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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 )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Stage I Multiple Myeloma
Stage II Multiple Myeloma
Stage III Multiple Myeloma
Interventions Drug: Bendamustine hydrochloride
Drug: Bortezomib
Drug: Dexamethasone
Enrollment 24
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bendamustine, Bortezomib, Dexamethasone (Standard)
Hide Arm/Group 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.

Bendamustine hydrochloride: Given IV

Bortezomib: Given SC

Dexamethasone: Given PO

Period Title: Overall Study
Started 24
Completed 24
Not Completed 0
Arm/Group Title Bendamustine, Bortezomib, Dexamethasone (Standard)
Hide Arm/Group 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.

Bendamustine hydrochloride: Given IV

Bortezomib: Given SC

Dexamethasone: Given PO

Overall Number of Baseline Participants 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
<=18 years
0
   0.0%
Between 18 and 65 years
18
  75.0%
>=65 years
6
  25.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
Female
16
  66.7%
Male
8
  33.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
24
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
14
  58.3%
White
10
  41.7%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 24 participants
24
 100.0%
1.Primary Outcome
Title Count of Participants That Experience Overall Response Following 4 Cycles of the Combination Regimen BBd
Hide Description ORR (partial remission or better) to induction therapy following 4 cycles of the combination regimen BBd.
Time Frame At least 140 days
Hide Outcome Measure Data
Hide Analysis Population Description
4 subjects were not evaluable – (1 didn’t get any therapy on study, 1 received only first cycle and 2 developed medical issues that took them off study during the first cycle)
Arm/Group Title Bendamustine, Bortezomib, Dexamethasone (Standard)
Hide Arm/Group 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.

Bendamustine hydrochloride: Given IV

Bortezomib: Given SC

Dexamethasone: Given PO

Overall Number of Participants Analyzed 20
Measure Type: Count of Participants
Unit of Measure: Participants
13
  65.0%
2.Secondary Outcome
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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
4 were not evaluable – (1 didn’t get any therapy on study, 1 received only first cycle and 2 developed medical issues that took them off study during the first cycle)
Arm/Group Title Bendamustine, Bortezomib, Dexamethasone (Standard)
Hide Arm/Group 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.

Bendamustine hydrochloride: Given IV

Bortezomib: Given SC

Dexamethasone: Given PO

Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: Adverse Events
22
3.Secondary Outcome
Title Count of Participants That Experience Very Good Partial Remission (VGPR)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
4 were not evaluable – (1 didn’t get any therapy on study, 1 received only first cycle and 2 developed medical issues that took them off study during the first cycle)
Arm/Group Title Bendamustine, Bortezomib, Dexamethasone (Standard)
Hide Arm/Group 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.

Bendamustine hydrochloride: Given IV

Bortezomib: Given SC

Dexamethasone: Given PO

Overall Number of Participants Analyzed 20
Measure Type: Count of Participants
Unit of Measure: Participants
9
  45.0%
4.Secondary Outcome
Title Count of Participants That Experience Progression-free Survival (PFS)
Hide Description The amount of participants that survive one year after treatment with BBd and do not experience worsening disease.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
4 were not evaluable – (1 didn’t get any therapy on study, 1 received only first cycle and 2 developed medical issues that took them off study during the first cycle)
Arm/Group Title Bendamustine, Bortezomib, Dexamethasone (Standard)
Hide Arm/Group 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.

Bendamustine hydrochloride: Given IV

Bortezomib: Given SC

Dexamethasone: Given PO

Overall Number of Participants Analyzed 20
Measure Type: Count of Participants
Unit of Measure: Participants
2
  10.0%
5.Secondary Outcome
Title Count of Participants That Experience Overall Survival (OS)
Hide Description The amount of participants that start treatment with BBd and survive at least one year post treatment completion.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
4 were not evaluable – (1 didn’t get any therapy on study, 1 received only first cycle and 2 developed medical issues that took them off study during the first cycle)
Arm/Group Title Bendamustine, Bortezomib, Dexamethasone (Standard)
Hide Arm/Group 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.

Bendamustine hydrochloride: Given IV

Bortezomib: Given SC

Dexamethasone: Given PO

Overall Number of Participants Analyzed 20
Measure Type: Count of Participants
Unit of Measure: Participants
2
  10.0%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bendamustine, Bortezomib, Dexamethasone (Standard)
Hide Arm/Group 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.

