeloid Leukemia

D: Decitabine(15mg/m2) d1-5 G: G-CSF（300ug/d） d0-9(stop using when White Blood Cell (WBC)>20*109/L) T: rhTPO(15000U/d) d3,5,7,9, d11- (Platelet>50*109/L) A: Aclarubicin(10mg/d) d3-6 C: Cytarabine(15mg Q12h) d3-9

rhTPO

ShengJing Hospital of China Medical University

D-CTAG in the Treatment of Newly Diagnosed Acute Myeloid Leukemia in Elderly Patients

Huihan Wang

Deputy Chief Physician

• Pemetrexed and cisplatin will be admixed together in 1 liter of normal saline. The admixture of pemetrexed/cisplatin is stable for 4 hours and should be prepared and delivered immediately before use in the OR. The length of the pemetrexed/cisplatin lavage will be 1 hour.

Mesothelioma

Pemetrexed

Cisplatin

Baylor St Lukes

Study of Cytoreductive Surgery and Hyperthermic Intraoperative Chemotherapy With Pemetrexed and Cisplatin for Malignant Pleural Mesotheliomas

Phase I Study of Cytoreductive Surgery and Hyperthermic Intraoperative Chemotherapy With Pemetrexed and Cisplatin for Malignant Pleural Mesotheliomas

Shawn Groth

Assistant Professor

Baylor College of Medicine

Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days
Bendamustine: once intravenous (IV) dosing on day 1, every 28 days
Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days

Pomalidomide 3mg: once daily oral (PO) dosing on days 1-21, every 28 days
Bendamustine 120 mg: once intravenous (IV) dosing on day 1, every 28 days
Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days

Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days
Bendamustine: once intravenous (IV) dosing on day 1, every 28 days
Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days
After 6 cycles of treatment, dexamethasone may be decreased to 20mg. After total 12 cycles of treatment, subjects will proceed to the maintenance phase until time of progression.
Study treatment will be administered starting at Cohort 1 for up to four sequential cohorts, with 3-6 patients in each cohort.

Cohort 1: 120mg Bendamustine + 3mg Pomalidomide

Cohort 2: 120mg Bendamustine + 4mg Pomalidomide

Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days
Bendamustine: once intravenous (IV) dosing on day 1, every 28 days
Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days
After 6 cycles of treatment, dexamethasone may be decreased to 20mg. After total 12 cycles of treatment, subjects will proceed to the maintenance phase until time of progression.
Study treatment will be administered at the Maximum Tolerated Dose.

Expansion: 120mg Bendamustine + 3mg Pomalidomide

Total

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Region of Enrollment

In the phase I dose escalation portion, patients will be sequentially enrolled in 4 cohorts at dose levels in a standard 3+3 design until the maximum tolerated dose (MTD) is reached.
Cohort 1 (bendamustine 120mg/m2 + pomalidomide 3mg); Cohort 2 (bendamustine 120mg/m2 + pomalidomide 4mg); Cohort 3 (bendamustine 150mg/m2 + pomalidomide 4mg); Cohort 4 (bendamustine 180mg/m2 + pomalidomide 4mg)
If dose limiting toxicity (DLT) is observed in 2 or more of the six patients at the same dosing level while DLT is observed in only 1 or none of the 6 patients at the dosing level immediately below it, then the lower dosing level will be defined as the maximum tolerated dose (MTD).

Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days
Bendamustine: once intravenous (IV) dosing on day 1, every 28 days
Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days
Study treatment will be administered starting at Cohort 1 for up to four sequential cohorts, with 3-6 patients in each cohort. (Dose escalation)
Bendamustine: Bendamustine 120mg/m2 (cohort 1, 2) or 150 mg/m2 (cohort 3), or 180mg/m2 (cohort 4) will be administered intravenously on day 1, every 28 days for 12 cycles.
Pomalidomide: Pomalidomide 3mg (cohort 1) or 4mg (cohort 2, 3, 4) will be administered once daily orally (PO) on days 1-21, every 28 days until disease progression or death.
Dexamethasone: Dexamethasone will be administered weekly orally or intravenously on days 1, 8,

Cohorts 1 and 2

Maximum Tolerated Dose of Pomalidomide and Bendamustine

The number of patients achieving a complete response (CR) or partial response (PR). Response is defined by the International Myeloma Working Group as:
CR- Negative immunofixation on serum and urine and disappearance of soft tissue plasmacytomas and < 5% plasma cells in bone marrow
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
VGPR - Serum and urine M-protein detectable by immunofixation but n

Initial Response Rate

The number of patients achieving stable disease (SD), partial response (PR), very good partial response (VGPR), complete response (CR) or stringent complete response (sCR)
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
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
SD = Not meeting criteria for CR, VGPR, PR, or progressive disease

Overall Response Rate

Time to progression - defined as time elapsed in patients between achievement of response and disease progression

Time to Progression

Time to next Therapy - defined as the time elapsed for patients from initiation of study therapy until initiation of next therapy

Time to Next Therapy

The time elapsed for patients between initiation of study therapy and either disease progression or death

Progression Free Survival

Overall Study

Cristina Gasparetto, MD

Multiple Myeloma

Bendamustine will be administered intravenously over 1 hour (if using Treanda) or over 10 minutes (if using Bendeka) on day 1, every 28 days for 12 cycles.

Bendamustine

Pomalidomide will be administered once daily orally (PO) on days 1-21, every 28 days until disease progression or death.

Pomalidomide

Dexamethasone will be administered weekly orally or intravenously on days 1, 8, 15, and 22 every 28 days until disease progression or death. After 6 cycles of treatment, the dose may be reduced to 20mg at investigator's discretion. For subjects ≥ 75 years of age, the starting dose of dexamethasone is 20 mg/day on Days 1, 8, 15 and 22 of each 28-day treatment cycle.

Dexamethasone

Duke University Medical Center

Bendamustine + Pomalidomide + Dex in R/R Multiple Myeloma

A Phase I-II Study of the Combination of Bendamustine and Pomalidomide With Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma

Cristina Gasparetto

Sponsor Investigator

Celgene

Dose escalation with 3+3 cohort design plus Dose expansion at the Maximum tolerated dose.

antidiarrheals/versterkte bloedingsneiging

D-CTAG in the Treatment of Newly Diagnosed Acute Myeloid Leukemia in Elderly Patients

Study of Cytoreductive Surgery and Hyperthermic Intraoperative Chemotherapy With Pemetrexed and Cisplatin for Malignant Pleural Mesotheliomas

Bendamustine + Pomalidomide + Dex in R/R Multiple Myeloma

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