CC-5013 With or Without Dexamethasone in Treating Patients With Primary Systemic Amyloidosis

NCT00091260 | Completed Phase 2 Results DMC

• 3 other identifiers: CDR0000385687BUMC-H-23235CELGENE-RV-AMYL-PI-003
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs such as CC-5013 and dexamethasone may be effective in treating primary systemic amyloidosis. PURPOSE: This phase II trial is studying CC-5013 to see how well it works with or without dexamethasone in treating patients with primary systemic amyloidosis.

Conditions

Multiple Myeloma

Keywords

primary systemic amyloidosis

Outcome Measures

Primary Outcomes (2)

• Number of Patients Removed From Study Treatment Due to Toxicities

  1 year

• Number of Patients With Hematologic Response With Single-agent CC-5013

  Complete response = Absence of detectable monoclonal protein in serum or urine by immunofixation electrophoresis, less than 5% plasma cells on bone marrow biopsy without clonal dominance of kappa or lambda isotype, and normal serum free light chain assay. Partial response= For patients with detectable and quantifiable monoclonal marrow plasmacytosis= a reduction of 50% or more in plasma cells as a percentage of nucleated bone marrow cells. For patients with a detectable monoclonal peak on serum or urine protein electrophoresis= a reduction in the peak height of 50% or more. For patients with quantifiable urinary kappa or lambda chain concentration= a 50% reduction in daily light chain excretion in 24 hour urine. For patients with an elevated serum free light chain assay, a reduction of 50% or more.

  3 months

Secondary Outcomes (1)

• Number of Patients Who Received Both CC-5013 and Dexamethasone and Had a Hematologic Response

  1 year

Study Arms (1)

revlimid

EXPERIMENTAL

lenalidomide 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone 20 mg daily (10 mg BID) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.

Drug: dexamethasone; Drug: lenalidomide

Interventions

dexamethasone DRUG

dexamethasone 20 mg daily (10 mg BID) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.

Also known as: dexamethasone acetate

revlimid

lenalidomide DRUG

15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone

Also known as: revlimid; CC-5013

revlimid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• DISEASE CHARACTERISTICS:
• Histologically confirmed primary systemic (AL) amyloidosis
• Tissue amyloid deposits or positive fat aspirate
• Meets 1 of the following criteria for AL type disease:
• Serum or urine monoclonal protein by immunofixation electrophoresis
• Plasmacytosis of bone marrow by monoclonal staining for kappa- or lambda-light chain isotype
• PATIENT CHARACTERISTICS:
• Age
• and over
• Performance status
• SWOG 0-2
• Life expectancy
• Not specified
• Hematopoietic
• White blood count\> 3,000/mm\^3

You may not qualify if:

• No secondary or familial amyloidosis
• No multiple myeloma, defined as ≥ 30% plasma cells in bone marrow biopsy specimen OR lytic bone lesions
• No prior CC-5013
• Renal
• No dialysis
• Cardiovascular
• No symptomatic cardiac arrhythmia
• No oxygen-dependent restrictive cardiomyopathy
• Other
• No untreated or uncontrolled infection
• No other malignancy except basal cell skin cancer or carcinoma in situ of the cervix or breast
• No other serious medical illness that would preclude study participation
• No history of hypersensitivity reaction to thalidomide
• HIV negative
• Not pregnant or nursing

Sponsors & Collaborators

• Vaishali Sanchorawala: lead
• Celgene Corporation: collaborator

Study Sites (1)

Cancer Research Center at Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Related Publications (1)

• Lichtman EI, Seldin DC, Shelton A, Sanchorawala V. Single agent lenalidomide three times a week induces hematologic responses in AL amyloidosis patients on dialysis. Am J Hematol. 2014 Jul;89(7):706-8. doi: 10.1002/ajh.23722. Epub 2014 Apr 10.

  PMID: 24668858 DERIVED

MeSH Terms

Conditions

Multiple Myeloma; Immunoglobulin Light-chain Amyloidosis

Interventions

Dexamethasone; dexamethasone acetate; Lenalidomide

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Amyloidosis; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Vaishali Sanchorawala
• Organization: Boston Medical Center

vaishali.sanchorawala@bmc.org

6176386521

Study Officials

• David C. Seldin, MD, PhD

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 7, 2004
• First Posted: September 9, 2004
• Study Start: January 1, 2004
• Primary Completion: July 1, 2012
• Study Completion: May 1, 2015
• Last Updated: February 20, 2017
• Results First Posted: February 20, 2017

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)