N/A N=25 Treatment

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

Leukemia · Amyloidosis

Bottom Line

View on ClinicalTrials.gov: NCT00890552 ↗

Enrolled (actual)

Serious AEs

76.0%

Results posted

Mar 2017

Primary outcome: Primary: Hematologic Response Rate — 2; 4; 8; 9 participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Lenalidomide (Drug); Melphalan (Drug); Dexamethasone (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Stanford University
Primary completion: Aug 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Hematologic Response Rate	2; 4; 8; 9; 1	—
SECONDARY Overall Survival (OS)	58	—
SECONDARY Event-free Survival (EFS)	3.15	—
SECONDARY Duration of Response	9.1	—

Summary

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.

Eligibility Criteria

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00890552). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.