Myeloma and renal impairment MedDRA version: 16.1 Level: LLT Classification code 10024460 Term: Light chain disease myeloma associated System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Thalidomide Celgene™
Product Name: Thalidomide celgene
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Thalidomide
CAS Number: 841-67-8
Concentration unit: mg milligram(s)
Concentr
Sponsors
Oxford University Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives is to compare the amount of serum free light chain circulating in the body, the rate of renal recovery and overall survival in response to two cycles of therapy with either thalidomide or bortezomib in patients presenting with myeloma and renal failure. The co-primary objective is to determine if the response to treatment of the myeloma tumour burden is mirrored in the renal response at the end of cycle 4.;Secondary Objective: The secondary objectives are as follows: - Assess whether it is possible to predict how well a participant will respond to either treatment after only two cycles of treatment . - Compare change in participant's kidney function at the end of cycles 2 and 4 between the two groups. - Compare participant survival from date of randomisation to end the of treatment (maximum 18 weeks + end of trial visit) - Compare how well participants tolerate treatments between the two arms of the trial - Assess participants Quality of life (EQ-5D)before, during and following treatment ;Primary end point(s): Proportion of participants with response defined as >50% reduction in sFLC after receiving two cycles of therapy (0- 6 weeks from entry) Renal response at end of 4 cycles of therapy. Modified IMWG Uniform Criteria Of Response and Progression 1998, 2006, 2011 ;Timepoint(s) of evaluation of this end point: Response at 6 weeks and 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary objectives are as follows: - Assess whether early response can predict individual patient responses at 1, 2, 3, 5, 6, 8, 9, 11 and 12 weeks - Compare change in renal function at the end of cycles 2 and 4 - Assess haematological and non-haematological toxicity in both treatment arms - Compare survival from date of randomisation to end of treatment (12 weeks) - Quality of life (EQ-5D) ;Timepoint(s) of evaluation of this end point: responses at 1, 2, 3, 5, 6, 8, 9, 11 and 12 weeks | — |
Countries
United Kingdom
Contacts
Public ContactDr Karthik Ramasamy
Oxford University Hospitals NHS Trust
Outcome results
None listed