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

NCT00902915 | Unknown Phase 2

• 1 other identifier: LD
• Study Type: interventional
• Target: 50
• Locations: 2 countries
• Sites: 5

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.

Conditions

Multiple Myeloma Light Chain Induced Renal Insufficiency

Keywords

multiple myeloma renal insufficiency

Outcome Measures

Primary Outcomes (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 Outcomes (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).

Study Arms (1)

Lenalidomide - Dexamethasone

EXPERIMENTAL

Drug: lenalidomide plus dexamethasone

Interventions

lenalidomide plus dexamethasone DRUG

peroral application; lenalidomide dosage according to severity grade of renal failure.

Lenalidomide - Dexamethasone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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

Sponsors & Collaborators

• Austrian Forum Against Cancer: lead

Study Sites (5)

LKH Salzburg, 3rd Med. Dept.

Salzburg, 5020, Austria

Location

Austrian Forum Against Cancer; 1st Med. Dept., Center for Hematology and Oncology, Wilhelminenspital, Montleartstrasse 37

Vienna, 1160, Austria

Location

Clinic Wels-Grieskirchen, 4th Internal Dept.

Wels, 4600, Austria

Location

Faculty Hospital Brno and Faculty of Medicine MU

Brno, 62500, Czechia

Location

Charles University Prague

Prague, 12821, Czechia

Location

MeSH Terms

Interventions

Lenalidomide; Dexamethasone

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2009
• First Posted: May 15, 2009
• Study Start: May 1, 2009
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: November 25, 2013

Record last verified: 2013-11

Locations

AU (3); CZ (2)