Phase 2
N=31
Optimising Renal Outcome in Myeloma Renal Failure
Multiple Myeloma · Chronic Kidney Disease
Bottom Line
View on ClinicalTrials.gov: NCT02424851 ↗Enrolled (actual)
31
Serious AEs
64.5%
Results posted
Jan 2022
Primary outcome: Primary: Number of Participants With >50% Reduction From Baseline in Serum Free Light Chain — 13; 3 Participants — p=0.006
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Bortezomib (Drug); Thalidomide (Drug); Bendamustine (Drug); Dexamethasone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Oxford University Hospitals NHS Trust
- Primary completion
- Apr 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With >50% Reduction From Baseline in Serum Free Light Chain |
13; 3 | 0.006 sig |
| PRIMARY Number of Participants With Different Renal Responses to Treatment |
5; 1; 3; 7; 3; 1 | 0.02 sig |
| SECONDARY Haematological and Non-haematological Toxicity in Both Treatment Arms |
2; 0; 3; 6 | =0.48 |
| SECONDARY Overall Survival |
9; 13 | = 0.31 |
| SECONDARY Renal Response After Two Cycles of Trial Treatment |
2; 0; 9; 7; 4; 6 | =0.45 |
| SECONDARY Quality of Life Measured by the EQ-5D-3L Questionnaire at Baseline and 1 Month Follow up |
0.72; 0.69; 0.69; 0.80 | 0.33 |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Participant is willing and able to give informed consent for participation in the trial.
- Patients attending NHS (National Health Service) Haemato-oncology centres.
- Patients with newly diagnosed symptomatic myeloma.
- Glomerular Filtration Rate (GFR) 3 x upper limit of normal.
- Use of any standard/experimental anti-myeloma drug therapy excluding dexamethasone 14 days prior to trial entry.
- CKD stages < 4.
- Intention to use a physical method of serum free light chain removal such as plasma exchange or high cut off dialysis.
- Grade 2 neuropathy or more (National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v 4.0) will preclude use of thalidomide and bortezomib.
- Participants who have participated in another research trial involving an investigational product in the past 12 weeks.
- Contraindicated to receive either one of the study drugs, thalidomide, bortezomib, bendamustine based on the respective summary of product characteristics.
Data sourced from ClinicalTrials.gov (NCT02424851). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.