OPTIMAL: OPTimising renal outcome in Myeloma renal failure

Not Applicable

Completed

• Conditions: Topic: Cancer; Subtopic: Haematological Oncology; Disease: Myeloma; Cancer

• Registration Number: ISRCTN32505664
• Lead Sponsor: Oxford University Hospitals NHS Foundation Trust

Brief Summary

2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36446771/ results (added 12/12/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-06-19
• Study Completion: 2020-06-01
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

1. Patients attending NHS haemato-oncology centres
2. Patients with newly diagnosed symptomatic myeloma and renal failure
3. Patients willing and able to give written informed consent
4. Chronic kidney disease stage 4 or 5
5. GFR <30 ml/min
6. A number of patients with newly diagnosed myeloma and renal failure will have a pre-existing medical condition (hypertension, diabetes etc) causing renal damage. Where there is a medical condition (eg. hypertension, diabetes) which may cause renal damage, there must have been a further decline (=15 ml/min) between previous steady state and the study screening
7. Women of childbearing potential (WCBP) and male participants whose partner is a WCBP must be prepared to use contraception in accordance with (and consent) to the Celgene-approved process for thalidomide and lenalidomide Risk Management and Pregnancy Prevention Programme
8. WCBP must have a negative pregnancy test performed by a healthcare professional in accordance with the Celgene-approved process for thalidomide and lenalidomide Risk Management and Pregnancy Prevention
9. Free of prior malignancies for = 2 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, localised prostate cancer or carcinoma 'in situ' of the cervix or breast
10. In the Investigator's opinion, is able and willing to comply with all trial requirements
11. Willing to allow his or her GP and consultant, if appropriate, to be notified of participation in the trial

Exclusion Criteria

1. Female patient who is pregnant, lactating or planning pregnancy during the course of the trial or the female partner of a male participant planning a pregnancy during the course of the trial
2. Age <18 years
3. Known allergy to investigational drugs
4. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial
5. Any of the following laboratory abnormalities:
5.1. Absolute neutrophil count (ANC) <1.0 x 10(9)/L
5.2. Platelet count <75 x 10(9)/L
5.3. Serum SGOT/AST or SGPT/ALT >3 x upper limit of normal
6. Use of any standard/experimental anti-myeloma drug therapy 14 days prior to trial entry
7. CKD <4
8. Intention to use a physical method of serum free light chain removal such as plasma exchange or high cut-off dialysis
9. Grade 2 neuropathy (NCICTCAE v 4.0) or more will preclude use of thalidomide and bortezomib
10. Participants who have participated in another research trial involving an investigational product in the past 12 weeks.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Response defined as >50% reduction (from baseline) in sFLC week 6 (end of cycle 2)<br><br> Added 16/02/2017:<br> 1. Serum free light chain response is measured as the proportion of participants with response defined as >50% reduction (from baseline) in sFLC week 6 (end of cycle 2).<br> 2. Myeloma response is measured by the renal response (Modified IMWG Uniform Criteria Of Response and Progression) at the end of 4 cycles of therapy<br>

Secondary Outcome Measures

Name	Time	Method
<br> Renal response at end of four cycles of therapy.<br><br> Added 16/02/2017:<br> 1. Overall response and correlation with monoclonal protein the urine is measured by the sFLC response at week 1, 2, 3, 4, 5, 6, 9 and 12<br> 2. Haematological and non-hameatological toxicity in both arms is preasured by haematological responses adverse Events (NCI CTCAE v4.0) criteria<br> 3. Survival at 1 month post end of treatment and 12 months post randomisation<br> 4. change in renal function between the two treatment regimens is assessed by the renal response (defined by the IMWG renal response criteria) at the end of cycle 2 and cycle 4<br> 5. Treatment effects on other patient reported outcomes is measured by the EQ-5D-3L Quality of life questionnaire at baseline, start of each treatment cycle and at 1 and 12 months post follow-up<br>