Bortezomib, Cyclophosphamide, and Dexamethasone in Treating Patients With Primary Systemic Light Chain Amyloidosis

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Mayo Clinic

ClinicalTrials.gov Identifier:

NCT01072773

First received: February 17, 2010

Last updated: November 7, 2012

Last verified: November 2012

History of Changes

Results First Received: November 7, 2012

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Primary Systemic Amyloidosis
Interventions:	Drug: bortezomib Drug: cyclophosphamide 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
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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
Bortez/Cyc/Dex	Bortezomib IV on days 1, 8, and 15, oral cyclophosphamide and oral dexamethasone once daily on days 1, 8, 15, and 22.

Participant Flow: Overall Study

	Bortez/Cyc/Dex
STARTED	2
COMPLETED	2
NOT COMPLETED	0

Baseline Characteristics

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Reporting Groups

	Description
Bortez/Cyc/Dex	Bortezomib IV on days 1, 8, and 15, oral cyclophosphamide and oral dexamethasone once daily on days 1, 8, 15, and 22.

Baseline Measures

	Bortez/Cyc/Dex
Number of Participants [units: participants]	2
Age [units: participants]
<=18 years	0
Between 18 and 65 years	0
>=65 years	2
Age [units: years] Median ( Full Range )	69 ( 67 to 71 )
Gender [units: participants]
Female	2
Male	0
Region of Enrollment [units: participants]
United States	2
Prior Treatment ^[1] [units: Prior Treatments] Mean ( Full Range )	6.5 ( 1 to 11 )

[1]	Number of previous regimens used for the treatment of amyloidosis. There is no limit to the number of prior therapies provided there is adequate residual organ function.

Outcome Measures

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1. Primary:

Number of Participants With a Confirmed Hematologic Response [ Time Frame: Duration of treatment (up to 12 cycles/months) ]

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2. Secondary:

Number of Participants With Treatment Related Adverse Events. [ Time Frame: Duration on treatment (up to 12 cycles/months) ]

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3. Secondary:

Number of Participants With an Organ Response. [ Time Frame: Duration on treatment (up to 12 cycles/months) ]

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4. Secondary:

Overall Survival [ Time Frame: Duration of Study (up to 5 years) ]

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5. Secondary:

Time to Disease Progression [ Time Frame: Duration of Study (up to 5 years) ]

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6. Secondary:

Duration of Response [ Time Frame: Duration of Study (up to 5 years) ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

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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Results Point of Contact:

Name/Title: Dr. Shaji Kumar
Organization: Mayo Clinic
e-mail: kumar.shaji@mayo.edu

No publications provided

Responsible Party:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT01072773 History of Changes
Other Study ID Numbers:	MC0985, NCI-2009-01564, 09-005736, MC0985, X05306
Study First Received:	February 17, 2010
Results First Received:	November 7, 2012
Last Updated:	November 7, 2012
Health Authority:	United States: Food and Drug Administration

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