Trial Outcomes & Findings for Optimising Renal Outcome in Myeloma Renal Failure (NCT NCT02424851)
NCT ID: NCT02424851
Last Updated: 2022-01-27
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
31 participants
Primary outcome timeframe
End of week 6 (after receiving two cycles of therapy)
Results posted on
2022-01-27
Participant Flow
Participant milestones
| Measure |
Arm A (BBD)
Bortezomib, Bendamustine and Dexamethasone
Bortezomib: 1.3 mg/m2 subcutaneously\* days 1, 4, 8 and 11 of each cycle. Number of cycles: Four 21 day cycles (participants not suitable for ASCT (autologous stem cell transplant) will continue up to 6 cycles on the treatment regimen to which they were randomised).
\*intravenous infusion available in case of patient intolerance to subcutaneous bortezomib
Bendamustine: 60 mg/m2 i.v. days 1 and 8 of each cycle. Four 21 day cycles (participants not suitable for ASCT will continue up to 6 cycles on the treatment regimen to which they were randomised)
Dexamethasone: 40mg orally days 1-2, 4-5, 8-9 and 11-12 of each cycle
|
Arm B (BTD)
Thalidomide, Bendamustine and Dexamethasone
Thalidomide: 100 mg daily orally, preferably at night, days 1-21 of each cycle. Four 21 day cycles (participants not suitable for ASCT will continue up to 6 cycles on the treatment regimen to which they were randomised)
Bendamustine: 60 mg/m2 i.v. days 1 and 8 of each cycle. Four 21 day cycles (participants not suitable for ASCT will continue up to 6 cycles on the treatment regimen to which they were randomised)
Dexamethasone: 40mg orally days 1-2, 4-5, 8-9 and 11-12 of each cycle
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
15
|
|
Overall Study
COMPLETED
|
14
|
12
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Arm A (BBD)
n=16 Participants
Bortezomib, Bendamustine and Dexamethasone
Bortezomib: 1.3 mg/m2 subcutaneously\* days 1, 4, 8 and 11 of each cycle. Number of cycles: Four 21 day cycles (participants not suitable for ASCT (autologous stem cell transplant) will continue up to 6 cycles on the treatment regimen to which they were randomised).
\*intravenous infusion available in case of patient intolerance to subcutaneous bortezomib
Bendamustine: 60 mg/m2 i.v. days 1 and 8 of each cycle. Four 21 day cycles (participants not suitable for ASCT will continue up to 6 cycles on the treatment regimen to which they were randomised)
Dexamethasone: 40mg orally days 1-2, 4-5, 8-9 and 11-12 of each cycle
|
Arm B (BTD)
n=15 Participants
Thalidomide, Bendamustine and Dexamethasone
Thalidomide: 100 mg daily orally, preferably at night, days 1-21 of each cycle. Four 21 day cycles (participants not suitable for ASCT will continue up to 6 cycles on the treatment regimen to which they were randomised)
Bendamustine: 60 mg/m2 i.v. days 1 and 8 of each cycle. Four 21 day cycles (participants not suitable for ASCT will continue up to 6 cycles on the treatment regimen to which they were randomised)
Dexamethasone: 40mg orally days 1-2, 4-5, 8-9 and 11-12 of each cycle
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
≤70 years
|
8 Participants
n=16 Participants
|
8 Participants
n=15 Participants
|
16 Participants
n=31 Participants
|
|
Age, Customized
>70 years
|
8 Participants
n=16 Participants
|
7 Participants
n=15 Participants
|
15 Participants
n=31 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=16 Participants
|
6 Participants
n=15 Participants
|
14 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=16 Participants
|
9 Participants
n=15 Participants
|
17 Participants
n=31 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United Kingdom
|
16 participants
n=16 Participants
|
15 participants
n=15 Participants
|
31 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: End of week 6 (after receiving two cycles of therapy)Population: The primary endpoint of serum free light chain response was assessed in 30 patients where samples were available at screening and the end of two cycles of trial treatment.
Outcome measures
| Measure |
Arm A (BBD)
n=16 Participants
Bortezomib, Bendamustine and Dexamethasone
Bortezomib: 1.3 mg/m2 subcutaneously\* days 1, 4, 8 and 11 of each cycle. Number of cycles: Four 21 day cycles (participants not suitable for ASCT (autologous stem cell transplant) will continue up to 6 cycles on the treatment regimen to which they were randomised).
