A Phase 2 interventional study of Bortezomib and Thalidomide in Multiple Myeloma and Chronic Kidney Disease, sponsored by Oxford University Hospitals NHS Trust. Completed at 9 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-27.
Sponsored by Oxford University Hospitals NHS Trust · Phase 2, Interventional, and Treatment
The purpose of this study is to compare the effectiveness of bortezomib versus thalidomide in reducing free light chains in the blood of myeloma patients. In addition participants will receive bendamustine (chemotherapy) and dexamethasone (steroids), which increase the effectiveness of both bortezomib and thalidomide. The trial will also study whether an earlier reduction of free light chains increases the chances of the kidneys recovering.
Renal impairment is a life threatening condition of myeloma. 20-25% of patients will present at diagnosis with renal dysfunction. Outcome is poor due to high early mortality, with 28% of newly diagnosed myeloma patients in myeloma trials with renal failure not surviving beyond 100 days, compared with 10% overall.
This study aims to establish:
Participants will be stratified by age and chronic kidney disease (CKD) stage to receive either bortezomib, bendamustine and dexamethasone (BBD) or thalidomide, bendamustine and dexamethasone (BTD).
3,712 studies on the registry are indexed under Multiple Myeloma; 752 are open to participants now.
This study's enrollment of 31 is below the median of 41 across 2,965 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Oxford University Hospitals NHS Trust is the lead sponsor of 94 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
Bortezomib, Bendamustine and Dexamethasone
Drug: Bortezomib · Drug: Bendamustine · Drug: Dexamethasone
Thalidomide, Bendamustine and Dexamethasone
Drug: Thalidomide · Drug: Bendamustine · Drug: Dexamethasone
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
Also known as: Velcade
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)
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)
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
Time frame: End of week 6 (after receiving two cycles of therapy)
Number of Participants With Different Renal Responses to Treatment
Time frame: End of week 12 (after receiving 4 cycles of therapy)
Haematological and Non-haematological Toxicity in Both Treatment Arms
Time frame: End of weeks 3, 6, 9, 12 (after receiving 4 cycles of therapy), 30 days after final treatment and 12 months after randomisation
Overall Survival
Time frame: 1 month post end of treatment and 1 year post randomisation
Renal Response After Two Cycles of Trial Treatment
Time frame: End of 2nd treatment cycle, week 6
Quality of Life Measured by the EQ-5D-3L Questionnaire at Baseline and 1 Month Follow up
The 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.
Time frame: Baseline and 1 month follow up
| Milestone | Arm A (BBD) | Arm B (BTD) |
|---|---|---|
| Started | 16 | 15 |
| Completed | 14 | 12 |
| Not completed | 2 | 3 |
| Participants | Arm A (BBD) | Arm B (BTD) |
|---|---|---|
| Number of Participants With >50% Reduction From Baseline in Serum Free Light Chain | 13 | 3 |
| Participants | Arm A (BBD) | Arm B (BTD) |
|---|---|---|
| Complete/partial response | 5 | 1 |
| Minor response | 3 | 7 |
| No response | 3 | 1 |
| Not evaluable | 5 | 6 |
| Events | Arm A (BBD) | Arm B (BTD) |
|---|---|---|
| Serious adverse events | 2 | 0 |
| Adverse events | 3 | 6 |
| Participants | Arm A (BBD) | Arm B (BTD) |
|---|---|---|
| Overall Survival | 9 | 13 |
| Participants | Arm A (BBD) | Arm B (BTD) |
|---|---|---|
| Partial response | 2 | 0 |
| Minor response | 9 | 7 |
| No repsonse | 4 | 6 |
The 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.
| Units on a scale | Arm A (BBD) | Arm B (BTD) |
|---|---|---|
| Baseline | 0.72 ± 0.15 | 0.69 ± 0.35 |
| 1 month FU | 0.69 ± 0.19 | 0.80 ± 0.28 |
Collected over 4 years, 2 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm A (BBD) | 7/16 (43.8%) | 11/16 (68.8%) | 15/16 (93.8%) |
| Arm B (BTD) | 2/15 (13.3%) | 9/15 (60%) | 11/15 (73.3%) |
| Event | Arm A (BBD) | Arm B (BTD) |
|---|---|---|
| Lung infectionInfections and infestations | 1/16 | 3/15 |
| Chronic kidney diseaseRenal and urinary disorders | 0/16 | 2/15 |
| FeverGeneral disorders | 0/16 | 2/15 |
| AnaemiaBlood and lymphatic system disorders | 2/16 | 0/15 |
| Atrial fibrillationCardiac disorders | 2/16 | 0/15 |
| DiarrheaGastrointestinal disorders | 2/16 | 1/15 |
| FallInjury, poisoning and procedural complications | 2/16 | 0/15 |
| SepsisInfections and infestations | 2/16 | 0/15 |
| Upper respiratory infectionInfections and infestations | 2/16 | 0/15 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 0/16 | 1/15 |
| Event | Arm A (BBD) | Arm B (BTD) |
|---|---|---|
| FatigueGeneral disorders | 4/16 | 5/15 |
| Edema limbsGeneral disorders | 4/16 | 3/15 |
| NauseaGastrointestinal disorders | 4/16 | 1/15 |
| ConstipationGastrointestinal disorders | 4/16 | 3/15 |
| AnemiaBlood and lymphatic system disorders | 1/16 | 3/15 |
| TremorNervous system disorders | 1/16 | 3/15 |
| Rash maculo-papularSkin and subcutaneous tissue disorders | 1/16 | 3/15 |
| ParesthesiaNervous system disorders | 2/16 | 3/15 |
| Lung infectionInfections and infestations | 2/16 | 3/15 |
| VomitingGastrointestinal disorders | 3/16 | 1/15 |
| Age, Customized(Participants) | Arm A (BBD) | Arm B (BTD) | Total |
|---|---|---|---|
| ≤70 years | 8 | 8 | 16 |
| >70 years | 8 | 7 | 15 |
| Sex: Female, Male(Participants) | Arm A (BBD) | Arm B (BTD) | Total |
|---|---|---|---|
| Female | 8 | 6 | 14 |
| Male | 8 | 9 | 17 |
| Race and Ethnicity Not Collected(Participants) | Arm A (BBD) | Arm B (BTD) | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Arm A (BBD) | Arm B (BTD) | Total |
|---|---|---|---|
| United Kingdom | 16 | 15 | 31 |
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The record gives a start of Nov 2014, a primary completion of Apr 2020 and a completion of Apr 2020. It does not say whether these dates are actual or estimated.
Results were first posted in Jan 2022, 1 year 9 months after primary completion.
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Studies of the drugs tested here: Bortezomib · Thalidomide
Oxford University Hospitals NHS Trust