Bendamustine + Pomalidomide + Dex in R/R Multiple Myeloma

• Status: Active, not recruiting
• Trial end date: 2023-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed as a phase I-II, open label, dose finding study.

Study treatment will be as follows, in 28 day cycles:

• Pomalidomide: once daily orally (PO) dosing on days 1-21, every 28 days

• Bendamustine: once intravenously (IV) dosing on day 1, every 28 days

• Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22.

After completing 6 cycles of treatment, dexamethasone may be decreased to 20mg per investigator discretion. After completing 12 cycles of treatment, patients will proceed to the maintenance phase of the study. Patients will receive Pomalidomide on day 1-21, every 28 days and dexamethasone on days 1, 8, 15, and 22 every 28 days until time of progression.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cristina Gasparetto
• Collaborator: Celgene
• Treatments: BB 1101; Bendamustine Hydrochloride; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Pomalidomide; Thalidomide

Criteria

INCLUSION CRITERIA:

Patients must meet all of the following inclusion criteria to be eligible to enroll in this study.

1. Cytopathologically or histologically confirmed diagnosis of multiple myeloma

2. Relapsed or refractory to most recent therapy (i.e. < 25% response, progression during therapy or within 60 days after completion).

3. Refractory to prior lenalidomide therapy (i.e. history of progression on therapy using full or maximally tolerated dose of lenalidomide for >/= two cycles).

4. Measurable disease:

• Serum M protein > 0.5 g/dL or

• Urine Bence Jones protein >200 mg/24 hr or

• Elevated Free Light Chain per International Myeloma Working Group (IMWG) criteria, and abnormal ratio

5. Evidence of progression/relapse

6. Over 18

7. Life expectancy of more than 3 months

8. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2

9. Total bilirubin < 2 times the upper limit of normal (ULN), and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 times ULN

10. Serum creatinine <3 mg/dL

11. • Absolute neutrophil count (ANC) >1.0 x 109/L or <1.0 x 109/L but > 0.75 due to >30%* marrow involvement (without granulocyte and granulocyte/macrophage colony stimulating factor (GCSF and GMCSF) for >1 week and of pegylated GCSF for >2 weeks)

• Hemoglobin >8 g/dL

• Platelet count >75.0 x 109/L or < 75.0 x 109/L but >50.0 x 109/L due to >30%* marrow involvement (without platelet transfusions for >1 week)

• Transfusions allowed if clinically indicated

12. Agree to take enteric coated aspirin 81 mg daily

13. Consent

14. Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test and abstain from sex or begin TWO acceptable methods of birth control >28 days before pomalidomide dose, and agree to ongoing pregnancy testing.

15. Male patients must abstain from sex or use a latex condom and not donate sperm while taking pomalidomide and for 1 week after stopping drug.

16. Register with POMALYST REMS™ and comply with their requirements.

EXCLUSION CRITERIA:

1. Patients with known sensitivity to immunomodulatory drugs (IMiDs)

2. Use of experimental drugs or therapy within 21 days of study-related drug therapy.

3. Exposure to chemotherapy or steroids within 14 days of study-related drug therapy.

4. Prior use of pomalidomide.

5. Radiation therapy within 14 days of screening.

6. POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).

7. Plasma cell leukemia.

8. Waldenström's macroglobulinemia.

9. Major surgery within 21 days prior to first dose.

10. Pregnant or lactating females.

11. Congestive heart failure, symptomatic ischemia, conduction abnormalities uncontrolled or myocardial infarction in the last six months.

12. Uncontrolled hypertension

13. Acute active infection requiring systemic antibiotics, antivirals, or antifungals within 14 days prior to first dose.

14. Active treatment or intervention for other malignancy or need active treatment within 8 months of starting study treatment.

15. Serious psychiatric or medical conditions that interfere with treatment

16. Significant neuropathy (Grade 3, Grade 4) at first dose and/or within 14 days before enrollment

17. Contraindication to required concomitant drugs

18. Patients with primary systemic amyloidosis