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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma

Thank you

Trial Information

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


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.

Inclusion 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consent may be withdrawn by the patient at any time without prejudice to their future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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

M34101-040

NCT ID:

NCT00063726

Start Date:

April 2002

Completion Date:

July 2005

Related Keywords:

  • Multiple Myeloma
  • Relapsed Multiple Myeloma
  • Refractory Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

MD Anderson Cancer CenterHouston, Texas  77030-4096
Cleveland Clinic FoundationCleveland, Ohio  44195
Roswell Park Cancer InstituteBuffalo, New York  14263
Mayo ClinicRochester, Minnesota  55905
Washington University School of MedicineSaint Louis, Missouri  63110
University of Pennsylvania Cancer CenterPhiladelphia, Pennsylvania  19104
Medical College of WisconsinMilwaukee, Wisconsin  53226
Loma Linda University Medical CenterLoma Linda, California  92354
Western Pennsylvania HospitalPittsburgh, Pennsylvania  15224
Long Island Jewish Medical CenterNew Hyde Park, New York  11040
Rochester General HospitalRochester, New York  14621
Alta Bates Comprehensive Cancer CenterBerkeley, California  94704
City of HopeDuarte, California  91010
St. Vincent's Comprehensive Cancer CenterNew York, New York  10011
Trident Palmetto Hematology/OncologyNorth Charleston, South Carolina  29406
H. Lee Moffitt Cancer CenterTampa, Florida  33612
Emory UniversityAtlanta, Georgia  30322
Kaiser Permanente Medical CenterVallejo, California  94589
Northwestern University Medical SchoolChicago, Illinois  60611-2927
VA Medical CenterMinneapolis, Minnesota  
Lombardi Cancer Center, Georgetown University Medical CenterWashington, District of Columbia  20007
Hematology/Oncology Associates, PAJacksonville, Florida  32207
University of MiamiMiami, Florida  33136
Loyola University Medical Center: Cardinal Bernardin Cancer CenterMaywood,, Illinois  60153
LSU HCShreveport, Louisiana  71130
Dana-Farber Cancer CenterBoston, Massachusetts  02115
Hackensack University Medical Center, David Jurist Research BuildingHackensack, New Jersey  07601
University of Rochester Medical Center, James P. Wilmot Cancer CenterRochester, New York  14642
Division of Hematology/Stem Cell TransplantNashville, Tennessee  37232-5505
Texas Oncology at Medical City Dallas HospitalDallas, Texas  75225
Fred Hutchinson Cancer CenterSeattle, Washington  98109
University of Arkansas Medical SciencesLittle Rock, Arkansas  72205
Scripps Clinic, Green Cancer CenterLa Jolla, California  92307
Med Star InstituteWashington, District of Columbia  20010
Mass General HospitalBoston, Massachusetts  02114
Tufts England Medical CenterBoston, Massachusetts  02111
Univ. of Michigan Comp. Cancer Center,Ann Arbor, Michigan  48109-0922
Weill Medical College of Cornell University, NY Presbyterian HospitalNew York, New York  10021
Charlotte Hematology Oncology AssociatesCharlotte, North Carolina  28203