\*intravenous infusion available in case of patient intolerance to subcutaneous bortezomib
Bendamustine: 60 mg/m2 i.v. days 1 and 8 of each cycle. Four 21 day cycles (participants not suitable for ASCT will continue up to 6 cycles on the treatment regimen to which they were randomised)
Dexamethasone: 40mg orally days 1-2, 4-5, 8-9 and 11-12 of each cycle
|
Arm B (BTD)
n=14 Participants
Thalidomide, Bendamustine and Dexamethasone
Thalidomide: 100 mg daily orally, preferably at night, days 1-21 of each cycle. Four 21 day cycles (participants not suitable for ASCT will continue up to 6 cycles on the treatment regimen to which they were randomised)
Bendamustine: 60 mg/m2 i.v. days 1 and 8 of each cycle. Four 21 day cycles (participants not suitable for ASCT will continue up to 6 cycles on the treatment regimen to which they were randomised)
Dexamethasone: 40mg orally days 1-2, 4-5, 8-9 and 11-12 of each cycle
|
|---|---|---|
|
Number of Participants With >50% Reduction From Baseline in Serum Free Light Chain
|
13 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: End of week 12 (after receiving 4 cycles of therapy)Population: Renal response in accordance with IMWG criteria was assessed in 20 patients with eGFR and creatinine clearance data recorded at screening and at the end of four cycles of trial treatment.
Outcome measures
| Measure |
Arm A (BBD)
n=16 Participants
Bortezomib, Bendamustine and Dexamethasone
Bortezomib: 1.3 mg/m2 subcutaneously\* days 1, 4, 8 and 11 of each cycle. Number of cycles: Four 21 day cycles (participants not suitable for ASCT (autologous stem cell transplant) will continue up to 6 cycles on the treatment regimen to which they were randomised).
\*intravenous infusion available in case of patient intolerance to subcutaneous bortezomib
Bendamustine: 60 mg/m2 i.v. days 1 and 8 of each cycle. Four 21 day cycles (participants not suitable for ASCT will continue up to 6 cycles on the treatment regimen to which they were randomised)
Dexamethasone: 40mg orally days 1-2, 4-5, 8-9 and 11-12 of each cycle
|
Arm B (BTD)
n=15 Participants
Thalidomide, Bendamustine and Dexamethasone
Thalidomide: 100 mg daily orally, preferably at night, days 1-21 of each cycle. Four 21 day cycles (participants not suitable for ASCT will continue up to 6 cycles on the treatment regimen to which they were randomised)
Bendamustine: 60 mg/m2 i.v. days 1 and 8 of each cycle. Four 21 day cycles (participants not suitable for ASCT will continue up to 6 cycles on the treatment regimen to which they were randomised)
Dexamethasone: 40mg orally days 1-2, 4-5, 8-9 and 11-12 of each cycle
|
|---|---|---|
|
Number of Participants With Different Renal Responses to Treatment
Complete/partial response
|
5 Participants
|
1 Participants
|
|
Number of Participants With Different Renal Responses to Treatment
Minor response
|
3 Participants
|
7 Participants
|
|
Number of Participants With Different Renal Responses to Treatment
No response
|
3 Participants
|
1 Participants
|
|
Number of Participants With Different Renal Responses to Treatment
Not evaluable
|
5 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: End of weeks 3, 6, 9, 12 (after receiving 4 cycles of therapy), 30 days after final treatment and 12 months after randomisationOutcome measures
| Measure |
Arm A (BBD)
n=16 Participants
Bortezomib, Bendamustine and Dexamethasone
Bortezomib: 1.3 mg/m2 subcutaneously\* days 1, 4, 8 and 11 of each cycle. Number of cycles: Four 21 day cycles (participants not suitable for ASCT (autologous stem cell transplant) will continue up to 6 cycles on the treatment regimen to which they were randomised).
