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A Pilot Study of Lenalidomide, Melphalan and Dexamethasone in AL Amyloidosis

This study has been completed.
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Stanley L Schrier, Stanford University
ClinicalTrials.gov Identifier:
NCT00890552
First received: April 28, 2009
Last updated: February 1, 2017
Last verified: February 2017
April 28, 2009
February 1, 2017
April 2009
August 2012   (Final data collection date for primary outcome measure)
Hematologic Response Rate [ Time Frame: 8 weeks ]
At the end of each treatment cycle (4 weeks), hematologic response rate as assessed. Hematologic response was considered to be amyloid complete response (normal FLC ratio and negative serum and urine immunofixation); very good partial response (difference between involved and uninvolved FLCs [dFLC] < 40 mg/L); or partial response (dFLC decrease > 50%).
Safety and tolerability of Intervention
Complete list of historical versions of study NCT00890552 on ClinicalTrials.gov Archive Site
  • Overall Survival (OS) [ Time Frame: 12 months ]
    Participants alive 12 months after starting MDR treatment.
  • Event-free Survival (EFS) [ Time Frame: 12 months ]
    Assessed as the median value for EFS 12 months after starting MDR treatment
  • Duration of Response [ Time Frame: 32 months ]
    Assessed as the median value for the time from first partial response until progression; death; or last follow-up.
Hematologic and organ responses, time to progression
Not Provided
Not Provided
 
A Pilot Study of Lenalidomide, Melphalan and Dexamethasone in AL Amyloidosis
A Pilot Study of Lenalidomide, Melphalan and Dexamethasone in AL Amyloidosis
This open-label trial will evaluate the use of lenalidomide; melphalan; and dexamethasone (MDR) to treat newly diagnosed or relapsed AL amyloidosis, over the course of nine 28-day cycles.
The study will evaluate the 3-drug combination of lenalidomide; melphalan; and dexamethasone (MDR) as the absence of disease progression or toxicity, patients will complete nine 28-day cycles of MDR therapy, with the option of continuing treatment with lenalidomide as single-agent. Patients received up to nine cycles of treatment, with the option to continue on lenalidomide as a single agent if they responded to treatment.
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Leukemia
  • Amyloidosis
  • Drug: Lenalidomide

    Lenalidomide is a a derivative of thalidomide.

    Orally-administered lenalidomide 10 mg will be taken daily on days 1 to 21 of 28-day cycle.

    Other Names:
    • Revlimid
    • L04AX04
  • Drug: Melphalan

    Melphalan is a phenylalanine derivative of mechlorethamine.

    Orally-administered melphalan 0.18 mg/kg will be taken on days 1 to 4 of a 28-day cycle

    Other Names:
    • Alkeran
    • Evomela
    • Sarcolysin
    • L-phenylalanine mustard (L-PAM)
    • 4-[Bis(2-chloroethyl)amino]-L-phenylalanine
  • Drug: Dexamethasone

    Dexamethasone is an anti-inflammatory and immunosuppressant steroid medication.

    Orally-administered dexamethasone 40 mg orally once weekly of a 28-day cycle

    Other Names:
    • Intensol
    • Decadron
    • Baycadron
    • Dexpak® Taperpak
    • Maxidex (dexamethasone ophthalmic suspension)
    • Ozurdex (dexamethasone intravitreal implant)
Experimental: Lenalidomide+Melphalan+Dexamethasone
Patients received lenalidomide 10 mg/day orally on days 1-21, melphalan 0.18 mg/kg orally on days 1-4, and dexamethasone 40 mg orally once weekly of a 28-day cycle (MDR treatment).
Interventions:
  • Drug: Lenalidomide
  • Drug: Melphalan
  • Drug: Dexamethasone

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
October 2012
August 2012   (Final data collection date for primary outcome measure)

INCLUSION CRITERIA

  • Newly diagnosed or relapsed AL amyloidosis
  • Biopsy-proven amyloidosis with evidence of an underlying plasma cell dyscrasia

    • abnormal clonal dominance of plasma cells in the bone marrow
    • detection of a monoclonal gammopathy by immunofixation electrophoresis of serum and/or urine
    • an abnormal serum free light chain or ratio, or AL fibrils seen on biopsy)
  • Measurable disease defined by an abnormal serum-free light chain or monoclonal protein by immunofixation

    • proteinuria ≥ 0.5 g/day, cardiac involvement with interventricular septal thickness ≥ 15 mm
    • hepatomegaly in the absence of congestive heart failure with elevated alkaline phosphatase
  • Age ≥ 18 years at the time of signing the informed consent form.
  • All previous cancer therapy must have been discontinued at least 4 weeks prior to treatment in this study
  • ECOG performance status of ≤ 3 at study entry
  • Laboratory test results:

    • Absolute neutrophil count ≥ 1.0 x 10e9 / L
    • Platelet count ≥ 75 x 10e9 / L
    • Creatinine clearance ≥ 15 mL/ minute
    • Total bilirubin ≤ 2-fold upper limits of normal
  • Disease-free of prior malignancies (excluding multiple myeloma) for ≥ 3 years with exception of:

    • currently treated basal cell
    • squamous cell carcinoma of the skin
    • carcinoma "in situ" of the cervix or breast.
  • Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test
  • Females of childbearing potential must either:

    • commit to continued abstinence from heterosexual intercourse
    • acceptable methods of birth control and agree to ongoing pregnancy testing
  • Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy
  • All study participants must be registered into the mandatory RevAssist program, and able to comply with its requirements
  • Able to take aspirin (81 mg) daily • Understand and voluntarily sign an informed consent form
  • Able to adhere to the study visit schedule and other protocol requirements

EXCLUSION CRITERIA

  • Any serious medical condition that would prevent the subject from signing the informed consent form
  • Pregnant
  • breast-feeding females
  • Use of any other experimental drug or therapy within 28 days of baseline
  • Known hypersensitivity to thalidomide
  • Erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs
  • Any prior use of lenalidomide
  • Concurrent use of other anti-cancer agents or treatments
  • Known positivity for human immunodeficiency virus HIV)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00890552
IRB-15213
RV-AMYL-PI-0375 ( Other Identifier: Celgene Reference number )
SU-09192008-1300 ( Other Identifier: Stanford University )
HEM0010 ( Other Identifier: OnCore )
Yes
Not Provided
Plan to Share IPD: No
Stanley L Schrier, Stanford University
Stanford University
Celgene Corporation
Principal Investigator: Stanley L Schrier, MD Stanford University
Stanford University
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP