OPTIMAL: Optimising Renal Outcome in Myeloma renal failure

Phase 1

• Conditions: Myeloma and renal impairment; MedDRA version: 16.1Level: LLTClassification code 10024460Term: Light chain disease myeloma associatedSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-003947-31-GB
• Lead Sponsor: Oxford University Hospitals NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-01-17
• Last Update Posted: 20 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

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 <30mls/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 (=15mls/min) between previous steady state and the study screening
7.Female 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. Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test within 10-14 days and again within 24 hours of starting study drug.
9. Free of prior malignancies for = 2 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, 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
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

1. Female patient who is pregnance, 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 serious medical condition 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:
- Absolute neutrophil count (ANC) <1.0 x 10(9)/L
- Platelet count <75 x 10(9)/L
- Serum SGOT/AST or SGPT/ALT >3.0 x upper limit of normal
5. Use of any standard/experimental anti-myeloma drug therapy 14 days prior to trial entry
6. CKD <4
7. Intention to use a physical method of serum free light chain removal such as plasma exchange or high cut off dialysis
8. Grade 2 neuropathy or more will preclude use of thalidomide and bortezomib
9. Participants who have participated in another research trial involving an investigational product in the past 12 weeks.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified