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

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ClinicalTrials.gov Identifier: NCT02224729
Recruitment Status : Completed
First Posted : August 25, 2014
Results First Posted : June 7, 2018
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )

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.

Condition or disease Intervention/treatment Phase
Stage I Multiple Myeloma Stage II Multiple Myeloma Stage III Multiple Myeloma Drug: Bendamustine hydrochloride Drug: Bortezomib Drug: Dexamethasone Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Bendamustine, Bortezomib, and Dexamethasone (BBD) for Newly Diagnosed Patients With Multiple Myeloma
Actual Study Start Date : August 25, 2014
Actual Primary Completion Date : April 21, 2016
Actual Study Completion Date : November 17, 2018


Arm Intervention/treatment
Experimental: Bendamustine, Bortezomib, Dexamethasone (Standard)
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.
Drug: Bendamustine hydrochloride
Given IV
Other Names:
  • Treakisym
  • Ribomustin
  • Levact
  • Treanda
  • SDX-105

Drug: Bortezomib
Given SC
Other Names:
  • PS-341
  • Velcade
  • Cytomib

Drug: Dexamethasone
Given PO




Primary Outcome Measures :
  1. Count of Participants That Experience Overall Response Following 4 Cycles of the Combination Regimen BBd [ Time Frame: At least 140 days ]
    ORR (partial remission or better) to induction therapy following 4 cycles of the combination regimen BBd.


Secondary Outcome Measures :
  1. 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 ]
    All adverse events are tracked during the course of the trial. Adverse events with a grade of 3-4 will be tracked and recorded.

  2. Count of Participants That Experience Very Good Partial Remission (VGPR) [ Time Frame: Up to 1 year ]
    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

  3. Count of Participants That Experience Progression-free Survival (PFS) [ Time Frame: 1 year ]
    The amount of participants that survive one year after treatment with BBd and do not experience worsening disease.

  4. Count of Participants That Experience Overall Survival (OS) [ Time Frame: 1 year ]
    The amount of participants that start treatment with BBd and survive at least one year post treatment completion.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02224729


Locations
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United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Sidney Kimmel Cancer Center at Thomas Jefferson University
Investigators
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Principal Investigator: Joanne Filicko-O'Hara, MD Sidney Kimmel Cancer Center at Thomas Jefferson University

Additional Information:
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Responsible Party: Sidney Kimmel Cancer Center at Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT02224729     History of Changes
Other Study ID Numbers: 14D.300
2014-025 ( Other Identifier: CCRRC )
First Posted: August 25, 2014    Key Record Dates
Results First Posted: June 7, 2018
Last Update Posted: September 13, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
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Bendamustine Hydrochloride
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone
Dexamethasone acetate
Bortezomib
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents