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

Not Applicable

Completed

• Conditions: Leukemia; Amyloidosis
• Interventions: Drug: Lenalidomide; Drug: Melphalan; Drug: Dexamethasone

• Registration Number: NCT00890552
• Lead Sponsor: Stanford University

Brief 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.

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 Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-04-28
• Study First Submitted QC: 2009-04-29
• Study First Posted: 2009-04-30
• Primary Completion: 2012-08
• Study Completion: 2012-10
• Results First Submitted: 2016-04-14
• Status Verified: 2017-02
• Results First Submitted QC: 2017-02-01
• Last Update Submitted: 2017-02-01
• Results First Posted: 2017-03-22
• Last Update Posted: 2017-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lenalidomide+Melphalan+Dexamethasone	Melphalan	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).
Lenalidomide+Melphalan+Dexamethasone	Lenalidomide	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).
Lenalidomide+Melphalan+Dexamethasone	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).

Primary Outcome Measures

Name	Time	Method
Hematologic Response Rate	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%).

Secondary Outcome Measures

Name	Time	Method
Duration of Response	32 months	Assessed as the median value for the time from first partial response until progression; death; or last follow-up.
Overall Survival (OS)	12 months	Participants alive 12 months after starting MDR treatment.
Event-free Survival (EFS)	12 months	Assessed as the median value for EFS 12 months after starting MDR treatment

Trial Locations

Locations (1)

Stanford University Cancer Institute; 🇺🇸 Stanford, California, United States