\*intravenous infusion available in case of patient intolerance to subcutaneous bortezomib
Bendamustine: 60 mg/m2 i.v. days 1 and 8 of each cycle. Four 21 day cycles (participants not suitable for ASCT will continue up to 6 cycles on the treatment regimen to which they were randomised)
Dexamethasone: 40mg orally days 1-2, 4-5, 8-9 and 11-12 of each cycle
|
Arm B (BTD)
n=15 Participants
Thalidomide, Bendamustine and Dexamethasone
Thalidomide: 100 mg daily orally, preferably at night, days 1-21 of each cycle. Four 21 day cycles (participants not suitable for ASCT will continue up to 6 cycles on the treatment regimen to which they were randomised)
Bendamustine: 60 mg/m2 i.v. days 1 and 8 of each cycle. Four 21 day cycles (participants not suitable for ASCT will continue up to 6 cycles on the treatment regimen to which they were randomised)
Dexamethasone: 40mg orally days 1-2, 4-5, 8-9 and 11-12 of each cycle
|
|---|---|---|
|
Haematological and Non-haematological Toxicity in Both Treatment Arms
Serious adverse events
|
2 Events
|
0 Events
|
|
Haematological and Non-haematological Toxicity in Both Treatment Arms
Adverse events
|
3 Events
|
6 Events
|
SECONDARY outcome
Timeframe: 1 month post end of treatment and 1 year post randomisationOutcome measures
| Measure |
Arm A (BBD)
n=16 Participants
Bortezomib, Bendamustine and Dexamethasone
Bortezomib: 1.3 mg/m2 subcutaneously\* days 1, 4, 8 and 11 of each cycle. Number of cycles: Four 21 day cycles (participants not suitable for ASCT (autologous stem cell transplant) will continue up to 6 cycles on the treatment regimen to which they were randomised).
\*intravenous infusion available in case of patient intolerance to subcutaneous bortezomib
Bendamustine: 60 mg/m2 i.v. days 1 and 8 of each cycle. Four 21 day cycles (participants not suitable for ASCT will continue up to 6 cycles on the treatment regimen to which they were randomised)
Dexamethasone: 40mg orally days 1-2, 4-5, 8-9 and 11-12 of each cycle
|
Arm B (BTD)
n=15 Participants
Thalidomide, Bendamustine and Dexamethasone
Thalidomide: 100 mg daily orally, preferably at night, days 1-21 of each cycle. Four 21 day cycles (participants not suitable for ASCT will continue up to 6 cycles on the treatment regimen to which they were randomised)
Bendamustine: 60 mg/m2 i.v. days 1 and 8 of each cycle. Four 21 day cycles (participants not suitable for ASCT will continue up to 6 cycles on the treatment regimen to which they were randomised)
Dexamethasone: 40mg orally days 1-2, 4-5, 8-9 and 11-12 of each cycle
|
|---|---|---|
|
Overall Survival
|
9 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: End of 2nd treatment cycle, week 6Outcome measures
| Measure |
Arm A (BBD)
n=15 Participants
Bortezomib, Bendamustine and Dexamethasone
Bortezomib: 1.3 mg/m2 subcutaneously\* days 1, 4, 8 and 11 of each cycle. Number of cycles: Four 21 day cycles (participants not suitable for ASCT (autologous stem cell transplant) will continue up to 6 cycles on the treatment regimen to which they were randomised).
\*intravenous infusion available in case of patient intolerance to subcutaneous bortezomib
Bendamustine: 60 mg/m2 i.v. days 1 and 8 of each cycle. Four 21 day cycles (participants not suitable for ASCT will continue up to 6 cycles on the treatment regimen to which they were randomised)
Dexamethasone: 40mg orally days 1-2, 4-5, 8-9 and 11-12 of each cycle
|
Arm B (BTD)
n=13 Participants
Thalidomide, Bendamustine and Dexamethasone
Thalidomide: 100 mg daily orally, preferably at night, days 1-21 of each cycle. Four 21 day cycles (participants not suitable for ASCT will continue up to 6 cycles on the treatment regimen to which they were randomised)
Bendamustine: 60 mg/m2 i.v. days 1 and 8 of each cycle. Four 21 day cycles (participants not suitable for ASCT will continue up to 6 cycles on the treatment regimen to which they were randomised)
Dexamethasone: 40mg orally days 1-2, 4-5, 8-9 and 11-12 of each cycle
|
|---|---|---|
|
Renal Response After Two Cycles of Trial Treatment
Partial response
|
2 Participants
|
0 Participants
|
|
Renal Response After Two Cycles of Trial Treatment
Minor response
|
9 Participants
|
7 Participants
|
|
Renal Response After Two Cycles of Trial Treatment
No repsonse
|
4 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Baseline and 1 month follow upThe EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension is scored on a scale of 1 to 3: 1 (no problems), 2 (some problems), and 3 (extreme problems). Higher score equates to a worse outcome. As stated in the official EQ-5D user guide, patient responses to the 5 questions were converted into a single index value as per Dolan P (1997). Modeling valuations for EuroQol health states. Med Care 35(11):1095-108. These index values, with country specific value sets, facilitate the calculation of quality-adjusted life years (QALYs) that are used to inform economic evaluations of health care interventions. In the UK, the values range from -0.594 to +1.
