Lenalidomide and Dexamethasone for Treatment of Patients With Acute Myeloma (Light Chain)-Induced Renal Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00902915
Recruitment Status : Unknown
Verified November 2013 by Austrian Forum Against Cancer.
Recruitment status was:  Active, not recruiting
First Posted : May 15, 2009
Last Update Posted : November 25, 2013
Information provided by (Responsible Party):
Austrian Forum Against Cancer

Brief Summary:
The purpose of this study is to determine efficacy of lenalidomide and dexamethasone in the treatment of patients with acute Myeloma (light chain)-induced renal failure.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Light Chain Induced Renal Insufficiency Drug: lenalidomide plus dexamethasone Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : May 2009
Estimated Primary Completion Date : May 2014
Estimated Study Completion Date : May 2014

Arm Intervention/treatment
Experimental: Lenalidomide - Dexamethasone Drug: lenalidomide plus dexamethasone
peroral application; lenalidomide dosage according to severity grade of renal failure.

Primary Outcome Measures :
  1. To determine the response rate (CR, VGPR, PR, MR, SD, and PD) 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

Secondary Outcome Measures :
  1. Progression Free Survival, Event Free Survival, Overall Survival; Toxicity, evaluated according to the NCCN toxicity scale (type, frequency, severity, and relationship of adverse events to study treatment).

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Understand and voluntarily sign an informed consent form.
  • Age at least 18 years at the time of signing the informed consent form.
  • MM (all stages) with acute light chain induced renal impairment
  • Patients with previously unknown MM and acute light chain induced renal failure (GFR<50ml/min and serum creatinine minimum 2.0 mg/dL) and with further workup revealing light chain induced renal injury with MM as underlying cause.
  • Patients with previously established MM and normal renal function (GFR ≥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).
  • Disease progression will be documented by one or more of the following criteria:

    • Increase in serum paraprotein by >25%, or increase of 50% of 24 hour urine paraprotein excretion
    • Hypercalcemia
    • Progression of bone lesions
    • Decrease in Hb>2g/dl within 4 weeks (not induced by cytotoxic drugs)
    • Increase in bone marrow plasma cell infiltration by > 25%
  • All previous medical anti-myeloma therapy (excluding corticosteroids) must have been discontinued at least 3 weeks prior to treatment in this study.
  • Able to adhere to the study visit schedule and other protocol requirements.
  • Measurable serum or urine paraprotein
  • Laboratory test results within these ranges:

    • Glomerular filtration rate < 50ml/min
    • Serum creatinine ≥ 2.0mg/dL
    • Absolute leukocyte count ≥ 1.5 x 10G/L
    • Platelet count minimum 75 x 10G/L if bone marrow plasma cell infiltration (BMPC) is ≥50% or minimum 30 x 10G/L if BMPC infiltration is <50%.
    • Total bilirubin minimum 1.5 mg/dL
    • AST (SGOT) and ALT (SGPT) not more than 2,5 x ULN
  • Females of childbearing potential (FCBP) must:

    • Understand that the study medication could have an expected teratogenic risk
    • Agree to use, and be able to comply with, effective contraception without interruption, 4 weeks before starting study drug, throughout study drug therapy (including dose interruptions) and for 4 weeks after the end of study drug therapy, even if she has amenorrhea. This applies unless the subject commits to absolute and continued abstinence confirmed on a monthly basis. The following are effective methods of contraception: Implant, Levonorgestrel-releasing intrauterine system (IUS, Medroxyprogesterone acetate depot), Tubal sterilization, Sexual intercourse with a vasectomised male partner only; vasectomy must be confirmed by two negative semen analyses Ovulation inhibitory progesterone-only pills (i.e., desogestrel)
    • Agree to have a medically supervised pregnancy test with a minimum sensitivity of 25 mIU/ml not more than 3 days before the start of study medication once the subject has been on effective contraception for at least 4 weeks. This requirement also applies to women of childbearing potential who practice complete and continued abstinence.
    • Agree to have a medically supervised pregnancy test every 4 weeks including 4 weeks after the end of study treatment, except in the case of confirmed tubal sterilization. These tests should be performed not more than 3 days before the start of next treatment. This requirement also applies to women of childbearing potential who practice complete and continued abstinence.
  • Male subjects must:

    • Agree to use condoms throughout study drug therapy, during any dose interruption and for 28 days after cessation of study therapy if their partner is of childbearing potential and has no contraception.
    • Agree not to donate semen during study drug therapy and for 28 days after end of study drug therapy.
  • All subjects must agree not to share study medication with another person and to return all unused study drug to the investigator
  • Disease free of prior malignancies for minimum of 3 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast
  • Agree to take low molecular weight heparin as prophylactic anticoagulation.

Exclusion Criteria:

  • Acute renal failure due to other causes than light-chain induced nephropathy such as NSAIRS, antibiotics, or other nephrotoxic drugs, or others.
  • Acute renal failure due to hypercalcemia only, without excretion of nephrotoxic light chains.
  • Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
  • Any prior use of lenalidomide
  • 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.
  • Any other experimental drug or therapy within 3 weeks of baseline
  • 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.
  • The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
  • Known positive for HIV or infectious hepatitis, type A, B or C or evidence of any severe active or chronic infection.
  • Clinical significant heart disease (NYHA status>2)
  • Pregnant or breast feeding females
  • Anamnesis of thromboembolic complications, such as stroke, myocardial infarction and pulmonary embolism

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00902915

LKH Salzburg, 3rd Med. Dept.
Salzburg, Austria, 5020
Austrian Forum Against Cancer; 1st Med. Dept., Center for Hematology and Oncology, Wilhelminenspital, Montleartstrasse 37
Vienna, Austria, 1160
Clinic Wels-Grieskirchen, 4th Internal Dept.
Wels, Austria, 4600
Czech Republic
Faculty Hospital Brno and Faculty of Medicine MU
Brno, Czech Republic, 62500
Charles University Prague
Prague, Czech Republic, 12821
Sponsors and Collaborators
Austrian Forum Against Cancer

Responsible Party: Austrian Forum Against Cancer Identifier: NCT00902915     History of Changes
Other Study ID Numbers: LD
First Posted: May 15, 2009    Key Record Dates
Last Update Posted: November 25, 2013
Last Verified: November 2013

Keywords provided by Austrian Forum Against Cancer:
multiple myeloma renal insufficiency

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Renal Insufficiency
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Kidney Diseases
Urologic Diseases
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents