Rituximab and Cyclophosphamide in Treating Patients With High Risk, Refractory, or Relapsed Multiple Myeloma

Multiple Myeloma and Plasma Cell Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00258206
• Other study ID #: J0478 CDR0000441169
• Secondary ID: P30CA006973JHOC-
• Status: Completed
• Phase: Phase 2
• First received: November 22, 2005
• Last updated: November 1, 2017
• Start date: December 2004
• Est. completion date: September 7, 2007

Study information

• Verified date: November 2017
• Source: Sidney Kimmel Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with cyclophosphamide may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving rituximab together with cyclophosphamide works in treating patients with high risk, refractory, or relapsed multiple myeloma.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: September 7, 2007
• Est. primary completion date: September 7, 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Multiple Myeloma and Plasma Cell Neoplasm
• Neoplasms, Plasma Cell
• Plasmacytoma

Intervention

Biological:
• rituximab

Drug:
• cyclophosphamide

Locations

Country	Name	City	State
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event-free Survival	Percentage of study participants who did not report that their multiple myeloma relapsed or progressed (got worse)	1 year
Primary	Safety of Maintenance Rituximab Following High Dose Cyclophosphamide		2, 3, 6, 9, and 12 months
Secondary	Safety and Toxicity		2, 3, 6, 9, and 12 months
Secondary	Complete Response (CR) Rate and Partial Response (PR) Rate		1 year
Secondary	Effect of Rituximab by Clonogenic Growth of Multiple Myeloma (MM) Progenitors and the Mechanisms by Which MM Stem Cells Are Inhibited		2, 3, 6, 9, and 12 months
Secondary	Overall Survival		5 years