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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Austrian Forum Against Cancer
ClinicalTrials.gov Identifier:
NCT00902915
First received: May 14, 2009
Last updated: November 21, 2013
Last verified: November 2013
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

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 [ Designated as safety issue: Yes ]

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). [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: May 2009
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lenalidomide - Dexamethasone 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
Accepts Healthy Volunteers:   No
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Austria
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
  More Information

No publications provided

Responsible Party: Austrian Forum Against Cancer
ClinicalTrials.gov Identifier: NCT00902915     History of Changes
Other Study ID Numbers: LD
Study First Received: May 14, 2009
Last Updated: November 21, 2013
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

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Renal Insufficiency
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Kidney Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Urologic Diseases
Vascular Diseases
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Lenalidomide
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 20, 2014