Bendamustine hydrochloride: Given IV

Bortezomib: Given SC

Dexamethasone: Given PO

All-Cause Mortality
Bendamustine, Bortezomib, Dexamethasone (Standard)
Affected / at Risk (%)
Total   1/24 (4.17%)    
Show Serious Adverse Events Hide Serious Adverse Events
Bendamustine, Bortezomib, Dexamethasone (Standard)
Affected / at Risk (%) # Events
Total   9/24 (37.50%)    
Blood and lymphatic system disorders   
Hypercalcemia *  1/24 (4.17%)  1
Gout *  1/24 (4.17%)  1
Syncope episode *  1/24 (4.17%)  3
General disorders   
Failure to Thrive *  1/24 (4.17%)  1
Hepatobiliary disorders   
Acute kidney injury *  1/24 (4.17%)  2
Immune system disorders   
Death- Anaphylactic Shock *  1/24 (4.17%)  1
Allergic Reaction *  1/24 (4.17%)  1
Infections and infestations   
Febrile Neutropenia *  1/24 (4.17%)  1
Musculoskeletal and connective tissue disorders   
Joint Function Pain *  1/24 (4.17%)  1
Respiratory, thoracic and mediastinal disorders   
Pneumonia *  1/24 (4.17%)  1
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Bendamustine, Bortezomib, Dexamethasone (Standard)
Affected / at Risk (%) # Events
Total   24/24 (100.00%)    
Blood and lymphatic system disorders   
Alkaline Phosphate increased *  7/24 (29.17%)  9
Anemia *  12/24 (50.00%)  16
AST increase *  2/24 (8.33%)  2
Creatinine increased *  2/24 (8.33%)  2
Epistaxis *  1/24 (4.17%)  1
Hypercalcemia *  4/24 (16.67%)  4
Hyperglycemia *  4/24 (16.67%)  4
Hyperkalemia *  3/24 (12.50%)  3
Hypermagnesemia *  1/24 (4.17%)  1
Hypertension *  3/24 (12.50%)  3
Hyperuricemia *  3/24 (12.50%)  3
Hypoalbuminemia *  3/24 (12.50%)  3
Hypocalcemia *  5/24 (20.83%)  5
Hypokalemia *  3/24 (12.50%)  4
Hypomagnesium *  2/24 (8.33%)  2
Hyponatremia *  3/24 (12.50%)  3
Hypophosphatemia *  4/24 (16.67%)  5
Hypotension *  2/24 (8.33%)  2
Lymphocyte count decreased *  6/24 (25.00%)  15
Orthostatic hypotension *  1/24 (4.17%)  1
Platelet Count decreased *  2/24 (8.33%)  3
White blood cell count decreased *  7/24 (29.17%)  14
ANC increased *  1/24 (4.17%)  1
Cardiac disorders   
Palpitations *  1/24 (4.17%)  1
Ear and labyrinth disorders   
Ear infection *  1/24 (4.17%)  2
Eye disorders   
Conjuctivitis *  1/24 (4.17%)  1
Decreased Visual Field *  1/24 (4.17%)  1
Gastrointestinal disorders   
Abdominal cramping *  1/24 (4.17%)  1
Constipation *  6/24 (25.00%)  6
Diarrhea *  5/24 (20.83%)  8
Dysphagia *  1/24 (4.17%)  1
Gastroesophageal reflux disease *  3/24 (12.50%)  3
Nausea *  9/24 (37.50%)  10
Stomach Pain *  1/24 (4.17%)  1
Indigestion *  1/24 (4.17%)  1
General disorders   
Change in taste *  4/24 (16.67%)  4
Confusion *  1/24 (4.17%)  1
Dry mouth *  2/24 (8.33%)  2
Edema *  4/24 (16.67%)  4
Fatigue *  13/24 (54.17%)  14
Hand pain *  1/24 (4.17%)  1
Headache *  3/24 (12.50%)  4
Hiccups *  1/24 (4.17%)  2
Hot flashes *  1/24 (4.17%)  1
Insomnia *  3/24 (12.50%)  3
Light headedness *  1/24 (4.17%)  1
Loss of appetite *  2/24 (8.33%)  2
Nasal Congestion *  2/24 (8.33%)  2
Pain *  3/24 (12.50%)  4
Pain at port site *  1/24 (4.17%)  1
Pain Knee *  1/24 (4.17%)  2
Pain shoulder *  1/24 (4.17%)  1
Pain- side of face *  1/24 (4.17%)  1
Rib pain *  2/24 (8.33%)  2
Sore Throat *  2/24 (8.33%)  2
Soreness *  1/24 (4.17%)  2
Fall *  1/24 (4.17%)  1
Allergic Rhinitis *  1/24 (4.17%)  1
Hepatobiliary disorders   
Acute kidney injury *  1/24 (4.17%)  1
Immune system disorders   
Flu like symptoms *  1/24 (4.17%)  1
Infections and infestations   
Infection site reaction *  4/24 (16.67%)  4
Sinusitis *  1/24 (4.17%)  2
Gum infection *  1/24 (4.17%)  1
Musculoskeletal and connective tissue disorders   
Back pain *  8/24 (33.33%)  8
Chest pain *  1/24 (4.17%)  1
Leg Pain (spasm) *  1/24 (4.17%)  1
Weakness *  1/24 (4.17%)  1
Neck pain *  1/24 (4.17%)  1
Flank pain *  1/24 (4.17%)  1
Nervous system disorders   
Neuropathy *  2/24 (8.33%)  2
Paresthesia *  1/24 (4.17%)  1
peripheral motor neuropathy *  1/24 (4.17%)  1
Psychiatric disorders   
Anorexia *  5/24 (20.83%)  5
Depression *  3/24 (12.50%)  3
Renal and urinary disorders   
Urinary Frequency *  2/24 (8.33%)  2
Urinary Tract infection *  1/24 (4.17%)  1
Hematuria *  2/24 (8.33%)  2
Reproductive system and breast disorders   
Swelling L- Breast *  1/24 (4.17%)  1
Respiratory, thoracic and mediastinal disorders   
Dry cough *  3/24 (12.50%)  3
Dyspnea *  5/24 (20.83%)  6
Productive Cough *  1/24 (4.17%)  1
Skin and subcutaneous tissue disorders   
Alopecia *  1/24 (4.17%)  1
Bruising *  2/24 (8.33%)  2
Dry skin *  1/24 (4.17%)  1
Rash unspecified *  1/24 (4.17%)  1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Joanne Filicko, O'Hara
Organization: Sidney Kimmel Cancer Center at Thomas Jefferson University
Phone: 215-955-8874
EMail: joanne.filicko@jeffersron.edu
Layout table for additonal information
Responsible Party: Thomas Jefferson University ( 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 Submitted: August 21, 2014
First Posted: August 25, 2014
Results First Submitted: May 7, 2018
Results First Posted: June 7, 2018
Last Update Posted: September 13, 2019