MDACC Study Summary 2010-0029

Study Summary
No. 2010-0029:.......Myeloma......Michael Wang......Lymphoma/Myeloma

Study Summary Title



Study Summary Number:	2010-0029

Study Title:	An Open-Label, Single-Arm, Phase 2 Study of Extended Carfilzomib Therapy in Subjects Previously Enrolled in Carfilzomib Treatment Protocols

Physician

New Patient Referral



Name:	Michael Wang	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Lymphoma/Myeloma	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-2860 Contact us about clinical trials

General Information



Disease Group:	Myeloma	Supported By:	Onyx Therapeutics, Inc.

Phase of Study:	Phase II	Return Visit:

Treatment Agents:	Carfilzomib	Home Care:

Treatment Loc:	Both at MDACC & and Other Sites

Estimated Length of Stay in Houston:


Description/ Intervention:	The goal of this clinical research study is to learn if carfilzomib continues to be safe and effective when given long-term (beyond your previous carfilzomib treatment) to treat myeloma.

Study Objectives / Outcomes

To evaluate the safety and efficacy of long-term or continuing carfilzomib treatment in subjects who have
completed a previous carfilzomib treatment study.

For our purpose at MD Anderson we will be enrolling patients with Multiple Myeloma only.

Study Status Information



Study Activation / Registration Date:

IRB Review and Approval Date:	10/19/2010

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Closed

Projected Accrual:	100

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Previous completion of a carfilzomib study within 90 days prior to first dose of extension study drug.

2) Disease Assessments performed within 30 days prior to first dose of maintenance study drug.

3) Written informed consent in accordance with federal, local, and institutional guidelines

4) Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test, with a sensitivity of at least 50 mIU/mL, within 3 days prior to first dose of maintenance study drug.

5) Subjects must agree to adhere to the study visit schedule and other study requirements and receive outpatient treatment and laboratory monitoring at the institution that administers the drug.

Exclusion Criteria:

1) Administration of an intervening chemotherapy between the time of previous carfilzomib study termination and first dose of maintenance study drug.

2) Pregnant or lactating females

3) Diagnosis of a new malignancy of a different tumor type.

Links

Registration Number: NCT00884312
Study Information on Clinical Trials Registry (clinicaltrials.gov)