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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00063726
• Date of registration: 02/07/2003
• Prospective Registration: No
• Primary sponsor: Millennium Pharmaceuticals, Inc.
• Public title: A Study of PS-341 Given to Patients With Multiple Myeloma Who Experienced Progressive Disease After Receiving Dexamethasone in M34101-039
• Scientific 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 Receiving Dexamethasone in Millennium Protocol M34101-039
• Date of first enrolment: April 2002
• Target sample size: 600
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00063726
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Austria, Belgium, Canada, France, Germany, Ireland, Israel, Italy, Netherlands, Spain, Sweden, United Kingdom, United States

Key inclusion & exclusion 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consent may be withdrawn by the patient at any time without prejudice to their future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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Multiple Myeloma

Intervention(s)

Drug: bortezomib

Secondary ID(s)

M34101-040

Source(s) of Monetary Support

Please refer to primary and secondary sponsors