Clinical trial · Interventional
Rituximab and Cyclophosphamide in Treating Patients With High Risk, Refractory, or Relapsed Multiple Myeloma
Phase II Study of High Dose Cyclophosphamide and Rituximab in Multiple Myeloma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma and Plasma Cell Neoplasm | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| rituximab | Biological | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- rituximab + cyclophosphamide
- 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
- interventionNames
- Biological: rituximab
- Drug: cyclophosphamide
Primary outcomes (2)
- measure
- Event-free Survival
- timeFrame
- 1 year
- description
- Percentage of study participants who did not report that their multiple myeloma relapsed or progressed (got worse)
- measure
- Safety of Maintenance Rituximab Following High Dose Cyclophosphamide
- timeFrame
- 2, 3, 6, 9, and 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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 therapyReferences
Publications (0)
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