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Phase II Study of High Dose Cyclophosphamide and Rituximab in Multiple Myeloma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma and Plasma Cell Neoplasm

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Trial Information

Phase II Study of High Dose Cyclophosphamide and Rituximab in Multiple Myeloma


OBJECTIVES:

- Determine the effect of rituximab and high-dose cyclophosphamide on the growth of
myeloma stem cells in patients with high-risk, refractory, or relapsed multiple
myeloma.

OUTLINE: Patients receive rituximab IV on days -10 and -7; once weekly for 4 weeks (after
completion of high-dose cyclophosphamide); and then once in months 3, 6, 9, and 12. Patients
also receive high-dose cyclophosphamide on days -3 to 0.

PROJECTED ACCRUAL: Not specified.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of multiple myeloma, meeting 1 of the following criteria:

- High-risk disease in first remission, as defined by the following:

- Beta-2 microglobulin > 5.0 mg/dL

- Chromosome 13 deletion

- Primary refractory disease

- Relapsed disease after achieving a response to prior chemotherapy

- The following diagnoses are not allowed:

- POEMS syndrome

- Plasma cell leukemia

- Amyloidosis

- Nonsecretory myeloma

- No evidence of spinal cord compression

PATIENT CHARACTERISTICS:

Age

- Over 18

Performance status

- Not specified

Life expectancy

- Not specified

Hematopoietic

- Not specified

Hepatic

- Not specified

Renal

- Not specified

Other

- Not pregnant or nursing

- Fertile patients must use effective contraception

- HIV negative

- Has good organ function

- Is in good physical condition

- No active infection requiring antibiotics

- No other malignancy within the past 2 years except basal cell or squamous cell skin
cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No persistently detectable donor cells after prior allogeneic stem cell
transplantation

- No prior rituximab

Chemotherapy

- See Disease Characteristics

Endocrine therapy

- Not specified

Radiotherapy

- Not specified

Surgery

- Not specified

Other

- At least 28 days since prior therapy

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Event-free survival at 1 year

Safety Issue:

No

Principal Investigator

Carol A. Huff, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

J0478 CDR0000441169

NCT ID:

NCT00258206

Start Date:

December 2004

Completion Date:

Related Keywords:

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

Name

Location

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410