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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 FHCRC Protocol 1746.00


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma and Plasma Cell Neoplasm

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 FHCRC Protocol 1746.00


OBJECTIVES:

- Determine the time to progressive disease in patients with refractory or progressive
multiple myeloma treated with PS-341.

- Determine the safety and tolerability of this drug in these patients.

- Determine survival of patients treated with this drug.

- Determine the rate and duration of response (complete and partial) in patients treated
with this drug.

- Assess the relationship between selected genetic disease markers and response in
patients treated with this drug.

OUTLINE: This is an open-label, multicenter study.

- Induction therapy: Patients receive PS-341 IV on days 1, 4, 8, and 11. Treatment
repeats every 3 weeks for up to 8 courses.

- Maintenance therapy: Patients receive PS-341 IV on days 1, 8, 15, and 22. Treatment
repeats every 5 weeks for up to 3 courses.

Patients who experience progressive disease (PD) after at least 2 courses or no change after
at least 4 courses may also receive oral dexamethasone on the day of and the day after
PS-341 administration. Patients who experience PD after at least 2 courses of this combined
therapy go off study.

Patients are followed at 30 days, every 6 weeks until disease progression, and then every 3
months thereafter.

PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study within 1 year.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of multiple myeloma (MM) and meeting 1 of the following criteria:

- Progressive disease during or after treatment with high-dose dexamethasone on
MPI Study M34101-039 (FHCRC-1746.00), with no other antineoplastic treatment for
MM initiated

- Relapsed or progressive disease after receiving at least 4 prior treatment
regimens for MM (non-MPI patients)

PATIENT CHARACTERISTICS:

Age

- Adult

Performance status

- Karnofsky 60-100% (non-MPI patients)

Life expectancy

- Not specified

Hematopoietic

- Absolute neutrophil count at least 500/mm^3 (no growth factor support)

- Platelet count at least 20,000/mm^3 (transfusions allowed)

- Hemoglobin at least 7.0 g/dL (transfusions allowed)

Hepatic

- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- AST and ALT no greater than 2.5 times ULN

- Hepatitis B surface antigen negative

- No known active hepatitis C infection

Renal

- Calcium less than 14 mg/dL

- Creatinine clearance at least 20 mL/min

Cardiovascular

- Non-MPI patients:

- No myocardial infarction within the past 6 months

- No New York Heart Association class III or IV heart failure

- No uncontrolled angina

- No severe uncontrolled ventricular arrhythmias

- No acute ischemia or active conduction system abnormalities by EKG

- No cardiac amyloidosis

- No poorly controlled hypertension

Other

- All patients:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- HIV negative

- Non-MPI patients:

- No other serious medical or psychiatric illness that would preclude study

- No prior allergic reaction attributable to compounds containing boron or
mannitol

- No peripheral neuropathy grade 2 or greater

- No diabetes mellitus

- No active systemic infection requiring treatment

- MPI patients:

- Recovered from dexamethasone-related toxicity

- No other new or worsening existing illness that would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy

- At least 4 weeks since prior immunotherapy or antibody therapy (non-MPI patients)

- No concurrent thalidomide

Chemotherapy

- At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) (non-MPI
patients)

Endocrine therapy

- See Disease Characteristics

- At least 3 weeks since prior corticosteroids (greater than 10 mg/day of prednisone or
equivalent) (non-MPI patients)

- No other concurrent corticosteroids (e.g., greater than 10 mg/day of prednisone or
equivalent)

Radiotherapy

- Concurrent local short-duration radiotherapy allowed

Surgery

- At least 4 weeks since prior major surgery (except kyphoplasty) (non-MPI patients)

- Concurrent kyphoplasty allowed

- Concurrent emergency orthopedic procedures allowed

Other

- No other concurrent antineoplastic treatment for MM

- No other concurrent investigational agents, including commercial agents approved for
other indications but investigational for MM

- No concurrent clarithromycin

- Concurrent bisphosphonates allowed

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Denise Collins

Investigator Role:

Study Chair

Investigator Affiliation:

Millennium Pharmaceuticals, Inc.

Authority:

United States: Federal Government

Study ID:

CDR0000258110

NCT ID:

NCT00049478

Start Date:

July 2002

Completion Date:

Related Keywords:

  • Multiple Myeloma and Plasma Cell Neoplasm
  • refractory multiple myeloma
  • Neoplasms
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109