E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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.
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To determine the response rate (CR, VGPR, PR, MR, SD, and PD) |
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E.2.2 | Secondary objectives of the trial |
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 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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
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E.5 End points |
E.5.1 | Primary end point(s) |
To determine the response rate (CR, VGPR, PR, MR, SD, and PD)
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Information not present in EudraCT |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Information not present in EudraCT |
E.8.5.1 | Number of sites anticipated in the EEA | 14 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 5 |