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

November 1, 2017 updated by: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21231-2410
        • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Drug: cyclophosphamide
Other Names:
  • Cytoxan
Biological: rituximab
Other Names:
  • Rituxan

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Carol A. Huff, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Primary Completion (Actual)

September 7, 2007

Study Completion (Actual)

September 7, 2007

Study Registration Dates

First Submitted

November 22, 2005

First Submitted That Met QC Criteria

November 22, 2005

First Posted (Estimate)

November 24, 2005

Study Record Updates

Last Update Posted (Actual)

December 6, 2017

Last Update Submitted That Met QC Criteria

November 1, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • J0478 CDR0000441169
  • P30CA006973 (U.S. NIH Grant/Contract)
  • JHOC-J0478 (Other Identifier: Johns Hopkins SKCCC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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