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Lenalidomide and Dexamethasone for Treatment of Patients With Acute Myeloma (Light Chain)-Induced Renal Failure
This study is currently recruiting participants.
Verified by Austrian Forum Against Cancer, May 2009
First Received: May 14, 2009   No Changes Posted
Sponsored by: Austrian Forum Against Cancer
Information provided by: Austrian Forum Against Cancer
ClinicalTrials.gov Identifier: NCT00902915
  Purpose

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 Intervention Phase
Multiple Myeloma Light Chain Induced Renal Insufficiency
Drug: lenalidomide plus dexamethasone
Phase II

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Resource links provided by NLM:


Further study details as provided by Austrian Forum Against Cancer:

Primary Outcome Measures:
  • 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:
  • 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).

Estimated Enrollment: 50
Study Start Date: May 2009
Estimated Study Completion Date: May 2014
Intervention Details:
    Drug: lenalidomide plus dexamethasone
    peroral application; lenalidomide dosage according to severity grade of renal failure.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00902915

Contacts
Contact: Heinz P. Ludwig, Prof. Dr. +43 1 49150 ext 2101 heinz.ludwig@wienkav.at

Locations
Austria
Austrian Forum Against Cancer; 1st Med. Dept., Center for Hematology and Oncology, Wilhelminenspital, Montleartstrasse 37 Recruiting
Vienna, Austria, 1160
Principal Investigator: Heinz P. Ludwig, Prof. Dr.            
Med. University Vienna, Clinic for Internal Medicine 1 (Hematology and Hemostaseology) Not yet recruiting
Vienna, Austria, 1090
Contact: Heinz Gisllinger, Prof. Dr.     +43 1 40400 ext 5464     heinz.gisslinger@meduniwien.ac.at    
Med. University Vienna, Clinic for Internal Medicine I, Dept. for Oncology Not yet recruiting
Vienna, Austria, 1090
Contact: Johannes Drach, Prof. Dr.     +43 1 40400 ext 4466     johannes.drach@meduniwien.ac.at    
Clinic Wels-Grieskirchen, 4th Internal Dept. Recruiting
4600, Austria, Wels
Contact: Josef Thaler, Prof. Dr.     +43 7242 415     josef.thaler@klinikum-wegr.at    
LKH Salzburg, 3rd Med. Dept. Recruiting
Salzburg, Austria, 5020
Contact: Richard Greil, Prof. Dr.     +43 662 4482 ext 2879     r.greil@salk.at    
LKH Leoben, Dept. for Internal Medicine Recruiting
Leoben, Austria, 8700
Contact: Felix Keil, Prof. Dr.     +43 3842 401 ext 2821     felix.keil@lkh-leoben.at    
LKH Feldkirch, Internal Dept. Not yet recruiting
Feldkirch, Austria, 6807
Contact: Alois Lang, Dr.     +43 5522 303     alois.lang@lkhf.at    
Czech Republic
Faculty Hospital Brno and Faculty of Medicine MU Not yet recruiting
Brno, Czech Republic, 62500
Contact: Zdenek Adam, Prof. Dr.            
Charles University Prague Not yet recruiting
Prague, Czech Republic, 12821
Contact: Ivan Spicka, Prof. Dr.            
Slovakia
Hospital of St. Cyril and Method Bratislava Not yet recruiting
Brastislava, Slovakia, 85107
Contact: Martin Mistrik, Ass. Prof. Dr.            
Faculty Hospital with Policlinic Kosice Not yet recruiting
Kosice, Slovakia
Contact: Elena Tothova, Prof. Dr.            
Sponsors and Collaborators
Austrian Forum Against Cancer
  More Information

No publications provided

Responsible Party: Austian Forum Against Cancer ( Prof. Dr. Heinz Ludwig )
Study ID Numbers: LD
Study First Received: May 14, 2009
Last Updated: May 14, 2009
ClinicalTrials.gov Identifier: NCT00902915     History of Changes
Health Authority: Austria: Agency for Health and Food Safety;   Czech Republic: State Institute for Drug Control;   Slovakia: State Institute for Drug Control

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

Study placed in the following topic categories:
Anti-Inflammatory Agents
Dexamethasone
Renal Insufficiency
Blood Protein Disorders
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Paraproteinemias
Hemostatic Disorders
Hormones
Hemorrhagic Disorders
Urologic Diseases
Kidney Diseases
Dexamethasone acetate
Immunoproliferative Disorders
Antineoplastic Agents, Hormonal
Hematologic Diseases
Blood Coagulation Disorders
Vascular Diseases
Lenalidomide
Glucocorticoids
Multiple Myeloma
Peripheral Nervous System Agents
Lymphoproliferative Disorders
Kidney Failure
Neoplasms, Plasma Cell

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Dexamethasone
Renal Insufficiency
Antineoplastic Agents
Blood Protein Disorders
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Paraproteinemias
Hemostatic Disorders
Hormones
Hemorrhagic Disorders
Urologic Diseases
Therapeutic Uses
Cardiovascular Diseases
Kidney Diseases
Dexamethasone acetate
Neoplasms by Histologic Type
Immunoproliferative Disorders
Antineoplastic Agents, Hormonal
Immune System Diseases
Hematologic Diseases
Gastrointestinal Agents
Vascular Diseases
Lenalidomide
Glucocorticoids
Pharmacologic Actions
Multiple Myeloma
Neoplasms
Autonomic Agents

ClinicalTrials.gov processed this record on September 10, 2009