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

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

rituximab

cyclophosphamide

About this trial

This is an interventional treatment trial for Multiple Myeloma and Plasma Cell Neoplasm focused on measuring stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, refractory multiple myeloma

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

rituximab + cyclophosphamide

Arm Description

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

Outcomes

Primary Outcome Measures

Event-free Survival

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

Secondary Outcome Measures

Safety and Toxicity

Complete Response (CR) Rate and Partial Response (PR) Rate

Effect of Rituximab by Clonogenic Growth of Multiple Myeloma (MM) Progenitors and the Mechanisms by Which MM Stem Cells Are Inhibited

Overall Survival

Full Information

NCT ID

NCT00258206

First Posted

November 22, 2005

Last Updated

November 1, 2017

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00258206

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Completed

Study Start Date

December 2004 (undefined)

Primary Completion Date

September 7, 2007 (Actual)

Study Completion Date

September 7, 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Myeloma and Plasma Cell Neoplasm

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

rituximab + cyclophosphamide

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

rituximab

Other Intervention Name(s)

Rituxan

Intervention Type

Drug

Intervention Name(s)

cyclophosphamide

Other Intervention Name(s)

Cytoxan

Primary Outcome Measure Information:

Title

Event-free Survival

Description

Percentage of study participants who did not report that their multiple myeloma relapsed or progressed (got worse)

Time Frame

1 year

Title

Safety of Maintenance Rituximab Following High Dose Cyclophosphamide

Time Frame

2, 3, 6, 9, and 12 months

Secondary Outcome Measure Information:

Title

Safety and Toxicity

Time Frame

2, 3, 6, 9, and 12 months

Title

Complete Response (CR) Rate and Partial Response (PR) Rate

Time Frame

1 year

Title

Effect of Rituximab by Clonogenic Growth of Multiple Myeloma (MM) Progenitors and the Mechanisms by Which MM Stem Cells Are Inhibited

Time Frame

2, 3, 6, 9, and 12 months

Title

Overall Survival

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

120 Years

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Carol A. Huff, MD

Organizational Affiliation

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Official's Role

Study Chair

Facility Information:

Facility Name

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21231-2410

Country

United States

Multiple Myeloma and Plasma Cell Neoplasm

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial