Expired Study
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Berkeley, California 94704


Purpose:

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.


Study summary:

The rationale for Amendment 2 is 2-fold. First, it is intended that this study serve as a rollover protocol for patients who experience progressive disease (PD) after receiving the comparator treatment, high-dose dexamethasone, in MPI Study M34101-039, thereby ultimately providing all patients who participate in Study M34101-039 and require treatment for their disease access to VELCADE™ (bortezomib) for Injection, formerly known as MLN341, LDP-341 and PS-341.


Criteria:

Inclusion Criteria - 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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.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. Exclusion Criteria - 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.


Study is Available At:


Original ID:

M34101-040


NCT ID:

NCT00063726


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

An International, Non-Comparative, Open-Label Study of PS-341 Administered to Patients With Multiple Myeloma Who Experienced Relapsed or Progressive Disease After Receiving at Least Four Previous Treatment Regimens or Experienced Progressive Disease After


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Millennium Pharmaceuticals, Inc.


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

600


Enrollment Type:


Study Dates

Start Date:April 2002
Completion Date:July 2005
Completion Type:Actual
Primary Completion Date:May 2005
Primary Completion Type:Actual
Verification Date:January 2012
Last Changed Date:January 12, 2012
First Received Date:July 2, 2003

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:bortezomib

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Millennium Pharmaceuticals, Inc.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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