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

Primary Purpose

Stage I Multiple Myeloma, Stage II Multiple Myeloma, Stage III Multiple Myeloma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bendamustine hydrochloride
Bortezomib
Dexamethasone
Sponsored by
Sidney Kimmel Cancer Center at Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stage I Multiple Myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Thomas Jefferson University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bendamustine, Bortezomib, Dexamethasone (Standard)

Arm 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.

Outcomes

Primary Outcome Measures

Count of Participants That Experience Overall Response Following 4 Cycles of the Combination Regimen BBd
ORR (partial remission or better) to induction therapy following 4 cycles of the combination regimen BBd.

Secondary Outcome Measures

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
All adverse events are tracked during the course of the trial. Adverse events with a grade of 3-4 will be tracked and recorded.
Count of Participants That Experience Very Good Partial Remission (VGPR)
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
Count of Participants That Experience Progression-free Survival (PFS)
The amount of participants that survive one year after treatment with BBd and do not experience worsening disease.
Count of Participants That Experience Overall Survival (OS)
The amount of participants that start treatment with BBd and survive at least one year post treatment completion.

Full Information

First Posted
August 21, 2014
Last Updated
August 27, 2019
Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
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1. Study Identification

Unique Protocol Identification Number
NCT02224729
Brief Title
Bendamustine Hydrochloride, Bortezomib, and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma
Official Title
Phase II Study of Bendamustine, Bortezomib, and Dexamethasone (BBD) for Newly Diagnosed Patients With Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
August 25, 2014 (Actual)
Primary Completion Date
April 21, 2016 (Actual)
Study Completion Date
November 17, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage I Multiple Myeloma, Stage II Multiple Myeloma, Stage III Multiple Myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bendamustine, Bortezomib, Dexamethasone (Standard)
Arm Type
Experimental
Arm 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 Type
Drug
Intervention Name(s)
Bendamustine hydrochloride
Other Intervention Name(s)
Treakisym, Ribomustin, Levact, Treanda, SDX-105
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
Bortezomib
Other Intervention Name(s)
PS-341, Velcade, Cytomib
Intervention Description
Given SC
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Given PO
Primary Outcome Measure Information:
Title
Count of Participants That Experience Overall Response Following 4 Cycles of the Combination Regimen BBd
Description
ORR (partial remission or better) to induction therapy following 4 cycles of the combination regimen BBd.
Time Frame
At least 140 days
Secondary Outcome Measure Information:
Title
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
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.
Time Frame
Up to 1 year
Title
Count of Participants That Experience Very Good Partial Remission (VGPR)
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
Time Frame
Up to 1 year
Title
Count of Participants That Experience Progression-free Survival (PFS)
Description
The amount of participants that survive one year after treatment with BBd and do not experience worsening disease.
Time Frame
1 year
Title
Count of Participants That Experience Overall Survival (OS)
Description
The amount of participants that start treatment with BBd and survive at least one year post treatment completion.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 >= 18 years of age ECOG <= 3 Signed informed consent 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: Failure to sign informed consent Smoldering myeloma, monoclonal gammopathy of undetermined significance (MGUS), or plasma cell leukemia History of previously treated smoldering myeloma Grade 3 or above peripheral neuropathy Uncontrolled human immunodeficiency virus (HIV) Active hepatitis A, B or C Pregnant or lactating females Total bilirubin >3 times the upper limit of normal ASLT/ALT > 2.5 times the upper limit of normal
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joanne Filicko-O'Hara, MD
Organizational Affiliation
Sidney Kimmel Cancer Center at Thomas Jefferson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.JeffersonHospital.org
Description
Jefferson University Hospitals

Learn more about this trial

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

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