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

This study has been completed.
Sponsor:
Information provided by:
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00063726
First received: July 2, 2003
Last updated: January 12, 2012
Last verified: January 2012
  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.


Condition Intervention Phase
Multiple Myeloma
Drug: bortezomib
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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 Receiving Dexamethasone in Millennium Protocol M34101-039

Resource links provided by NLM:


Further study details as provided by Millennium Pharmaceuticals, Inc.:

Estimated Enrollment: 600
Study Start Date: April 2002
Study Completion Date: July 2005
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00063726

  Show 76 Study Locations
Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
  More Information

No publications provided by Millennium Pharmaceuticals, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00063726     History of Changes
Obsolete Identifiers: NCT00049478
Other Study ID Numbers: M34101-040
Study First Received: July 2, 2003
Last Updated: January 12, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Millennium Pharmaceuticals, Inc.:
Relapsed Multiple Myeloma
Refractory Multiple Myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Bortezomib
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones

ClinicalTrials.gov processed this record on July 20, 2014