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S9805, Phase II Study of Tandem High Dose Melphalan Supported by Peripheral Blood Stem Cell Support in Waldenstrom's Macroglobulinemia (WM)

Phase 2
69 Years
Not Enrolling

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Trial Information

S9805, Phase II Study of Tandem High Dose Melphalan Supported by Peripheral Blood Stem Cell Support in Waldenstrom's Macroglobulinemia (WM)

OBJECTIVES: I. Assess remission rates and overall and progression-free survival in patients
with Waldenstrom's macroglobulinemia treated with tandem high dose melphalan supported by
peripheral blood stem cell support. II. Assess the associated hematologic and nonhematologic
toxicities of this regimen in these patients.

OUTLINE: Regimen A (dexamethasone induction): All patients receive high dose dexamethasone
orally on days 1-4, 9-12, and 17-20; courses repeat every 35 days for a total of 3 courses.
Regimen B (stem cell mobilization and collection): Following a 4-6 week break after
dexamethasone induction and regardless of response or progression, patients have stem cells
collected following administration of filgrastim (G-CSF) by injection; G-CSF continues until
completion of stem cell collection (maximum of 6 aphereses). Regimen C (first peripheral
blood stem cell transplant (PBSCT)): Regardless of disease progression, patients recovered
from toxicities from dexamethasone induction and stem cell mobilization and collection, and
who have adequate number of CD34 cells collected for at least 1 transplant, receive 1 dose
of melphalan daily for 2 days followed by peripheral stem cell reinfusion. G-CSF is given by
injection beginning on the day after peripheral stem cell reinfusion and continues until the
absolute granulocyte count is greater than 1,000/mm3 on 3 consecutive days. Regimen D
(second PBSCT): Patients who had adequate stem cell collection for 2 transplants during
regimen B, have no evidence of disease progression after the first transplant, and have
recovered from effects of previous treatment undergo a second treatment with high dose
melphalan with PBSCT and G-CSF support, given 3-12 months following the first transplant.
Patients who had enough cells collected for only one transplant go directly to regimen E.
Regimen E (maintenance interferon alfa): Beginning 5-12 weeks after transplant and upon
hematologic recovery of blood counts and other toxicities, patients with at least a partial
response after high dose melphalan and PBSCT receive subcutaneous interferon alfa injections
3 times a week for 5 years or until disease progression, relapse, or toxicity. Patients are
followed every month for 6 months, then every 3 months for 5 years, then annually

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study over 4 years.

Inclusion Criteria

DISEASE CHARACTERISTICS: Immunologically diagnosed Waldenstrom's macroglobulinemia (WM)
Evaluable quantifiable IgM One of the following criteria must be met: 1) Patient
demonstrates clinical symptoms such as fatigue, dizziness, visual inacuity, or hemorrhagic
manifestations of WM with anemia, hyperviscosity, thrombocytopenia, or coagulopathies 2)
Advanced tumor mass present involving ONE of the following: Extensive lymphadenopathy
(greater than 2 cm) Hepato or splenomegaly palpable on clinical examination Marked bone
marrow infiltration greater than 50% 3) Progressive disease; i.e., increase in IgM
concentration by at least 50%, and/or a drop of greater than 2 g/dL in hemoglobin (in the
absence of gastrointestinal bleeding), and/or a greater than 50,000/mm3 decrease in

PATIENT CHARACTERISTICS: Age: Under 70 Performance status: SWOG 0-2 Life expectancy: Not
specified Hematopoietic: See Disease Characteristics Hepatic: Not specified Renal: Not
specified Cardiovascular: At least 6 months since myocardial infarction No congestive
heart failure No arrhythmia refractory to therapy Ejection fraction within normal range by
MUGA or ECHO Pulmonary: FEV1 at least 50% of predicted DLCO at least 50% of predicted
Other: Not pregnant or nursing Effective contraception required of fertile patients No
significant comorbid condition No uncontrolled life-threatening infection No uncontrolled
diabetes No other malignancy within past 5 years except adequately treated basal or
squamous cell skin cancer, carcinoma in situ of the cervix or adequately treated stage I
or II cancer currently in remission HIV negative Hepatitis B surface antigen negative

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks
since chemotherapy and recovered Endocrine therapy: Not specified Radiotherapy: At least 4
weeks since radiotherapy and recovered Surgery: Not specified

Type of Study:


Study Design:

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

Outcome Measure:

confirmed remission rate

Outcome Time Frame:

until death

Safety Issue:


Principal Investigator

Madhav Dhodapkar, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Rockefeller University


United States: Federal Government

Study ID:




Start Date:

September 1998

Completion Date:

January 2004

Related Keywords:

  • Lymphoma
  • Waldenström macroglobulinemia
  • Lymphoma
  • Waldenstrom Macroglobulinemia



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