Outcome measures
| Measure |
Arm A (BBD)
n=8 Participants
Bortezomib, Bendamustine and Dexamethasone
Bortezomib: 1.3 mg/m2 subcutaneously\* days 1, 4, 8 and 11 of each cycle. Number of cycles: Four 21 day cycles (participants not suitable for ASCT (autologous stem cell transplant) will continue up to 6 cycles on the treatment regimen to which they were randomised).
\*intravenous infusion available in case of patient intolerance to subcutaneous bortezomib
Bendamustine: 60 mg/m2 i.v. days 1 and 8 of each cycle. Four 21 day cycles (participants not suitable for ASCT will continue up to 6 cycles on the treatment regimen to which they were randomised)
Dexamethasone: 40mg orally days 1-2, 4-5, 8-9 and 11-12 of each cycle
|
Arm B (BTD)
n=9 Participants
Thalidomide, Bendamustine and Dexamethasone
Thalidomide: 100 mg daily orally, preferably at night, days 1-21 of each cycle. Four 21 day cycles (participants not suitable for ASCT will continue up to 6 cycles on the treatment regimen to which they were randomised)
Bendamustine: 60 mg/m2 i.v. days 1 and 8 of each cycle. Four 21 day cycles (participants not suitable for ASCT will continue up to 6 cycles on the treatment regimen to which they were randomised)
Dexamethasone: 40mg orally days 1-2, 4-5, 8-9 and 11-12 of each cycle
|
|---|---|---|
|
Quality of Life Measured by the EQ-5D-3L Questionnaire at Baseline and 1 Month Follow up
Baseline
|
0.72 Units on a scale
Standard Deviation 0.15
|
0.69 Units on a scale
Standard Deviation 0.35
|
|
Quality of Life Measured by the EQ-5D-3L Questionnaire at Baseline and 1 Month Follow up
1 month FU
|
0.69 Units on a scale
Standard Deviation 0.19
|
0.80 Units on a scale
Standard Deviation 0.28
|
Adverse Events
Arm A (BBD)
Serious events: 11 serious events
Other events: 15 other events
Deaths: 7 deaths
Arm B (BTD)
Serious events: 9 serious events
Other events: 11 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Arm A (BBD)
n=16 participants at risk
Bortezomib, Bendamustine and Dexamethasone
Bortezomib: 1.3 mg/m2 subcutaneously\* days 1, 4, 8 and 11 of each cycle. Number of cycles: Four 21 day cycles (participants not suitable for ASCT (autologous stem cell transplant) will continue up to 6 cycles on the treatment regimen to which they were randomised).
\*intravenous infusion available in case of patient intolerance to subcutaneous bortezomib
Bendamustine: 60 mg/m2 i.v. days 1 and 8 of each cycle. Four 21 day cycles (participants not suitable for ASCT will continue up to 6 cycles on the treatment regimen to which they were randomised)
Dexamethasone: 40mg orally days 1-2, 4-5, 8-9 and 11-12 of each cycle
|
Arm B (BTD)
n=15 participants at risk
Thalidomide, Bendamustine and Dexamethasone
Thalidomide: 100 mg daily orally, preferably at night, days 1-21 of each cycle. Four 21 day cycles (participants not suitable for ASCT will continue up to 6 cycles on the treatment regimen to which they were randomised)
Bendamustine: 60 mg/m2 i.v. days 1 and 8 of each cycle. Four 21 day cycles (participants not suitable for ASCT will continue up to 6 cycles on the treatment regimen to which they were randomised)
Dexamethasone: 40mg orally days 1-2, 4-5, 8-9 and 11-12 of each cycle
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/16 • 4 years, 2 months.
|
6.7%
1/15 • Number of events 1 • 4 years, 2 months.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/16 • 4 years, 2 months.
|
6.7%
1/15 • Number of events 1 • 4 years, 2 months.
|
|
Blood and lymphatic system disorders
Anaemia
|
12.5%
2/16 • Number of events 2 • 4 years, 2 months.
|
0.00%
0/15 • 4 years, 2 months.
|
|
Cardiac disorders
Atrial fibrillation
|
12.5%
2/16 • Number of events 2 • 4 years, 2 months.
|
0.00%
0/15 • 4 years, 2 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.2%
1/16 • Number of events 1 • 4 years, 2 months.
|
6.7%
1/15 • Number of events 1 • 4 years, 2 months.
|
|
Infections and infestations
Bone infection
|
6.2%
1/16 • Number of events 1 • 4 years, 2 months.
|
0.00%
0/15 • 4 years, 2 months.
