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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.
First Received: July 2, 2003   Last Updated: July 12, 2007   History of Changes
Sponsored by: Millennium Pharmaceuticals, Inc.
Information provided by: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00063726
  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 III

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
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
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
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

Study ID Numbers: M34101-040
Study First Received: July 2, 2003
Last Updated: July 12, 2007
ClinicalTrials.gov Identifier: NCT00063726     History of Changes
Health Authority: United States: Food and Drug Administration

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

Study placed in the following topic categories:
Anti-Inflammatory Agents
Dexamethasone
Immunoproliferative Disorders
Antineoplastic Agents, Hormonal
Blood Protein Disorders
Hematologic Diseases
Hormone Antagonists
Blood Coagulation Disorders
Bortezomib
Hormones, Hormone Substitutes, and Hormone Antagonists
Vascular Diseases
Antiemetics
Paraproteinemias
Hemostatic Disorders
Hormones
Glucocorticoids
Protease Inhibitors
Multiple Myeloma
Hemorrhagic Disorders
Peripheral Nervous System Agents
Lymphoproliferative Disorders
Dexamethasone acetate
Neoplasms, Plasma Cell

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Dexamethasone
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Blood Protein Disorders
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Paraproteinemias
Hemostatic Disorders
Hormones
Hemorrhagic Disorders
Therapeutic Uses
Cardiovascular Diseases
Immunoproliferative Disorders
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Immune System Diseases
Hematologic Diseases
Bortezomib
Vascular Diseases
Gastrointestinal Agents
Enzyme Inhibitors
Glucocorticoids
Pharmacologic Actions
Protease Inhibitors
Multiple Myeloma
Neoplasms
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on September 02, 2009