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

February 1, 2017 updated by: Stanley L Schrier, Stanford University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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).
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:
  • Decadron
  • Baycadron
  • Intensol
  • Dexpak® Taperpak
  • Maxidex (dexamethasone ophthalmic suspension)
  • Ozurdex (dexamethasone intravitreal implant)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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%).
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: 12 months
Participants alive 12 months after starting MDR treatment.
12 months
Event-free Survival (EFS)
Time Frame: 12 months
Assessed as the median value for EFS 12 months after starting MDR treatment
12 months
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.
32 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

Celgene Corporation

Investigators

  • Principal Investigator: Stanley L Schrier, MD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

April 28, 2009

First Submitted That Met QC Criteria

April 29, 2009

First Posted (Estimate)

April 30, 2009

Study Record Updates

Last Update Posted (Actual)

March 22, 2017

Last Update Submitted That Met QC Criteria

February 1, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-15213
  • RV-AMYL-PI-0375 (Other Identifier: Celgene Reference number)
  • SU-09192008-1300 (Other Identifier: Stanford University)
  • HEM0010 (Other Identifier: OnCore)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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