Trial · NCT02424851
Optimising Renal Outcome in Myeloma Renal Failure
NCT02424851, Phase 2, Completed, Oxford University Hospitals NHS Trust; results first posted 2022-01-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Optimising Renal Outcome in Myeloma Renal Failure. Trials, record NCT02424851. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02424851
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Optimising Renal Outcome in Myeloma Renal Failure
- NCT number
- NCT02424851
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 31 participants, actual
- Lead sponsor
- Oxford University Hospitals NHS Trust
- Conditions
- Multiple Myeloma, Chronic Kidney Disease
- Interventions
- Bortezomib, Thalidomide, Bendamustine, Dexamethasone
- First posted
- 2015-04-23
- Last updated
- 2022-01-27
- Other registries' IDs
- eudract:2012-003947-31
- Results first posted
- 2022-01-27
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With >50% Reduction From Baseline in Serum Free Light Chain | End of week 6 (after receiving two cycles of therapy) | |
| Primary | 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 | |
| Secondary | Overall Survival | 1 month post end of treatment and 1 year post randomisation | |
| Secondary | Renal Response After Two Cycles of Trial Treatment | End of 2nd treatment cycle, week 6 | |
| Secondary | Quality of Life Measured by the EQ-5D-3L Questionnaire at Baseline and 1 Month Follow up | 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. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With >50% Reduction From Baseline in Serum Free Light Chain | End of week 6 (after receiving two cycles of therapy) | 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. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Different Renal Responses to Treatment | End of week 12 (after receiving 4 cycles of therapy) | 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. | Participants | COUNT_OF_PARTICIPANTS |
| 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 | Events | NUMBER | |
| SECONDARY | Overall Survival | 1 month post end of treatment and 1 year post randomisation | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Renal Response After Two Cycles of Trial Treatment | End of 2nd treatment cycle, week 6 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Quality of Life Measured by the EQ-5D-3L Questionnaire at Baseline and 1 Month Follow up | Baseline and 1 month follow up | Units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With >50% Reduction From Baseline in Serum Free Light Chain | Arm A (BBD) | 13 | Participants | ||
| Number of Participants With >50% Reduction From Baseline in Serum Free Light Chain | Arm B (BTD) | 3 | Participants | ||
| Number of Participants With Different Renal Responses to Treatment | Arm A (BBD) | Complete/partial response | 5 | Participants | |
| Number of Participants With Different Renal Responses to Treatment | Arm B (BTD) | Complete/partial response | 1 | Participants | |
| Number of Participants With Different Renal Responses to Treatment | Arm A (BBD) | Minor response | 3 | Participants | |
| Number of Participants With Different Renal Responses to Treatment | Arm B (BTD) | Minor response | 7 | Participants | |
| Number of Participants With Different Renal Responses to Treatment | Arm A (BBD) | No response | 3 | Participants | |
| Number of Participants With Different Renal Responses to Treatment | Arm B (BTD) | No response | 1 | Participants | |
| Number of Participants With Different Renal Responses to Treatment | Arm A (BBD) | Not evaluable | 5 | Participants | |
| Number of Participants With Different Renal Responses to Treatment | Arm B (BTD) | Not evaluable | 6 | Participants |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A (BBD) | 16 | |
| Overall Study | STARTED | Arm B (BTD) | 15 | |
| Overall Study | COMPLETED | Arm A (BBD) | 14 | |
| Overall Study | COMPLETED | Arm B (BTD) | 12 | |
| Overall Study | NOT COMPLETED | Arm A (BBD) | 2 | |
| Overall Study | NOT COMPLETED | Arm B (BTD) | 3 |
Source ClinicalTrials.gov
Adverse events214
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Alanine aminotransferase increased | Investigations | Arm A (BBD) | 0 | 16 | |
| other | Alanine aminotransferase increased | Investigations | Arm B (BTD) | 1 | 15 | 1 |
| other | Alkaline Phosphatase Increased | Investigations | Arm A (BBD) | 0 | 16 | |
| other | Alkaline Phosphatase Increased | Investigations | Arm B (BTD) | 1 | 15 | 1 |
| other | Arthritis | Musculoskeletal and connective tissue disorders | Arm A (BBD) | 0 | 16 | |
| other | Arthritis | Musculoskeletal and connective tissue disorders | Arm B (BTD) | 1 | 15 | 1 |
| other | Acute Kidney Injury | Renal and urinary disorders | Arm A (BBD) | 0 | 16 | |
| other | Acute Kidney Injury | Renal and urinary disorders | Arm B (BTD) | 2 | 15 | 2 |
| other | Atelectasis | Respiratory, thoracic and mediastinal disorders | Arm A (BBD) | 0 | 16 | |
| other | Atelectasis | Respiratory, thoracic and mediastinal disorders | Arm B (BTD) | 1 | 15 | 4 |
1 to 10 of 214Source ClinicalTrials.gov
See all 214 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A (BBD) | 7 | 16 |
| Total, all-cause mortality | Arm B (BTD) | 2 | 15 |
| Total, other adverse events | Arm A (BBD) | 15 | 16 |
| Total, other adverse events | Arm B (BTD) | 11 | 15 |
| Total, serious adverse events | Arm A (BBD) | 11 | 16 |
| Total, serious adverse events | Arm B (BTD) | 9 | 15 |
Source ClinicalTrials.gov
Papers26
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm A (BBD) vs Arm B (BTD): Number of Participants With >50% Reduction From Baseline in Serum Free Light Chain | Trial comparisons |
| Arm A (BBD) vs Arm B (BTD): deaths from any cause | Trial comparisons |
| Arm A (BBD) vs Arm B (BTD): Overall Survival | Trial comparisons |
| Arm A (BBD) vs Arm B (BTD): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02424851
GET https://conductscience.org/api/trials/v1/NCT02424851/results?page=2