| Trial ID: | L0743 |
| Source ID: | NCT02424851
|
| Associated Drug: |
Bortezomib
|
| Title: |
Optimising Renal Outcome in Myeloma Renal Failure
|
| Acronym: |
OPTIMAL
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT02424851/results
|
| Conditions: |
Multiple Myeloma|Chronic Kidney Disease
|
| Interventions: |
DRUG: Bortezomib|DRUG: Thalidomide|DRUG: Bendamustine|DRUG: Dexamethasone
|
| Outcome Measures: |
Primary: Number of Participants With >50% Reduction From Baseline in Serum Free Light Chain, End of week 6 (after receiving two cycles of therapy)|Number of Participants With Different Renal Responses to Treatment, End of week 12 (after receiving 4 cycles of therapy) | Secondary: Haematological and Non-haematological Toxicity in Both Treatment Arms, 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, 1 month post end of treatment and 1 year post randomisation|Renal Response After Two Cycles of Trial Treatment, 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., Baseline and 1 month follow up
|
| Sponsor/Collaborators: |
Sponsor: Oxford University Hospitals NHS Trust | Collaborators: Janssen-Cilag Ltd.|Bloodwise|University of Warwick|University of Birmingham
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
31
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2014-11
|
| Completion Date: |
2020-04-20
|
| Results First Posted: |
2022-01-27
|
| Last Update Posted: |
2022-01-27
|
| Locations: |
Basingstoke & North Hampshire Hospital, Basingstoke, United Kingdom|Heartlands Hospitals, Birmingham, United Kingdom|Kent & Canterbury Hospital, Canterbury, CT1 3NG, United Kingdom|St Helier Hospital, Epsom, United Kingdom|Royal Liverpool Hospital, Liverpool, United Kingdom|Kings College Hospital, London, United Kingdom|Churchill Hospital, Oxford, OX3 7LE, United Kingdom|Queen Alexandra Hospital, Portsmouth, United Kingdom|Great Western Hospital, Swindon, United Kingdom
|
| URL: |
https://clinicaltrials.gov/show/NCT02424851
|
