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90 Y-BC8-DOTA Monoclonal Antibody, Fludarabine Phosphate, and Total-Body Irradiation Followed By Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Multiple Myeloma

Complete title: A Phase I Study of 90Y-BC8-DOTA monoclonal antibody, Fludarabine and TBI Followed by HLA-Matched, Allogeneic Peripheral Blood Stem Cell Transplant for the Treatment of Multiple Myeloma

Research Study Number       2450.00
    
Principal Investigator       Bill Bensinger, MD
    
Phase       I

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Research Study Description

This phase I trial studies the side effects and best dose of yttrium Y 90 anti-CD45 monoclonal antibody BC8 when given together with fludarabine phosphate and total-body irradiation followed by donor peripheral blood stem cell transplant in treating patients with multiple myeloma. Radiolabeled monoclonal antibodies, such as yttrium Y 90 anti-CD45 monoclonal antibody BC8, can find cancer cells and carry cancer-killing substances to them without harming normal cells. Giving chemotherapy drugs, such as fludarabine phosphate, and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving yttrium Y 90 anti-CD45 monoclonal antibody BC8, fludarabine phosphate, and total-body irradiation before the transplant together with cyclosporine and mycophenolate mofetil after the transplant may stop this from happening and may be an effective treatment for multiple myeloma.

Eligibility Criteria (must meet the following to participate in this study)

Ages Eligible for Study: 18 Years to 65 Years

Genders Eligible for Study: Both

- Patients must have history of symptomatic myeloma requiring treatment (defined as significant anemia [hemoglobin (HgB) less than 10 gm/dl], renal dysfunction [creatinine > 2.0] not attributable to other causes, lytic bone disease on imaging, or hypercalcemia) and meet one of the following requirements:

- * Have at least 1 high risk feature at diagnosis (including deletion 13 or hypodiploidy by conventional cytogenetics, t(4;14), t(14;16) or deletion 17 by fluorescence in situ hybridization [FISH], beta 2 microglobulin > 3.5, lactate dehydrogenase [LDH] greater than 1.5 x upper limit of normal [ULN]) (prior to chemotherapy); OR

- * Have progressive disease on primary therapy with or without prior autologous stem cell transplant; OR

- * Have persistent or progressive disease following autologous transplant; it is acceptable for these patients to have a second transplant for disease reduction

- Bone marrow cellularity of at least 50% of normal by core biopsy (25% cellularity = 50% of normal)

- Eastern Cooperative Oncology Group (ECOG) =< 2

- Measured creatinine clearance > 50 ml/min or estimated creatinine clearance > 50 ml/min

- For females of childbearing potential, must have a negative pregnancy test

- Patients must have an human leukocyte antigen (HLA)-identical sibling donor or an HLA-matched unrelated donor who meets standard Seattle Cancer Care Alliance (SCCA) and or National Marrow Donor Program (NMDP) or other donor center criteria for peripheral blood stem cell (PBSC) donation, as follows:

- * Sibling donor: A patient and sibling donor should be matched for HLA-A, B, C, DRB1 and DQB1 by an intermediate resolution deoxyribonucleic acid (DNA)-based method

- * Unrelated donor: An unrelated donor and recipient should be typed by a high resolution DNA-based method, and ideally matched for HLA-A, B, C, DRB1 and DQB1 alleles, or if there is only a single locus disparity mismatched for an HLA-DQB1 antigen or allele; an unrelated donor may also be mismatched for any single 1) one HLA-A, B or C antigen or allele, or 2) HLA-DRB1 allele (with or without matching for HLA-DQB1)

- Ability to provide informed consent

- DONOR: Patients must have an HLA matched donor as well as standard Seattle Cancer Care Alliance (SCCA) and or National Marrow Donor Program (NMDP)/other donor center criteria for PBSC donation

- DONOR: Donors must consent and be eligible to undergo granulocyte colony-stimulating factor (GCSF) mobilization and PBSC harvest; marrow is not allowed as a source of stem cells on this study

Other eligibility criteria may apply.

Exclusions (conditions that would prevent participation in this study)

- Patients with the following organ dysfunction:

- * Left ventricular ejection fraction < 35%

- * Corrected diffusion capacity of carbon monoxide (DLCO) < 35% or receiving supplemental continuous oxygen

- * Liver abnormalities: fulminant liver failure, cirrhosis of the liver with evidence of portal hypertension, alcoholic hepatitis, esophageal varices, hepatic encephalopathy, uncorrectable hepatic synthetic dysfunction as evidences by prolongation of the prothrombin time, ascites related to portal hypertension, bacterial or fungal liver abscess, biliary obstruction, chronic viral hepatitis, or symptomatic biliary disease

- Pregnant or breast-feeding females

- Circulating antibody against mouse immunoglobulin (HAMA)

- Prior allogeneic transplant

- Plasmacytomas > 1cm in marrow areas measured by magnetic resonance imaging (MRI) or extramedullary plasmacytomas (radiated lesions are exempt from this criteria); patients may receive cytoreductive therapy, including allogeneic stem cell transplant (ASCT) (if high risk) or second ASCT (if failed a prior ASCT) to achieve disease control

- Prior radiation to maximally tolerated levels to any critical normal organ, or > 20 Gy prior radiation to large areas of the bone marrow (e.g., external radiation therapy to whole pelvis)

- Patients who are known to be seropositive for human immunodeficiency virus (HIV)

- Fertile men and women unwilling to use contraceptives during and for 12 months post-transplant

- Active Central Nervous System (CNS) disease at the time of treatment

Other exclusion criteria may apply.



Research Study Number       2450.00
    
Contact       Seattle Cancer Care Alliance Intake Office
    
Telephone       800-804-8824 / 206-288-1024
    
   

Keywords
Hematologic Malignancies; Multiple Myeloma (MM)

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