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A Phase III Multicenter, Randomized, Open-Label Trial Evaluating High Dose Melphalan Plus Holmium-166-DOTMP Versus High Dose Melphalan Alone When Given In Conjuction With Peripheral Blood Stem Cell Transplantation In Patients With Multiple Myeloma


Phase 3
18 Years
70 Years
Not Enrolling
Both
Multiple Myeloma and Plasma Cell Neoplasm

Thank you

Trial Information

A Phase III Multicenter, Randomized, Open-Label Trial Evaluating High Dose Melphalan Plus Holmium-166-DOTMP Versus High Dose Melphalan Alone When Given In Conjuction With Peripheral Blood Stem Cell Transplantation In Patients With Multiple Myeloma


OBJECTIVES: I. Compare the efficacy of melphalan with or without holmium Ho 166 DOTMP
followed by autologous peripheral blood stem cell transplantation in patients with multiple
myeloma. II. Compare the response rate and overall survival of these patients treated with
these regimens. III. Compare the hematologic recovery rate and time to granulocyte
engraftment of these patients treated with these regimens. IV. Compare the toxicity of these
regimens in this patient population.

OUTLINE: This is a randomized, open label, multicenter study. Patients are stratified
according to their beta 2 microglobulin (B2M) test at initial diagnosis (B2M no greater than
4 mg/L vs B2M greater than 4 mg/L vs unknown B2M). Patients are randomized to one of two
treatment arms. Prior to stratification and randomization, patients receive a diagnostic
dose of holmium Ho 166 DOTMP within days -31 to -10. Patients with adequate skeletal uptake
of the diagnostic dose are randomized for therapy. Arm I: Patients receive holmium Ho 166
DOTMP IV over no more than 10 minutes within days -10 to -7 (at least 1 week and no more
than 3 weeks after the diagnostic dose), melphalan IV over 20-30 minutes within days -3 to
-1 (at least 24 hours prior to autologous peripheral blood stem cell (PBSC)
transplantation), and autologous PBSC transplantation on day 0. Arm II: Patients receive
melphalan and autologous PBSC transplantation as in arm I. Following transplantation,
patients receive filgrastim (G-CSF) daily until blood counts recover. Patients are followed
at 1 year, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: Approximately 300 patients (150 per treatment arm) will be accrued for
this study within 9 months.

Inclusion Criteria


DISEASE CHARACTERISTICS: Newly diagnosed multiple myeloma (diagnosis within 12 months of
study) and scheduled to undergo autologous peripheral blood stem cell transplantation
Prior diagnosis of monoclonal gammopathy of undetermined significance (MGUS) or smoldering
myeloma (SMM) allowed if the criteria for diagnosis of multiple myeloma was met within 12
months of study Serum or urinary M-protein confirmation of diagnosis (IgA, IgD, IgG, IgE,
or light chain proteins) At least 10% plasma cells in bone marrow Must have received
induction therapy without disease progression or relapse after initial response Prior
induction therapy must have been completed no more than 6 months before stem cell
collection and no more than 9 months before transplantation Must have undergone stem cell
mobilization with cyclophosphamide IV and filgrastim (G-CSF) The following diagnoses are
excluded: Non-secretory multiple myeloma IgM myeloma Solitary bone or extramedullary
plasmacytoma Symptomatic MGUS or SMM Symptomatic indolent multiple myeloma

PATIENT CHARACTERISTICS: Age: 18 to 70 Performance status: ECOG 0-2 Life expectancy: Not
specified Hematopoietic: See Disease Characteristics Hepatic: Bilirubin no greater than 2
mg/dL SGPT no greater than 2 times upper limit of normal No clinical evidence of
amyloidosis involving the liver Renal: Creatinine no greater than 2.0 mg/dL Creatinine
clearance at least 30 mL/min No clinical evidence of amyloidosis involving the kidney
Cardiovascular: LVEF at least 50% No evidence of amyloidosis on echocardiogram No
uncontrolled arrhythmia No symptomatic cardiac disease Pulmonary: FEV1 at least 60% OR FVC
at least 60% OR DLCO at least 60% No symptomatic pulmonary disease No clinical evidence of
amyloidosis involving the lungs Other: HIV negative No cord compression No other
concurrent illness that would preclude survival No clinical evidence of amyloidosis
involving the autonomic nervous system or gastrointestinal tract No known allergy to
vitamin C Not pregnant or nursing Negative pregnancy test Fertile patients must use
effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics No prior
thalidomide for myeloma No prior peripheral blood stem cell or bone marrow transplantation
No concurrent thalidomide No concurrent interferon Chemotherapy: See Disease
Characteristics No prior clarithromycin for myeloma No more than 2 courses of prior
induction therapy containing an alkylating agent Endocrine therapy: No concurrent
dexamethasone Radiotherapy: No prior radiotherapy to more than 20% of bone marrow No
greater than 30 Gy to the spinal cord Surgery: Not specified Other: At least 28 days since
prior bisphosphonates No prior new or experimental agents for myeloma No concurrent
experimental therapies No concurrent bisphosphonates

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

William I. Bensinger, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fred Hutchinson Cancer Research Center

Authority:

United States: Federal Government

Study ID:

1542.00

NCT ID:

NCT00008229

Start Date:

August 2000

Completion Date:

September 2001

Related Keywords:

  • Multiple Myeloma and Plasma Cell Neoplasm
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • Neoplasms
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109