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P021

Peptide 021, GLXC-21260

Quick Stats
Studies 37
Trials 57
Completed PHASE1 INTERVENTIONAL NCT00477815

Rituximab, Yttrium Y 90 Ibritumomab Tiuxetan, Melphalan, and Autologous Peripheral Stem Cell Transplant in Treating Patients With Previously Treated Multiple Myeloma

View on ClinicalTrials.gov Updated Dec 15, 2025

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. 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.

Detailed Description

OBJECTIVES: Primary * Determine the safety of rituximab, yttrium Y 90 ibritumomab tiuxetan, high-dose melphalan, and autologous peripheral blood stem cell transplantation in patients with previously treated multiple myeloma. * Determine the effect of rituximab and yttrium Y 90 ibritumomab tiuxetan on the clonotypic B-cells at baseline and at B-cell recovery in these patients. Secondary * Determine the response rate and progression factors (time to progression, progression-free survival, and duration of response) in patients treated with this regimen. * Determine the effect of rituximab and yttrium Y 90 ibritumomab tiuxetan on the clonal plasma cells in the blood and marrow prior to high-dose melphalan. OUTLINE: This is a dose-escalation study of yttrium Y 90 ibritumomab tiuxetan. Patients receive rituximab IV followed by a dosimetry dose of indium In 111 ibritumomab tiuxetan IV over 10 minutes on day -22. Patients with acceptable biodistribution receive rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day -14, high-dose melphalan IV over 1 hour on days -2 and -1, and undergo autologous peripheral blood stem cell transplantation on day 0. Patients also receive sargramostim (GM-CSF) subcutaneously beginning on day 0 and continuing until blood counts recover. Cohorts of 3-6 patients receive escalating doses of yttrium Y 90 ibritumomab tiuxetan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Bone marrow, blood, and urine samples are collected at baseline and then periodically during study for biomarker correlative studies. After completion of study treatment, patients are followed every 3 months for 5 years.

Interventions

Name: rituximab
Type: BIOLOGICAL
Description: 375 mg/m2 given as an IV infusion once weekly for four doses (days 1, 8, 15, and 22)
Name: melphalan
Type: DRUG
Description: 100/m2 in 1000 ml 0.9% NaCI IV infusion over 1 hour daily x 2 days.
Name: Stem Cell
Type: BIOLOGICAL
Description: greater than or equal to 2 x 106 CD34+/kg by IV
Name: Sargramostim (GM-CSF)
Type: BIOLOGICAL
Description: 500 mcg by Subcutaneous QD
Name: 90Y-Zevalin
Type: RADIATION
Description: Dose escalation scheme. The dose of Zevalin will be based on the calculated radiation to the liver.
Name: 111In Zevalin
Type: BIOLOGICAL
Description: 5.0 mCi by IV

Primary Outcomes

Measure: Toxicity as measured by CTCAE v 3.0
TimeFrame: 19 Months
Description:
Measure: Clonotypic B cells
TimeFrame: 19 months
Description:

Trial Information

NCT ID

NCT00477815

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE1

Sponsor

Mayo Clinic

Last Updated

December 15, 2025