|
|
Infections and infestations
Bronchial infection
|
6.2%
1/16 • Number of events 2 • 4 years, 2 months.
|
0.00%
0/15 • 4 years, 2 months.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/16 • 4 years, 2 months.
|
13.3%
2/15 • Number of events 2 • 4 years, 2 months.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/16 • 4 years, 2 months.
|
6.7%
1/15 • Number of events 1 • 4 years, 2 months.
|
|
Gastrointestinal disorders
Diarrhea
|
12.5%
2/16 • Number of events 2 • 4 years, 2 months.
|
6.7%
1/15 • Number of events 1 • 4 years, 2 months.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/16 • 4 years, 2 months.
|
6.7%
1/15 • Number of events 1 • 4 years, 2 months.
|
|
General disorders
Edema limbs
|
6.2%
1/16 • Number of events 1 • 4 years, 2 months.
|
0.00%
0/15 • 4 years, 2 months.
|
|
Injury, poisoning and procedural complications
Fall
|
12.5%
2/16 • Number of events 2 • 4 years, 2 months.
|
0.00%
0/15 • 4 years, 2 months.
|
|
General disorders
Fatigue
|
0.00%
0/16 • 4 years, 2 months.
|
6.7%
1/15 • Number of events 1 • 4 years, 2 months.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/16 • 4 years, 2 months.
|
6.7%
1/15 • Number of events 1 • 4 years, 2 months.
|
|
General disorders
Fever
|
0.00%
0/16 • 4 years, 2 months.
|
13.3%
2/15 • Number of events 3 • 4 years, 2 months.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
6.2%
1/16 • Number of events 1 • 4 years, 2 months.
|
0.00%
0/15 • 4 years, 2 months.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/16 • 4 years, 2 months.
|
6.7%
1/15 • Number of events 1 • 4 years, 2 months.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/16 • 4 years, 2 months.
|
6.7%
1/15 • Number of events 1 • 4 years, 2 months.
|
|
Vascular disorders
Hypotension
|
6.2%
1/16 • Number of events 1 • 4 years, 2 months.
|
6.7%
1/15 • Number of events 1 • 4 years, 2 months.
|
|
Infections and infestations
Infection
|
0.00%
0/16 • 4 years, 2 months.
|
6.7%
1/15 • Number of events 1 • 4 years, 2 months.
|
|
Infections and infestations
Lung infection
|
6.2%
1/16 • Number of events 1 • 4 years, 2 months.
|
20.0%
3/15 • Number of events 3 • 4 years, 2 months.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/16 • 4 years, 2 months.
|
6.7%
1/15 • Number of events 1 • 4 years, 2 months.
|
|
Infections and infestations
Sepsis
|
12.5%
2/16 • Number of events 2 • 4 years, 2 months.
|
0.00%
0/15 • 4 years, 2 months.
|
|
Infections and infestations
Skin infection
|
6.2%
1/16 • Number of events 1 • 4 years, 2 months.
|
0.00%
0/15 • 4 years, 2 months.
|
|
Nervous system disorders
Stroke
|
0.00%
0/16 • 4 years, 2 months.
|
6.7%
1/15 • Number of events 1 • 4 years, 2 months.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/16 • 4 years, 2 months.
|
6.7%
1/15 • Number of events 1 • 4 years, 2 months.
|
|
Nervous system disorders
Syncope
|
6.2%
1/16 • Number of events 1 • 4 years, 2 months.
|
0.00%
0/15 • 4 years, 2 months.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/16 • 4 years, 2 months.
|
6.7%
1/15 • Number of events 1 • 4 years, 2 months.
|
|
Nervous system disorders
Transient ischemic attacks
|
6.2%
1/16 • Number of events 1 • 4 years, 2 months.
|
0.00%
0/15 • 4 years, 2 months.
|
|
Infections and infestations
Upper respiratory infection
|
12.5%
2/16 • Number of events 2 • 4 years, 2 months.
|
0.00%
0/15 • 4 years, 2 months.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/16 • 4 years, 2 months.
|
6.7%
1/15 • Number of events 1 • 4 years, 2 months.
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
1/16 • Number of events 1 • 4 years, 2 months.
|
6.7%
1/15 • Number of events 1 • 4 years, 2 months.
|
Other adverse events
| Measure |
Arm A (BBD)
n=16 participants at risk
Bortezomib, Bendamustine and Dexamethasone
Bortezomib: 1.3 mg/m2 subcutaneously\* days 1, 4, 8 and 11 of each cycle. Number of cycles: Four 21 day cycles (participants not suitable for ASCT (autologous stem cell transplant) will continue up to 6 cycles on the treatment regimen to which they were randomised).
