TriangleNCT00258206 · REGISTRY CONDITION SEARCH
Rituximab and Cyclophosphamide in Treating Patients With High Risk, Refractory, or Relapsed Multiple Myeloma
Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.
- Phase
- PHASE2
- Status at capture
- COMPLETED
- Registry last update
- 2017-12-06
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.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Event-free Survival
Safety of Maintenance Rituximab Following High Dose Cyclophosphamide
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
Adverse events
Limitations, agreements, and source contact
Who could take part
- 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
- healthy Volunteers
- false
- maximum Age
- 120 Years
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- 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 Names
- Biological: rituximab
- Drug: cyclophosphamide
- label
- rituximab + cyclophosphamide
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- rituximab + cyclophosphamide
- name
- rituximab
- other Names
- Rituxan
- type
- BIOLOGICAL
- arm Group Labels
- rituximab + cyclophosphamide
- name
- cyclophosphamide
- other Names
- Cytoxan
- type
- DRUG
Study design
- allocation
- NA
- intervention Model
- SINGLE_GROUP
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 21
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- Percentage of study participants who did not report that their multiple myeloma relapsed or progressed (got worse)
- measure
- Event-free Survival
- time Frame
- 1 year
- measure
- Safety of Maintenance Rituximab Following High Dose Cyclophosphamide
- time Frame
- 2, 3, 6, 9, and 12 months
- secondary Outcomes
- measure
- Safety and Toxicity
- time Frame
- 2, 3, 6, 9, and 12 months
- measure
- Complete Response (CR) Rate and Partial Response (PR) Rate
- time Frame
- 1 year
- measure
- 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
- measure
- Overall Survival
- time Frame
- 5 years
Full 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.
Source references
Source notices and limitations
Discovery and provenance
- release id
- ctgov-registry-1336d216cbd1bbff780dac70
- edge id
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- payload
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- link basis
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- occurrences
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- end
- 11
- exact text
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- start
- 0
- offset unit
- unicode_code_points
- query cond
- Plasma Cell Neoplasms
- query disease state id
- ds-plasma-cell-neoplasms
- source file
- /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-plasma-cell-neoplasms-000.json
- source file sha256
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- source json pointer
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- source kind
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- source record id
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- source string basis
- parsed_JSON_string_unmodified
- source string sha256
- 9d396ec1d7b7dbfb3b0194176a1264839ef2747a614861d71e9fe606142f6ef4
Preserved source evidence · Not medical advice