There are two patient groups to be included into the study: 1) Patients with previously unknown MM and acute light chain induced renal failure 2) Patients with previously diagnosed MM, normal or near normal renal function (GFR minimum 60ml/min and serum creatinine =1.2mg/dl) within the previous 6 weeks before onset of acute light chain induced deterioration of renal function to GFR <50ml/min and serum creatinine not less than 2mg/dL.
Conditions
Interventions
Trade Name: Revlimid 25mg, hard capsules
Product Name: Lenalidomide
Product Code: CC-5013
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: LENALIDOMIDE
CAS Number: 191732-72-6
Concentration uni
Sponsors
Wilhelminen Krebsforschung GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Understand and voluntarily sign an informed consent form. 2. Age at least 18 years at the time of signing the informed consent form. 3. MM (all stages) with acute light chain induced renal impairment a) Patients with previously unknown MM and acute light chain induced renal failure (GFR50% or at least 30 G/L if BMPC infiltration is =65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: 1. Acute renal failure due to other causes than light-chain induced nephropathy such as NSAIRS, antibiotics, or other nephrotoxic drugs, or others. 2. Acute renal failure due to hypercalcemia only, without excretion of nephrotoxic light chains. 3. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. 4. Any prior use of lenalidomide 5. Any anti-myeloma therapy within 3 weeks before day 1 of first cycle, with the exception of dexamethasone 40mg (maximum dose 160mg) or corticosteroid equivalent. 6. Any other experimental drug or therapy within 3 weeks of baseline 7. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study. 8. The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs. 9. Known positive for HIV or infectious hepatitis, type A, B or C or evidence of any severe active or chronic infection. 10. Clinical significant heart disease (NYHA status>2) 11. Pregnant or breast feeding females 12. Anamnesis of thromboembolic complications, such as stroke, myocardial infarction and pulmonary embolism
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the response rate (CR, VGPR, PR, MR, SD, and PD);Secondary Objective: To determine the renal response rate To determine the relation between category of myeloma response and improvement in GFR To determine the proportion of patients spared hemodialysis To determine PFS, EFS, OS To evaluate toxicity, according to the NCCN toxicity scale;Primary end point(s): To determine the response rate (CR, VGPR, PR, MR, SD, and PD) ;Timepoint(s) of evaluation of this end point: every cycle / day 1, EOT, FU | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): PFS, EFS, OS, safety;Timepoint(s) of evaluation of this end point: every cycle / day 1, EOT, FU | — |
Countries
Austria, Czech Republic, Germany
Contacts
Public ContactClinical Trial Unit
Wilhelminen Krebsforschung GmbH
Outcome results
None listed