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

Phase 2

Completed

• Conditions: Multiple Myeloma and Plasma Cell Neoplasm
• Interventions: Biological: rituximab; Drug: cyclophosphamide

• Registration Number: NCT00258206
• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2004-12
• Study First Submitted: 2005-11-22
• Study First Submitted QC: 2005-11-22
• Study First Posted: 2005-11-24
• Primary Completion: 2007-09-07
• Study Completion: 2007-09-07
• Results First Submitted: 2015-05-28
• Results First Submitted QC: 2015-05-28
• Results First Posted: 2015-06-11
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-01
• Last Update Posted: 2017-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
rituximab + cyclophosphamide	rituximab	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
rituximab + cyclophosphamide	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

Primary Outcome Measures

Name	Time	Method
Event-free Survival	1 year	Percentage of study participants who did not report that their multiple myeloma relapsed or progressed (got worse)
Safety of Maintenance Rituximab Following High Dose Cyclophosphamide	2, 3, 6, 9, and 12 months

Secondary Outcome Measures

Name	Time	Method
Safety and Toxicity	2, 3, 6, 9, and 12 months
Complete Response (CR) Rate and Partial Response (PR) Rate	1 year
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
Overall Survival	5 years

Trial Locations

Locations (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States