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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
Results First Received: April 14, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Treatment
Conditions: Leukemia
Amyloidosis
Interventions: Drug: Lenalidomide
Drug: Melphalan
Drug: Dexamethasone

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Lenalidomide, Melphalan and Dexamethasone (MDR)

The 3-drug combination of orally-administered lenalidomide; melphalan; and dexamethasone (MDR) will be administered as nine 28-day cycles, with the option of continuing treatment with lenalidomide as single-agent.

Lenalidomide: Orally-administered lenalidomide 10 mg will be taken daily on days 1 to 21 of 28-day cycle. Lenalidomide is a a derivative of thalidomide.

Melphalan: Orally-administered melphalan 0.18 mg/kg will be taken on days 1 to 4 of a 28-day cycle. Melphalan is a phenylalanine derivative of mechlorethamine.

Dexamethasone: Orally-administered dexamethasone 40 mg will be taken on days 1; 8; 15; and 22 of a 28-day cycle. Dexamethasone is an anti-inflammatory and immunosuppressant steroid medication.


Participant Flow for 2 periods

Period 1:   Enrollment and Pre-treatment
    Lenalidomide, Melphalan and Dexamethasone (MDR)
STARTED   25 
COMPLETED   24 
NOT COMPLETED   1 
Death/ lost to follow up                1 

Period 2:   On-treatment
    Lenalidomide, Melphalan and Dexamethasone (MDR)
STARTED   24 
COMPLETED   14 
NOT COMPLETED   10 
Early prog disease/ death                10 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Lenalidomide-naïve adults with biopsy-proven amyloidosis manifested as measurable disease, ECOG ≤ 3

Reporting Groups
  Description
Lenalidomide, Melphalan and Dexamethasone (MDR) The 3-drug combination of orally-administered lenalidomide; melphalan; and dexamethasone (MDR) will be administered as nine 28-day cycles, with the option of continuing treatment with lenalidomide as single-agent.

Baseline Measures
   Lenalidomide, Melphalan and Dexamethasone (MDR) 
Overall Participants Analyzed 
[Units: Participants]
 25 
Age 
[Units: Years]
Median (Full Range)
 67 
 (52 to 84) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      9  36.0% 
Male      16  64.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      2   8.0% 
Not Hispanic or Latino      21  84.0% 
Unknown or Not Reported      2   8.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      1   4.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      0   0.0% 
White      23  92.0% 
More than one race      0   0.0% 
Unknown or Not Reported      1   4.0% 
ECOG Performance Status (PS) [1] 
[Units: Participants]
 
ECOG PS 1   12 
ECOG PS 2   9 
ECOG PS 3   4 
[1]

ECOG Performance Status. PS 0 = Fully active, able to carry on all pre-disease performance without restriction.

PS 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.

PS 2 = Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours. PS 3 = Capable of only limited self-care, confined to bed or chair more than 50% of waking hours..

Hematologic disease burden 
[Units: Percentage of participants]
 
Kappa free light chain (%)   20 
Lambda free light chain (%)   80 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Hematologic Response Rate   [ Time Frame: 8 weeks ]

2.  Secondary:   Overall Survival (OS)   [ Time Frame: 12 months ]

3.  Secondary:   Event-free Survival (EFS)   [ Time Frame: 12 months ]

4.  Secondary:   Duration of Response   [ Time Frame: 32 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Brenda Hann, RN, MBA, CCRC
Organization: Stanford University School of Medicine
phone: 650-723-0966
e-mail: bhann@stanford.edu


Publications of Results:
Other Publications:

Responsible Party: Stanley L Schrier, Stanford University
ClinicalTrials.gov Identifier: NCT00890552     History of Changes
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 )
Study First Received: April 28, 2009
Results First Received: April 14, 2016
Last Updated: February 1, 2017