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

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT00477815
Phase
PHASE1
Status
Completed

Conditions

  • Multiple Myeloma and Plasma Cell Neoplasm

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
May 31, 2005
Status verified
May 2018
Primary completion
Jul 28, 2011
Completion
May 7, 2018

Study Design

Enrollment
30 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Rituximab + Zevalin
    Determine the dose level that is both tolerable and achieves the greatest B cell recovery in patients with multiple myeloma.

Primary Outcome Measure

Toxicity as measured by CTCAE v 3.0 [ Time Frame: 19 Months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo ClinicRochesterMinnesota55905-

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By research site
Mayo Clinic· Rochester, MN

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