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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2012-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Leukemia Amyloidosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Lenalidomide

Intervention Type DRUG

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.

Melphalan

Intervention Type DRUG

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

Dexamethasone

Intervention Type DRUG

Dexamethasone is an anti-inflammatory and immunosuppressant steroid medication.

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

Interventions

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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.

Intervention Type 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

Intervention Type DRUG

Dexamethasone

Dexamethasone is an anti-inflammatory and immunosuppressant steroid medication.

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

Intervention Type DRUG

Other Intervention Names

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Revlimid L04AX04 Alkeran Evomela Sarcolysin L-phenylalanine mustard (L-PAM) 4-[Bis(2-chloroethyl)amino]-L-phenylalanine Intensol Decadron Baycadron Dexpak® Taperpak Maxidex (dexamethasone ophthalmic suspension) Ozurdex (dexamethasone intravitreal implant)

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No