A Study of PS-341 Given to Patients With Multiple Myeloma Who Experienced Progressive Disease After Receiving Dexamethasone in M34101-039

Completed · Phase 3

Conditions studied: Multiple Myeloma

In brief

The purpose of this study is to allow patients to receive VELCADE™ (bortezomib) for Injection who experienced progressive disease(PD) while receiving high-dose dexamethasone from the M34101-039 study.

Key facts

Study ID: NCT00063726
Run by: Millennium Pharmaceuticals, Inc.
People needed: 600
Starts: 2002-04-01
Expected to finish: 2005-07-01
Last updated by the study team: 2012-01-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patient experienced PD, as defined by SWOG+ criteria during or after treatment with high-dose dexamethasone in MPI Study M34101-039, but has not received alternate anti-neoplastic therapy. Intolerance to high-dose dexamethasone therapy as administered in MPI study M34101-039 does not qualify as PD.
Patient is, in the investigator's opinion, willing and able to comply with the protocol requirements.
Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
Female patient is post-menopausal, surgically sterilized, or willing to use acceptable methods of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) from Screening through the End of Treatment visit.
Male patient agrees to use an acceptable barrier method for contraception from Screening through the End of Treatment visit.
Patient meets the following pretreatment laboratory criteria at and within 14 days before Baseline (Day 1 of Cycle 1, before study drug administration). (Note that the End of Treatment assessments of MPI study M34101-039 may qualify as the Screening assessments for MPI study M34101-040 if performed within 14 days of the Baseline visit.):
Platelet count ≥20 X 10E+9/L, with or without transfusion support.
Hemoglobin ≥7.0 g/dL, with or without transfusion support.
Absolute neutrophil count (ANC)≥0.5 x 10E+9/L, without growth factor support.
Serum calcium <14 mg/dL (3.5 mmol/L).
Aspartate transaminase (AST):≤2.5 x the upper limit of normal (ULN).
Alanine transaminase (ALT):≤2.5 x the ULN.
Total bilirubin:≤1.5 x the ULN.
If calculated or measured creatinine clearance: ≥20 mL/minute, assessments are as specified in the protocol. If calculated or measured creatinine clearance is <20 mL/minute.

You may not qualify if…

Patient participated in M34101-039 and did not have confirmed PD. Dexamethasone intolerance does not qualify as PD.
Patient had PD on the dexamethasone arm of the MPI Study M34101-039, and then received alternate anti-neoplastic therapy.
Patient has not recovered from dexamethasone-related toxicity experienced during MPI Study M34101-039.
Patient is known to be human immunodeficiency virus (HIV)-positive.(Patients assessed by the investigator to be at risk for HIV infection should be tested in accordance with local regulations.)
Patient is known to be hepatitis B surface antigen-positive or has known active hepatitis C infection.(Patients assessed by the investigator to be at risk for hepatitis B or C infection should be tested in accordance with local regulations.)
Female patient is pregnant or breast-feeding.
Patient developed a new or experienced worsening of an existing illness during or after completion of Study M34101-039 that, in the investigator's opinion, may put the patient at risk of participation in this study.

Where it is running

Alta Bates Comprehensive Cancer Center — Berkeley, California, United States
City of Hope — Duarte, California, United States
Scripps Clinic, Green Cancer Center — La Jolla, California, United States
Loma Linda University Medical Center — Loma Linda, California, United States
Kaiser Permanente Medical Center — Vallejo, California, United States
Lombardi Cancer Center, Georgetown University Medical Center — Washington D.C., District of Columbia, United States
Med Star Institute — Washington D.C., District of Columbia, United States
Hematology/Oncology Associates, PA — Jacksonville, Florida, United States
University of Miami — Miami, Florida, United States
H. Lee Moffitt Cancer Center — Tampa, Florida, United States
Emory University — Atlanta, Georgia, United States
Northwestern University Medical School — Chicago, Illinois, United States
Loyola University Medical Center: Cardinal Bernardin Cancer Center — Maywood, Illinois, United States
LSU HC — Sheveport, Louisiana, United States
Tufts England Medical Center — Boston, Massachusetts, United States
Mass General Hospital — Boston, Massachusetts, United States
Dana-Farber Cancer Center — Boston, Massachusetts, United States
Univ. of Michigan Comp. Cancer Center, — Ann Arbor, Michigan, United States
VA Medical Center — Minneapolis, Minnesota, United States
Mayo Clinic — Rochester, Minnesota, United States
Washington University School of Medicine — St Louis, Missouri, United States
Hackensack University Medical Center, David Jurist Research Building — Hackensack, New Jersey, United States
Roswell Park Cancer Institute — Buffalo, New York, United States
Long Island Jewish Medical Center — New Hyde Park, New York, United States
University of Arkansas Medical Sciences — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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