Clinical trial · Interventional
Rituximab, Yttrium Y 90 Ibritumomab Tiuxetan, Melphalan, and Autologous Peripheral Stem Cell Transplant in Treating Patients With Previously Treated Multiple Myeloma
A Phase I Trial of Zevalin Radioimmunotherapy With High-Dose Melphalan and Stem Cell Transplant for 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. Radiolabeled monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan, can find cancer cells and carry cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. A peripheral stem cell transplant using stem cells from the patient may be able to replace blood-forming cells that were destroyed by chemotherapy. Giving monoclonal antibody therapy together with chemotherapy and autologous peripheral stem cell transplant may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of yttrium Y 90 ibritumomab tiuxetan when given together with rituximab, melphalan, and autologous peripheral stem cell transplant in treating patients with previously treated 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 (6)
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Rituximab + Zevalin
- description
- Determine the dose level that is both tolerable and achieves the greatest B cell recovery in patients with multiple myeloma.
- interventionNames
- Biological: rituximab
- Drug: melphalan
- Biological: Stem Cell
- Biological: Sargramostim (GM-CSF)
- Radiation: 90Y-Zevalin
- Biological: 111In Zevalin
Primary outcomes (2)
- measure
- Toxicity as measured by CTCAE v 3.0
- timeFrame
- 19 Months
- measure
- Clonotypic B cells
- timeFrame
- 19 months
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of multiple myeloma * Previously treated disease * Candidate for high-dose chemotherapy with melphalan and autologous stem cell transplantation * No definite evidence of myelodysplasia on pretreatment bone marrow by morphology or by chromosome analysis (e.g., monosomy 7) * Chromosome abnormalities from the myeloma clone allowed PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * ANC ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Bilirubin ≤ 2.0 mg/dL * Alkaline phosphatase ≤ 3 times upper limit of normal (ULN) * AST ≤ 3 times ULN * Creatinine ≤ 2 times ULN * LVEF ≥ 45% * Corrected pulmonary diffusion capacity ≥ 50% * No uncontrolled infection * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other active malignancy (with the exception of nonmelanoma skin cancer) that requires myelosuppressive chemotherapy or radiation therapy * No HIV positivity PRIOR CONCURRENT THERAPY: * More than 3 weeks since prior myelosuppressive chemotherapy, except cyclophosphamide pulsing for stem cell collection) * No other concurrent immunotherapy, radiotherapy, chemotherapy or antimyeloma therapy * Concurrent chronic corticosteroids at doses of prednisone ≤ 20 mg per day (or equivalent) allowed * Concurrent adjuvant hormonal therapy (e.g., tamoxifen citrate or leuprolide acetate) allowed
References
Publications (0)
Data not yet available