\*intravenous infusion available in case of patient intolerance to subcutaneous bortezomib
Bendamustine: 60 mg/m2 i.v. days 1 and 8 of each cycle. Four 21 day cycles (participants not suitable for ASCT will continue up to 6 cycles on the treatment regimen to which they were randomised)
Dexamethasone: 40mg orally days 1-2, 4-5, 8-9 and 11-12 of each cycle
|
Arm B (BTD)
n=15 participants at risk
Thalidomide, Bendamustine and Dexamethasone
Thalidomide: 100 mg daily orally, preferably at night, days 1-21 of each cycle. Four 21 day cycles (participants not suitable for ASCT will continue up to 6 cycles on the treatment regimen to which they were randomised)
Bendamustine: 60 mg/m2 i.v. days 1 and 8 of each cycle. Four 21 day cycles (participants not suitable for ASCT will continue up to 6 cycles on the treatment regimen to which they were randomised)
Dexamethasone: 40mg orally days 1-2, 4-5, 8-9 and 11-12 of each cycle
|
|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/16 • 4 years, 2 months.
|
6.7%
1/15 • Number of events 1 • 4 years, 2 months.
|
|
Investigations
Alkaline Phosphatase Increased
|
0.00%
0/16 • 4 years, 2 months.
|
6.7%
1/15 • Number of events 1 • 4 years, 2 months.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/16 • 4 years, 2 months.
|
6.7%
1/15 • Number of events 1 • 4 years, 2 months.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/16 • 4 years, 2 months.
|
13.3%
2/15 • Number of events 2 • 4 years, 2 months.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/16 • 4 years, 2 months.
|
6.7%
1/15 • Number of events 4 • 4 years, 2 months.
|
|
Metabolism and nutrition disorders
Anorexia
|
6.2%
1/16 • Number of events 1 • 4 years, 2 months.
|
0.00%
0/15 • 4 years, 2 months.
|
|
Psychiatric disorders
Anxiety
|
6.2%
1/16 • Number of events 1 • 4 years, 2 months.
|
0.00%
0/15 • 4 years, 2 months.
|
|
Infections and infestations
Bone infection
|
6.2%
1/16 • Number of events 1 • 4 years, 2 months.
|
0.00%
0/15 • 4 years, 2 months.
|
|
Infections and infestations
Bronchial Infection
|
6.2%
1/16 • Number of events 1 • 4 years, 2 months.
|
0.00%
0/15 • 4 years, 2 months.
|
|
Infections and infestations
Catheter related infection
|
6.2%
1/16 • Number of events 1 • 4 years, 2 months.
|
0.00%
0/15 • 4 years, 2 months.
|
|
Injury, poisoning and procedural complications
Fall
|
6.2%
1/16 • Number of events 1 • 4 years, 2 months.
|
6.7%
1/15 • Number of events 1 • 4 years, 2 months.
|
|
General disorders
Fever
|
6.2%
1/16 • Number of events 1 • 4 years, 2 months.
|
6.7%
1/15 • Number of events 1 • 4 years, 2 months.
|
|
Investigations
Weight Loss
|
6.2%
1/16 • Number of events 1 • 4 years, 2 months.
|
6.7%
1/15 • Number of events 1 • 4 years, 2 months.
|
|
Blood and lymphatic system disorders
Anemia
|
6.2%
1/16 • Number of events 1 • 4 years, 2 months.
|
20.0%
3/15 • Number of events 4 • 4 years, 2 months.
|
|
Nervous system disorders
Tremor
|
6.2%
1/16 • Number of events 1 • 4 years, 2 months.
|
20.0%
3/15 • Number of events 4 • 4 years, 2 months.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
6.2%
1/16 • Number of events 1 • 4 years, 2 months.
|
20.0%
3/15 • Number of events 8 • 4 years, 2 months.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
6.2%
1/16 • Number of events 1 • 4 years, 2 months.
|
0.00%
0/15 • 4 years, 2 months.
|
|
Eye disorders
Conjunctivtis
|
6.2%
1/16 • Number of events 1 • 4 years, 2 months.
|
0.00%
0/15 • 4 years, 2 months.
|
|
Infections and infestations
Enterocolitis infectious
|
6.2%
1/16 • Number of events 1 • 4 years, 2 months.
|
0.00%
0/15 • 4 years, 2 months.
|
|
Psychiatric disorders
Insomnia
|
6.2%
1/16 • Number of events 1 • 4 years, 2 months.
