NCT02224729 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2025-04-30

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Count of Participants That Experience Overall Response Following 4 Cycles of the Combination Regimen BBd

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outcome · POSTED

Incidence of Grade 3-4 Adverse Events From the Combination of Bendamustine Hydrochloride, Bortezomib, and Dexamethasone Based on the Common Terminology Criteria Version 4.0

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outcome · POSTED

Count of Participants That Experience Very Good Partial Remission (VGPR)

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outcome · POSTED

Count of Participants That Experience Progression-free Survival (PFS)

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outcome · POSTED

Count of Participants That Experience Overall Survival (OS)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility 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
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Patients receive bendamustine hydrochloride IV over 30 minutes on days 1 and 2; bortezomib SC on days 1, 8, 15, and 22; and dexamethasone 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 VGPR or with more than 10% bone marrow plasmacytosis may receive 2 additional courses.
intervention Names
Drug: Bendamustine hydrochloride
Drug: Bortezomib
Drug: Dexamethasone
label
Bendamustine, Bortezomib, Dexamethasone (Standard)
type
EXPERIMENTAL

interventions

arm Group Labels
Bendamustine, Bortezomib, Dexamethasone (Standard)
description
Given IV
name
Bendamustine hydrochloride
other Names
Treakisym
Ribomustin
Levact
Treanda
SDX-105
type
DRUG
arm Group Labels
Bendamustine, Bortezomib, Dexamethasone (Standard)
description
Given SC
name
Bortezomib
other Names
PS-341
Velcade
Cytomib
type
DRUG
arm Group Labels
Bendamustine, Bortezomib, Dexamethasone (Standard)
description
Given PO
name
Dexamethasone
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 24
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
ORR (partial remission or better) to induction therapy following 4 cycles of the combination regimen BBd.
measure
Count of Participants That Experience Overall Response Following 4 Cycles of the Combination Regimen BBd
time Frame
At least 140 days

secondary Outcomes

description
All adverse events are tracked during the course of the trial. Adverse events with a grade of 3-4 will be tracked and recorded.
measure
Incidence of Grade 3-4 Adverse Events From the Combination of Bendamustine Hydrochloride, Bortezomib, and Dexamethasone Based on the Common Terminology Criteria Version 4.0
time Frame
Up to 1 year
description
Very good partial remission (VGPR) to induction therapy following 4 cycles of the combination regimen BBd. As defined as no dectable M-protein on SPEP (Serum protein electrophoresis) but positive IFX (Immunofixation) on serum or urine and \>90% reduction of M-protein in serum and urine
measure
Count of Participants That Experience Very Good Partial Remission (VGPR)
time Frame
Up to 1 year
description
The amount of participants that survive one year after treatment with BBd and do not experience worsening disease.
measure
Count of Participants That Experience Progression-free Survival (PFS)
time Frame
1 year
description
The amount of participants that start treatment with BBd and survive at least one year post treatment completion.
measure
Count of Participants That Experience Overall Survival (OS)
time Frame
1 year

Full study description

brief 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.
detailed Description: 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.

Source references