Know Cancer

or
forgot password

A Phase II Study Of Blood Stem Cell Mobilization With Intravenous Melphalan (60 MG/M2) + G-CSF In Patients With Multiple Myeloma


Phase 2
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma and Plasma Cell Neoplasm

Thank you

Trial Information

A Phase II Study Of Blood Stem Cell Mobilization With Intravenous Melphalan (60 MG/M2) + G-CSF In Patients With Multiple Myeloma


OBJECTIVES:

- Determine the safety and efficacy of melphalan when used with filgrastim (G-CSF) for
stem cell mobilization in patients with multiple myeloma.

- Analyze how this mobilization regimen affects parameters of stem cell (CD34+)
mobilization and collection in these patients.

- Determine how this mobilization regimen affects disease status and clonotypic (i.e.,
tumor cell) contamination in stem cell components in these patients.

OUTLINE: Patients undergo peripheral blood stem cell (PBSC) mobilization consisting of
melphalan IV on day 1 and filgrastim (G-CSF) subcutaneously beginning on day 2 and
continuing until PBSC collection is complete.

Patients are followed at 1 month.

PROJECTED ACCRUAL: A total of 11-32 patients will be accrued for this study within 2 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of multiple myeloma

- Must have received induction therapy within the past 3 months

- Chemoresponsive disease

- Greater than 50% reduction of monoclonal paraprotein with reduction in marrow
plasma cell infiltrate or greater than 50% reduction in marrow plasma cell
infiltrate if disease is non-secretory

- No symptomatic pleural effusions

- Eligible for stem cell transplantation

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-3 (ECOG 3 allowed only if due to bone disease or neuropathy)

Life expectancy:

- Not specified

Hematopoietic:

- Platelet count at least 150,000/mm^3

Hepatic:

- Bilirubin no greater than 2.5 mg/dL

Renal:

- Creatinine no greater than 2.5 mg/dL OR

- Creatinine clearance greater than 51 mL/min

Cardiovascular:

- No symptomatic cardiomyopathy

- No medically documented symptomatic cardiac arrhythmias within the past 60 days

- No New York Heart Association class III congestive heart failure

- No myocardial infarction within the past 6 months

Other:

- No other concurrent medical conditions that would preclude study

- No uncontrolled infections

- No other active malignancy within the past 5 years except for non-melanoma skin
cancer

- Not pregnant

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No prior stem cell mobilization or transplantation

Chemotherapy:

- See Disease Characteristics

- No more than 200 mg prior oral melphalan

Endocrine therapy:

- Not specified

Radiotherapy:

- No more than 3000 cGy of prior radiotherapy for myeloma

Surgery:

- Not specified

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Raymond L. Comenzo, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

00-067

NCT ID:

NCT00008268

Start Date:

August 2000

Completion Date:

June 2003

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

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021