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OpenTrials
Completed

NCT Number: NCT00258206

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

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Key information

Conditions

Multiple Myeloma and Plasma Cell Neoplasm Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rituximab

Biological

Other names: Rituxan

Cyclophosphamide

Drug

Other names: Cytoxan

Primary outcomes

  1. Event-free Survival

    Time frame: 1 year

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

  2. Safety of Maintenance Rituximab Following High Dose Cyclophosphamide

    Time frame: 2, 3, 6, 9, and 12 months

Secondary outcomes

  1. Safety and Toxicity

    Time frame: 2, 3, 6, 9, and 12 months

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

    Time frame: 1 year

  3. 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

  4. Overall Survival

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Nov 24, 2005
Registry last updated
Dec 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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