|
0.00%
0/15 • 4 years, 2 months.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal hemorrhage
|
6.2%
1/16 • Number of events 1 • 4 years, 2 months.
|
0.00%
0/15 • 4 years, 2 months.
|
|
Infections and infestations
Mucosal infection
|
6.2%
1/16 • Number of events 1 • 4 years, 2 months.
|
0.00%
0/15 • 4 years, 2 months.
|
|
Gastrointestinal disorders
Mucositis oral
|
6.2%
1/16 • Number of events 1 • 4 years, 2 months.
|
0.00%
0/15 • 4 years, 2 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify: Labial cyst
|
6.2%
1/16 • Number of events 1 • 4 years, 2 months.
|
0.00%
0/15 • 4 years, 2 months.
|
|
Infections and infestations
Papulopustular rash
|
6.2%
1/16 • Number of events 1 • 4 years, 2 months.
|
0.00%
0/15 • 4 years, 2 months.
|
|
Eye disorders
Blurred vision
|
6.2%
1/16 • Number of events 2 • 4 years, 2 months.
|
0.00%
0/15 • 4 years, 2 months.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.2%
1/16 • Number of events 2 • 4 years, 2 months.
|
0.00%
0/15 • 4 years, 2 months.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.2%
1/16 • Number of events 2 • 4 years, 2 months.
|
0.00%
0/15 • 4 years, 2 months.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
6.2%
1/16 • Number of events 2 • 4 years, 2 months.
|
0.00%
0/15 • 4 years, 2 months.
|
|
Nervous system disorders
Syncope
|
6.2%
1/16 • Number of events 2 • 4 years, 2 months.
|
0.00%
0/15 • 4 years, 2 months.
|
|
Nervous system disorders
Dizziness
|
12.5%
2/16 • Number of events 2 • 4 years, 2 months.
|
6.7%
1/15 • Number of events 1 • 4 years, 2 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
12.5%
2/16 • Number of events 2 • 4 years, 2 months.
|
6.7%
1/15 • Number of events 1 • 4 years, 2 months.
|
|
Infections and infestations
Skin infection
|
12.5%
2/16 • Number of events 2 • 4 years, 2 months.
|
6.7%
1/15 • Number of events 1 • 4 years, 2 months.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
12.5%
2/16 • Number of events 2 • 4 years, 2 months.
|
6.7%
1/15 • Number of events 1 • 4 years, 2 months.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
12.5%
2/16 • Number of events 2 • 4 years, 2 months.
|
13.3%
2/15 • Number of events 5 • 4 years, 2 months.
|
|
Nervous system disorders
Paresthesia
|
12.5%
2/16 • Number of events 2 • 4 years, 2 months.
|
20.0%
3/15 • Number of events 3 • 4 years, 2 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
2/16 • Number of events 3 • 4 years, 2 months.
|
0.00%
0/15 • 4 years, 2 months.
|
|
Gastrointestinal disorders
Vomiting
|
18.8%
3/16 • Number of events 3 • 4 years, 2 months.
|
6.7%
1/15 • Number of events 1 • 4 years, 2 months.
|
|
Investigations
Neutrophil count decreased
|
18.8%
3/16 • Number of events 3 • 4 years, 2 months.
|
13.3%
2/15 • Number of events 2 • 4 years, 2 months.
|
|
General disorders
Edema limbs
|
25.0%
4/16 • Number of events 4 • 4 years, 2 months.
|
20.0%
3/15 • Number of events 3 • 4 years, 2 months.
|
|
General disorders
Fatigue
|
25.0%
4/16 • Number of events 4 • 4 years, 2 months.
|
33.3%
5/15 • Number of events 9 • 4 years, 2 months.
|
|
Infections and infestations
Lung infection
|
12.5%
2/16 • Number of events 5 • 4 years, 2 months.
|
20.0%
3/15 • Number of events 5 • 4 years, 2 months.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
4/16 • Number of events 5 • 4 years, 2 months.
|
6.7%
1/15 • Number of events 1 • 4 years, 2 months.
|
|
Gastrointestinal disorders
Diarrhea
|
18.8%
3/16 • Number of events 6 • 4 years, 2 months.
|
13.3%
2/15 • Number of events 3 • 4 years, 2 months.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
4/16 • Number of events 11 • 4 years, 2 months.
|
20.0%
3/15 • Number of events 3 • 4 years, 2 months.
|
|
Renal and urinary disorders
Chronic Kidney Disease
|
0.00%
0/16 • 4 years, 2 months.
|
6.7%
1/15 • Number of events 1 • 4 years, 2 months.
