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

NCT02224729 | Completed Phase 2 Results DMC

• 3 other identifiers: 14D.3002014-025JT 6192
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Stage I Multiple Myeloma; Stage II Multiple Myeloma; Stage III Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• 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.

  At least 140 days

Secondary Outcomes (4)

• 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

  Up to 1 year

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

  Up to 1 year

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

  1 year

• Count of Participants That Experience Overall Survival (OS)

  1 year

Study Arms (1)

Bendamustine, Bortezomib, Dexamethasone (Standard)

EXPERIMENTAL

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; Drug: Bortezomib; Drug: Dexamethasone

Interventions

Bendamustine hydrochloride DRUG

Given IV

Also known as: Treakisym, Ribomustin, Levact, Treanda, SDX-105

Bendamustine, Bortezomib, Dexamethasone (Standard)

Bortezomib DRUG

Given SC

Also known as: PS-341, Velcade, Cytomib

Bendamustine, Bortezomib, Dexamethasone (Standard)

Dexamethasone DRUG

Given PO

Bendamustine, Bortezomib, Dexamethasone (Standard)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• 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

Sponsors & Collaborators

• Sidney Kimmel Cancer Center at Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Links

• Jefferson University Hospitals

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Bendamustine Hydrochloride; Bortezomib; Dexamethasone

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Pyrazines; Heterocyclic Compounds, 1-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Dr. Joanne Filicko, O'Hara
• Organization: Sidney Kimmel Cancer Center at Thomas Jefferson University

joanne.filicko@jeffersron.edu

215-955-8874

Study Officials

• Joanne Filicko-O'Hara, MD

  Sidney Kimmel Cancer Center at Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2014
• First Posted: August 25, 2014
• Study Start: August 25, 2014
• Primary Completion: April 21, 2016
• Study Completion: November 17, 2018
• Last Updated: April 30, 2025
• Results First Posted: June 7, 2018

Record last verified: 2025-04

Locations

US (1)