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S0115, A Phase II Trial Evaluating Modified High Dose Melphalan (100 mg/m) And Autologous Peripheral Blood Stem Cell Supported Transplant (SCT) For High Risk Patients With Multiple Myeloma And/Or Light Chain Amyloidosis (AL Amyloidosis) (A BMT Study)

Phase 2
18 Years
Open (Enrolling)
Multiple Myeloma, Plasma Cell Myeloma

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Trial Information

S0115, A Phase II Trial Evaluating Modified High Dose Melphalan (100 mg/m) And Autologous Peripheral Blood Stem Cell Supported Transplant (SCT) For High Risk Patients With Multiple Myeloma And/Or Light Chain Amyloidosis (AL Amyloidosis) (A BMT Study)


- Determine overall survival of patients with high-risk multiple myeloma, primary
systemic amyloidosis, or light chain deposition disease treated with two courses of
modified high-dose melphalan and autologous peripheral blood stem cell transplantation.

- Determine the hematologic response in patients treated with this regimen.

- Determine the qualitative and quantitative toxic effects of this regimen in these

- Determine the prognostic significance of cytogenetic markers in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to disease
(high-risk multiple myeloma vs primary systemic amyloidosis vs both).

- Induction therapy (multiple myeloma patients only): Patients receive oral dexamethasone
on days 1-4, 9-12, and 17-20 and oral thalidomide daily on days 1-35. Treatment repeats
every 35 days for 2 courses in the absence of disease progression or unacceptable

- Mobilization and stem cell collection:

- Multiple myeloma patients: Within 28-35 days after completion of induction
therapy, patients receive cyclophosphamide IV over 2-3 hours on day 1 and
filgrastim (G-CSF) subcutaneously (SC) daily beginning on day 2 and continuing
through the day before the last leukapheresis. Usage of mesna IV on day 1 (prior
to and twice after cyclophosphamide administration is recommended).

- Primary systemic amyloidosis patients: Patients receive G-CSF SC daily beginning
on day 1 and continuing through the day before the last leukapheresis.

All patients undergo leukapheresis for the collection of stem cells until the target number
of CD34+ cells is reached.

- Conditioning regimen: Within 1-4 weeks after mobilization, patients receive modified
high-dose melphalan IV over 20 minutes on day -2.

- Peripheral blood stem cell (PBSC) reinfusion: PBSCs are reinfused on day 0. Patients
receive G-CSF SC daily beginning on day 1 and continuing until blood counts recover.

Patients undergo a second autologous PBSC transplantation within 3-6 months, but no later
than 12 months, after the first transplantation.

- Second conditioning regimen: Patients receive modified high-dose melphalan IV over 20
minutes on day -2.

- Second PBSC infusion: PBSCs are infused on day 0.

- Maintenance regimen (multiple myeloma patients only): Between 4-8 weeks after the
second transplantation, patients with no progressive disease receive oral dexamethasone
once daily on days 1-4 and oral thalidomide once daily on days 1-28. Courses repeat
every 28 days for 2 years in the absence of disease progression or unacceptable

Patients are followed at 3 and 6 months and then annually thereafter.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 20-25

Inclusion Criteria


- At least 1 of the following diagnoses:

- Multiple myeloma

- Stage II or III disease

- At least 1 of the following must be present:

- Serum M-protein of IgG, IgA, IgD, IgE greater than 1.0 g/dL

- Urinary M-protein (Bence-Jones) at least 200 mg/24 hours

- No IgM peaks except in patients who have physiologic criteria to support a
diagnosis of multiple myeloma (e.g., bony lesions, myeloma kidney-cast
nephropathy, absence of adenopathy [unless pathology-proven to be plasma
cell infiltration])

- No monoclonal gammopathy of undetermined significance

- No indolent or smoldering myeloma

- No disease progression on prior thalidomide or dexamethasone

- Histologically confirmed primary systemic amyloidosis

- No senile, secondary, localized, dialysis-related, or familial amyloidosis

- No severe cardiac involvement

- No pre-exertional syncope, ventricular arrhythmia, or symptomatic
pleural effusions associated with cardiac involvement

- Light Chain Deposition Disease alone or in combination with multiple myeloma
meeting the following criteria:

- Deposition of granular material containing free light
chains/immunoglobulins that did not bind Congo red

- Evidence of plasma cell dyscrasia (i.e., monoclonal gammopathy in the serum
or urine by immunofixation electrophoresis and/or clonal plasmacytosis) on
bone marrow biopsy by immunohistochemistry and/or elevated serum-free light
chain concentration

- Must have been diagnosed within the past year

- Concurrent enrollment in the myeloma repository protocol SWOG-S0309 must be offered



- 18 and over (patients with amyloidosis only OR patients with amyloidosis and multiple
myeloma OR patients with multiple myeloma only with poor renal function) OR

- 70 and over (patients with multiple myeloma only with or without poor renal function)

Performance status

- Zubrod 0-2

Life expectancy

- Not specified


- Absolute neutrophil count at least 1,000/mm^3

- Platelet count at least 100,000/mm^3


- Bilirubin no greater than 2.5 times upper limit of normal (ULN)

- SGOT or SGPT no greater than 2.5 times ULN


- No hemodialysis within 2 hours of melphalan or stem cell infusion


- See Disease Characteristics

- Hemodynamically stable (i.e., systolic blood pressure > 90 mm Hg in a lying position
within the past 42 days)

- No myocardial infarction within the past 6 months

- No congestive heart failure

- No arrhythmia refractory to medical therapy

- LVEF greater than 45% by echocardiogram or MUGA


- See Disease Characteristics

- No history of chronic obstructive or chronic restrictive pulmonary disease

- Pulmonary function studies (e.g., FEV_1 and FVC) at least 50% of predicted

- DLCO at least 50% of predicted

- Normal high resolution CT scan of the chest and acceptable arterial blood gases
(i.e., PO_2 greater than 70) required for patients unable to complete pulmonary
function tests due to bone pain or fracture


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Multiple myeloma patients receiving thalidomide must use 2 methods of effective
contraception for at least 4 weeks before, during, and for at least 4 weeks
after discontinuation of thalidomide

- HIV negative

- No other concurrent significant medical condition

- No concurrent uncontrolled life-threatening infection

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated
stage I or II cancer currently in complete remission


Biologic therapy

- See Disease Characteristics


- See Disease Characteristics

- Prior cumulative melphalan dose no more than 200 mg

- No other concurrent chemotherapy

Endocrine therapy

- See Disease Characteristics

- No concurrent hormonal therapy


- No concurrent radiotherapy


- Not specified


- Recovered from prior therapy

- Prior or concurrent bisphosphonates allowed

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

5 years

Safety Issue:


Principal Investigator

Vaishali Sanchorawala, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Boston Medical Center


United States: Federal Government

Study ID:




Start Date:

January 2004

Completion Date:

November 2015

Related Keywords:

  • Multiple Myeloma
  • Plasma Cell Myeloma
  • primary systemic amyloidosis
  • stage II multiple myeloma
  • stage III multiple myeloma
  • Amyloidosis
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



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