|
|
Investigations
Creatinine increased
|
0.00%
0/16 • 4 years, 2 months.
|
6.7%
1/15 • Number of events 1 • 4 years, 2 months.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/16 • 4 years, 2 months.
|
6.7%
1/15 • Number of events 1 • 4 years, 2 months.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/16 • 4 years, 2 months.
|
6.7%
1/15 • Number of events 1 • 4 years, 2 months.
|
|
Eye disorders
Eye disorders - Other, specify: visual disturbance?
|
0.00%
0/16 • 4 years, 2 months.
|
6.7%
1/15 • Number of events 1 • 4 years, 2 months.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/16 • 4 years, 2 months.
|
6.7%
1/15 • Number of events 1 • 4 years, 2 months.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/16 • 4 years, 2 months.
|
6.7%
1/15 • Number of events 1 • 4 years, 2 months.
|
|
Vascular disorders
Hypertension
|
0.00%
0/16 • 4 years, 2 months.
|
6.7%
1/15 • Number of events 1 • 4 years, 2 months.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/16 • 4 years, 2 months.
|
6.7%
1/15 • Number of events 1 • 4 years, 2 months.
|
|
Vascular disorders
Hypotension
|
0.00%
0/16 • 4 years, 2 months.
|
6.7%
1/15 • Number of events 1 • 4 years, 2 months.
|
|
Infections and infestations
Infections and infestations - Other, specify: infection (unknown source)
|
0.00%
0/16 • 4 years, 2 months.
|
6.7%
1/15 • Number of events 1 • 4 years, 2 months.
|
|
General disorders
Infusion Site Extravasation
|
0.00%
0/16 • 4 years, 2 months.
|
6.7%
1/15 • Number of events 1 • 4 years, 2 months.
|
|
Cardiac disorders
Left Ventricular systolic dysfunction
|
0.00%
0/16 • 4 years, 2 months.
|
6.7%
1/15 • Number of events 1 • 4 years, 2 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
0.00%
0/16 • 4 years, 2 months.
|
6.7%
1/15 • Number of events 1 • 4 years, 2 months.
|
|
Gastrointestinal disorders
Oral Dysesthesia
|
0.00%
0/16 • 4 years, 2 months.
|
6.7%
1/15 • Number of events 1 • 4 years, 2 months.
|
|
General disorders
Pain
|
0.00%
0/16 • 4 years, 2 months.
|
6.7%
1/15 • Number of events 1 • 4 years, 2 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/16 • 4 years, 2 months.
|
6.7%
1/15 • Number of events 1 • 4 years, 2 months.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/16 • 4 years, 2 months.
|
6.7%
1/15 • Number of events 1 • 4 years, 2 months.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/16 • 4 years, 2 months.
|
6.7%
1/15 • Number of events 1 • 4 years, 2 months.
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
0.00%
0/16 • 4 years, 2 months.
|
6.7%
1/15 • Number of events 1 • 4 years, 2 months.
|
|
Vascular disorders
Superficial thrombophlebitis
|
0.00%
0/16 • 4 years, 2 months.
|
6.7%
1/15 • Number of events 1 • 4 years, 2 months.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/16 • 4 years, 2 months.
|
6.7%
1/15 • Number of events 1 • 4 years, 2 months.
|
|
Skin and subcutaneous tissue disorders
Erythroderma
|
0.00%
0/16 • 4 years, 2 months.
|
6.7%
1/15 • Number of events 2 • 4 years, 2 months.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantae erythrodysesthesia syndrome
|
0.00%
0/16 • 4 years, 2 months.
|
6.7%
1/15 • Number of events 2 • 4 years, 2 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/16 • 4 years, 2 months.
|
13.3%
2/15 • Number of events 2 • 4 years, 2 months.
|
|
Infections and infestations
Infections and infestations - Other, specify: (Oral) thrush
|
0.00%
0/16 • 4 years, 2 months.
|
13.3%
2/15 • Number of events 2 • 4 years, 2 months.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/16 • 4 years, 2 months.
|
13.3%
2/15 • Number of events 2 • 4 years, 2 months.
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/16 • 4 years, 2 months.
|
13.3%
2/15 • Number of events 2 • 4 years, 2 months.
|
|
Investigations
White blood cell decreased
|
0.00%
0/16 • 4 years, 2 months.
|
13.3%
2/15 • Number of events 2 • 4 years, 2 months.
|
Additional Information
Richard Brouwer
Oxford University Hospitals NHS Foundation Trust
Phone: 441865226950
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place