enalidomide and Dexamethasone for treatment of patients with acute myeloma (light chain)-induced renal failure

Conditions: 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.
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2008-006497-15-AT

Lead Sponsor: Wilhelminen Krebsforschung GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 50

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 (GFR<50ml/min serum creatinine minimum 2.0 mg/dL) and with further workup revealing light chain induced renal injury with MM as underlying cause.
b) Patients with previously established MM and normal renal function (GFR at least 60ml/min and serum creatinine =1.2mg/dl) with progressive disease and acute (within 6 weeks) light chain induced renal failure (GFR<50ml/min and creatinine = 2.0 mg/dL).
4. All previous medical anti-myeloma therapy (excluding corticosteroids) must have been discontinued at least 3 weeks prior to treatment in this study.
5. Able to adhere to the study visit schedule and other protocol requirements.
6. Measurable serum or urine paraprotein
7. Laboratory test results within these ranges:
•Glomerular filtration rate < 50ml/min
•Serum creatinine = 2.0mg/dL
•Absolute leukocyte count minimum 1.5 x 109/L
•Platelet count minimum 75 G/L if bone marrow plasma cell infiltration (BMPC) is >50% or at least 30 G/L if BMPC infiltration is <50%.
•Total bilirubin not more than 1.5 mg/dL
•AST (SGOT) and ALT (SGPT) not more than 2,5 x ULN
8. Females of childbearing potential (FCBP) must use one effective method of contraception for 4 weeks before therapy, during therapy, and until 4 weeks after lenalidomide therapy and even in case of dose interruption unless the patient commits to absolute and continuous abstinence confirmed on a monthly basis. If not established on effective contraception, the patient must be referred to an appropriately trained health care professional for contraceptive advice in order that contraception can be initiated.
10. Disease free of prior malignancies for at least 3 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma in situ” of the cervix or breast
11. Agree to take low molecular weight heparin as prophylactic anticoagulation.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the response rate (CR, VGPR, PR, MR, SD, and PD);Secondary Objective: To determine the renal response rate<br>To determine the relation between category of myeloma response and improvement in GFR<br>To determine the proportion of patients spared hemodialysis<br>To determine PFS, EFS, OS<br>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)<br>;Timepoint(s) of evaluation of this end point: every cycle / day 1, EOT, FU

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): PFS, EFS, OS, safety;Timepoint(s) of evaluation of this end point: every cycle / day 1, EOT, FU

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