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

NCT ID: NCT00258206

Last Updated: 2017-12-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2007-09-07

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Multiple Myeloma and Plasma Cell Neoplasm

Keywords

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stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma refractory multiple myeloma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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rituximab + cyclophosphamide

Rituximab 375 mg/m\^2 on Days -10 and -7; Cyclophosphamide 50 mg/kg on days -3, -2, -1, and 0; Rituximab 375 mg/m\^2 weekly x4 after platelet counts recover; For patients achieving at least stable disease, rituximab maintenance 375 mg/m\^2 once each during months 3, 6, 9, and 12

Group Type EXPERIMENTAL

rituximab

Intervention Type BIOLOGICAL

cyclophosphamide

Intervention Type DRUG

Interventions

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rituximab

Intervention Type BIOLOGICAL

cyclophosphamide

Intervention Type DRUG

Other Intervention Names

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Rituxan Cytoxan

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carol A. Huff, MD

Role: STUDY_CHAIR

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Locations

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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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P30CA006973

Identifier Type: NIH

Identifier Source: secondary_id

View Link

JHOC-J0478

Identifier Type: OTHER

Identifier Source: secondary_id

J0478 CDR0000441169

Identifier Type: -

Identifier Source: org_study_id