Trial Outcomes & Findings for Bendamustine Hydrochloride, Bortezomib, and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma (NCT NCT02224729)
NCT ID: NCT02224729
Last Updated: 2025-04-30
Results Overview
ORR (partial remission or better) to induction therapy following 4 cycles of the combination regimen BBd.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
At least 140 days
Results posted on
2025-04-30
Participant Flow
Participant milestones
| Measure |
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.
Bendamustine hydrochloride: Given IV
Bortezomib: Given SC
Dexamethasone: Given PO
|
|---|---|
|
Overall Study
STARTED
|
24
|
|
Overall Study
COMPLETED
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bendamustine Hydrochloride, Bortezomib, and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Bendamustine, Bortezomib, Dexamethasone (Standard)
n=24 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
24 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: At least 140 daysPopulation: 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)
ORR (partial remission or better) to induction therapy following 4 cycles of the combination regimen BBd.
Outcome measures
| Measure |
Bendamustine, Bortezomib, Dexamethasone (Standard)
n=20 Participants
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
|
|---|---|
|
Count of Participants That Experience Overall Response Following 4 Cycles of the Combination Regimen BBd
|
13 Participants
|
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: 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)
All adverse events are tracked during the course of the trial. Adverse events with a grade of 3-4 will be tracked and recorded.
Outcome measures
| Measure |
Bendamustine, Bortezomib, Dexamethasone (Standard)
n=20 Participants
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
|
|---|---|
|
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
|
22 Adverse Events
|
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: 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)
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
Outcome measures
| Measure |
Bendamustine, Bortezomib, Dexamethasone (Standard)
n=20 Participants
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
|
|---|---|
|
Count of Participants That Experience Very Good Partial Remission (VGPR)
|
9 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: 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)
The amount of participants that survive one year after treatment with BBd and do not experience worsening disease.
Outcome measures
| Measure |
Bendamustine, Bortezomib, Dexamethasone (Standard)
n=20 Participants
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
|
|---|---|
|
Count of Participants That Experience Progression-free Survival (PFS)
|
2 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: 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)
The amount of participants that start treatment with BBd and survive at least one year post treatment completion.
Outcome measures
| Measure |
Bendamustine, Bortezomib, Dexamethasone (Standard)
n=20 Participants
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
|
|---|---|
|
Count of Participants That Experience Overall Survival (OS)
|
2 Participants
|
Adverse Events
Bendamustine, Bortezomib, Dexamethasone (Standard)
Serious events: 9 serious events
Other events: 24 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Bendamustine, Bortezomib, Dexamethasone (Standard)
n=24 participants at risk
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
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Joint Function Pain
|
4.2%
1/24 • Number of events 1
|
|
Immune system disorders
Death- Anaphylactic Shock
|
4.2%
1/24 • Number of events 1
|
|
Blood and lymphatic system disorders
Hypercalcemia
|
4.2%
1/24 • Number of events 1
|
|
Blood and lymphatic system disorders
Gout
|
4.2%
1/24 • Number of events 1
|
|
Blood and lymphatic system disorders
Syncope episode
|
4.2%
1/24 • Number of events 3
|
|
Infections and infestations
Febrile Neutropenia
|
4.2%
1/24 • Number of events 1
|
|
Hepatobiliary disorders
Acute kidney injury
|
4.2%
1/24 • Number of events 2
|
|
General disorders
Failure to Thrive
|
4.2%
1/24 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
4.2%
1/24 • Number of events 1
|
|
Immune system disorders
Allergic Reaction
|
4.2%
1/24 • Number of events 1
|
Other adverse events
| Measure |
Bendamustine, Bortezomib, Dexamethasone (Standard)
n=24 participants at risk
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
|
|---|---|
|
Blood and lymphatic system disorders
Alkaline Phosphate increased
|
29.2%
7/24 • Number of events 9
|
|
Gastrointestinal disorders
Abdominal cramping
|
4.2%
1/24 • Number of events 1
|
|
Hepatobiliary disorders
Acute kidney injury
|
4.2%
1/24 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.2%
1/24 • Number of events 1
|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
12/24 • Number of events 16
|
|
Psychiatric disorders
Anorexia
|
20.8%
5/24 • Number of events 5
|
|
Blood and lymphatic system disorders
AST increase
|
8.3%
2/24 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
8/24 • Number of events 8
|
|
Skin and subcutaneous tissue disorders
Bruising
|
8.3%
2/24 • Number of events 2
|
|
General disorders
Change in taste
|
16.7%
4/24 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Chest pain
|
4.2%
1/24 • Number of events 1
|
|
General disorders
Confusion
|
4.2%
1/24 • Number of events 1
|
|
Eye disorders
Conjuctivitis
|
4.2%
1/24 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
25.0%
6/24 • Number of events 6
|
|
