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

NCT00258206 | Completed Phase 2 Results

• 3 other identifiers: J0478 CDR0000441169P30CA006973JHOC-J0478
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Event-free Survival

  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

  2, 3, 6, 9, and 12 months

Secondary Outcomes (4)

• 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

Study Arms (1)

rituximab + cyclophosphamide

EXPERIMENTAL

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

Biological: rituximab; Drug: cyclophosphamide

Interventions

rituximab BIOLOGICAL

Also known as: Rituxan

rituximab + cyclophosphamide

cyclophosphamide DRUG

Also known as: Cytoxan

rituximab + cyclophosphamide

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell

Interventions

Rituximab; Cyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Results Point of Contact

• Title: Dr. Carol Ann Huff
• Organization: Johns Hopkins University

chuff1@jhmi.edu

410-955-8842

Study Officials

• Carol A. Huff, MD

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2005
• First Posted: November 24, 2005
• Study Start: December 1, 2004
• Primary Completion: September 7, 2007
• Study Completion: September 7, 2007
• Last Updated: December 6, 2017
• Results First Posted: June 11, 2015

Record last verified: 2017-11

Locations

US (1)