Bendamustine Hydrochloride, Bortezomib, and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Blood Cancer, Blood Cancer, Blood Cancer, Hematology, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/8/2018 |
| Start Date: | August 25, 2014 |
| End Date: | January 2020 |
Phase II Study of Bendamustine, Bortezomib, and Dexamethasone (BBD) for Newly Diagnosed Patients With Multiple Myeloma
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.
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.
PRIMARY OBJECTIVES:
I. Establish the response rate of induction therapy following 4 cycles of the combination
regimen bendamustine (bendamustine hydrochloride), bortezomib and dexamethasone (BBd) in
patients with newly diagnosed multiple myeloma.
II. Describe the tolerability and toxicities of this regimen. III. Provide one-year
progression-free survival and one-year overall survival data following this therapeutic
strategy.
OUTLINE:
Patients receive bendamustine hydrochloride intravenously (IV) over 30 minutes on days 1 and
2; bortezomib subcutaneously (SC) on days 1, 8, 15, and 22; and dexamethasone orally (PO) on
days 1, 8, 15, and 22. Treatment repeats every 35 days for 4 courses in the absence of
disease progression or unacceptable toxicity. Patients achieving less than a very good
partial response (VGPR) or with more than 10% bone marrow plasmacytosis may receive 2
additional courses.
NOTE: Patients requiring immediate reduction in paraprotein during course 1 only receive
bendamustine hydrochloride IV over 30 minutes on days 1 and 2; bortezomib IV on days 1, 4, 8,
and 11; and dexamethasone PO on days 1-4.
After completion of study treatment, patients are followed up for 1 year.
I. Establish the response rate of induction therapy following 4 cycles of the combination
regimen bendamustine (bendamustine hydrochloride), bortezomib and dexamethasone (BBd) in
patients with newly diagnosed multiple myeloma.
II. Describe the tolerability and toxicities of this regimen. III. Provide one-year
progression-free survival and one-year overall survival data following this therapeutic
strategy.
OUTLINE:
Patients receive bendamustine hydrochloride intravenously (IV) over 30 minutes on days 1 and
2; bortezomib subcutaneously (SC) on days 1, 8, 15, and 22; and dexamethasone orally (PO) on
days 1, 8, 15, and 22. Treatment repeats every 35 days for 4 courses in the absence of
disease progression or unacceptable toxicity. Patients achieving less than a very good
partial response (VGPR) or with more than 10% bone marrow plasmacytosis may receive 2
additional courses.
NOTE: Patients requiring immediate reduction in paraprotein during course 1 only receive
bendamustine hydrochloride IV over 30 minutes on days 1 and 2; bortezomib IV on days 1, 4, 8,
and 11; and dexamethasone PO on days 1-4.
After completion of study treatment, patients are followed up for 1 year.
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
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