Bendamustine Hydrochloride, Bortezomib, and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma

• Status: Completed
• Trial end date: 2018-11-17
• Target enrollment: 0
• Participant gender: All

Summary

This phase II trial studies side effects and how well bendamustine hydrochloride, bortezomib, and dexamethasone work in treating patients with newly diagnosed multiple myeloma. Drugs used in chemotherapy, such as bendamustine hydrochloride and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving bendamustine hydrochloride with bortezomib and dexamethasone may kill more cancer cells.

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

Details

• Lead Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University
• Treatments: BB 1101; Bendamustine Hydrochloride; Bortezomib; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

Inclusion Criteria:

1. New diagnosis of multiple myeloma with no prior history of systemic treatment (Exceptions include corticosteroids, bisphosphonates, single agent cyclophosphamide, <= 21 days of the first cycle of a planned regimen

2. >= 18 years of age

3. ECOG <= 3

4. Signed informed consent

5. Measurable serum paraprotein on SPEP or serum free light chains and ratio, or quantifiable Bence-Jones proteinuria on 24 hour urine specimen. If the monoclonal protein has merged with the beta region we will follow the serum immunoglobulin of the involved heavy chain and comment on either partial remission (PR, as judged by two protocol investigators) or complete remission (CR, as defined by the achievement of PR as above and the resolution of the monoclonal protein by immunofixation in the serum and urine.)

Exclusion Criteria:

1. Failure to sign informed consent

2. Smoldering myeloma, monoclonal gammopathy of undetermined significance (MGUS), or plasma cell leukemia

3. History of previously treated smoldering myeloma

4. Grade 3 or above peripheral neuropathy

5. Uncontrolled human immunodeficiency virus (HIV)

6. Active hepatitis A, B or C

7. Pregnant or lactating females

8. Total bilirubin >3 times the upper limit of normal

9. ASLT/ALT > 2.5 times the upper limit of normal