Blood and lymphatic system disorders
Creatinine increased
|
8.3%
2/24 • Number of events 2
|
|
Eye disorders
Decreased Visual Field
|
4.2%
1/24 • Number of events 1
|
|
Psychiatric disorders
Depression
|
12.5%
3/24 • Number of events 3
|
|
Gastrointestinal disorders
Diarrhea
|
20.8%
5/24 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Dry cough
|
12.5%
3/24 • Number of events 3
|
|
General disorders
Dry mouth
|
8.3%
2/24 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.2%
1/24 • Number of events 1
|
|
Gastrointestinal disorders
Dysphagia
|
4.2%
1/24 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.8%
5/24 • Number of events 6
|
|
General disorders
Edema
|
16.7%
4/24 • Number of events 4
|
|
Blood and lymphatic system disorders
Epistaxis
|
4.2%
1/24 • Number of events 1
|
|
General disorders
Fatigue
|
54.2%
13/24 • Number of events 14
|
|
Immune system disorders
Flu like symptoms
|
4.2%
1/24 • Number of events 1
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
12.5%
3/24 • Number of events 3
|
|
General disorders
Hand pain
|
4.2%
1/24 • Number of events 1
|
|
General disorders
Headache
|
12.5%
3/24 • Number of events 4
|
|
General disorders
Hiccups
|
4.2%
1/24 • Number of events 2
|
|
General disorders
Hot flashes
|
4.2%
1/24 • Number of events 1
|
|
Blood and lymphatic system disorders
Hypercalcemia
|
16.7%
4/24 • Number of events 4
|
|
Blood and lymphatic system disorders
Hyperglycemia
|
16.7%
4/24 • Number of events 4
|
|
Blood and lymphatic system disorders
Hyperkalemia
|
12.5%
3/24 • Number of events 3
|
|
Blood and lymphatic system disorders
Hypermagnesemia
|
4.2%
1/24 • Number of events 1
|
|
Blood and lymphatic system disorders
Hypertension
|
12.5%
3/24 • Number of events 3
|
|
Blood and lymphatic system disorders
Hyperuricemia
|
12.5%
3/24 • Number of events 3
|
|
Blood and lymphatic system disorders
Hypoalbuminemia
|
12.5%
3/24 • Number of events 3
|
|
Blood and lymphatic system disorders
Hypocalcemia
|
20.8%
5/24 • Number of events 5
|
|
Blood and lymphatic system disorders
Hypokalemia
|
12.5%
3/24 • Number of events 4
|
|
Blood and lymphatic system disorders
Hypomagnesium
|
8.3%
2/24 • Number of events 2
|
|
Blood and lymphatic system disorders
Hyponatremia
|
12.5%
3/24 • Number of events 3
|
|
Blood and lymphatic system disorders
Hypophosphatemia
|
16.7%
4/24 • Number of events 5
|
|
Blood and lymphatic system disorders
Hypotension
|
8.3%
2/24 • Number of events 2
|
|
Infections and infestations
Infection site reaction
|
16.7%
4/24 • Number of events 4
|
|
General disorders
Insomnia
|
12.5%
3/24 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Leg Pain (spasm)
|
4.2%
1/24 • Number of events 1
|
|
General disorders
Light headedness
|
4.2%
1/24 • Number of events 1
|
|
General disorders
Loss of appetite
|
8.3%
2/24 • Number of events 2
|
|
Blood and lymphatic system disorders
Lymphocyte count decreased
|
25.0%
6/24 • Number of events 15
|
|
General disorders
Nasal Congestion
|
8.3%
2/24 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
37.5%
9/24 • Number of events 10
|
|
Nervous system disorders
Neuropathy
|
8.3%
2/24 • Number of events 2
|
|
Blood and lymphatic system disorders
Orthostatic hypotension
|
4.2%
1/24 • Number of events 1
|
|
General disorders
Pain
|
12.5%
3/24 • Number of events 4
|
|
General disorders
Pain at port site
|
4.2%
1/24 • Number of events 1
|
|
General disorders
Pain Knee
|
4.2%
1/24 • Number of events 2
|
|
General disorders
Pain shoulder
|
4.2%
1/24 • Number of events 1
|
|
General disorders
Pain- side of face
|
4.2%
1/24 • Number of events 1
|
|
Cardiac disorders
Palpitations
|
4.2%
1/24 • Number of events 1
|
|
Nervous system disorders
Paresthesia
|
4.2%
1/24 • Number of events 1
|
|
Nervous system disorders
peripheral motor neuropathy
|
4.2%
1/24 • Number of events 1
|
|
Blood and lymphatic system disorders
Platelet Count decreased
|
8.3%
2/24 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
4.2%
1/24 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash unspecified
|
4.2%
1/24 • Number of events 1
|
|
General disorders
Rib pain
|
8.3%
2/24 • Number of events 2
|
|
Infections and infestations
Sinusitis
|
4.2%
1/24 • Number of events 2
|
|
General disorders
Sore Throat
|
8.3%
2/24 • Number of events 2
|
|
General disorders
Soreness
|
4.2%
1/24 • Number of events 2
|
|
Gastrointestinal disorders
Stomach Pain
|
4.2%
1/24 • Number of events 1
|
|
Renal and urinary disorders
Urinary Frequency
|
8.3%
2/24 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Weakness
|
4.2%
1/24 • Number of events 1
|
|
Blood and lymphatic system disorders
White blood cell count decreased
|
29.2%
7/24 • Number of events 14
|
|
Reproductive system and breast disorders
Swelling L- Breast
|
4.2%
1/24 • Number of events 1
|
|
Renal and urinary disorders
Urinary Tract infection
|
4.2%
1/24 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.2%
1/24 • Number of events 1
|
|
Gastrointestinal disorders
Indigestion
|
4.2%
1/24 • Number of events 1
|
|
Renal and urinary disorders
Hematuria
|
8.3%
2/24 • Number of events 2
|
|
Infections and infestations
Gum infection
|
4.2%
1/24 • Number of events 1
|
|
General disorders
Fall
|
4.2%
1/24 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
4.2%
1/24 • Number of events 1
|
|
Ear and labyrinth disorders
Ear infection
|
4.2%
1/24 • Number of events 2
|
|
Blood and lymphatic system disorders
ANC increased
|
4.2%
1/24 • Number of events 1
|
|
General disorders
Allergic Rhinitis
|
4.2%
1/24 • Number of events 1
|
Additional Information
Dr. Joanne Filicko, O'Hara
Sidney Kimmel Cancer Center at Thomas Jefferson University
Phone: 215-955-8874
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place