Multiple Myeloma Clinical Trial

Umbilical Cord Blood Transplantation From Unrelated Donors

Summary

This study is a single-center, treatment protocol with 4 possible preparative regimens, designed to validate the process of umbilical cord blood stem cell transplantation at our institution.

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Full Description

This study is a single-center treatment protocol with four possible preparative regimens, designed to validate the process of umbilical cord blood stem cell transplantation at our institution. Enrolled patients will receive chemotherapy +/-total body radiation as a pre-transplant conditioning regimen. Patients will then receive cord blood stem cells followed by GvHD prophylaxis that will include Tacrolimus and Mycophenolate Mofetil, or Cyclosporin A and Methylprednisolone. Multiple data points will be collected prior to, during, and following transplantation to ensure safety of the process and to evaluate the stated objectives.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Appropriate diagnosis: Patients must have a disease or syndrome amenable to therapy with hematopoietic stem cell transplantation. Diagnoses include, but are not limited to:
Congenital and Other Non-malignant Disorders:
Immunodeficiency disorders (e.g. Severe Combined Immunodeficiency, Wiskott-Aldrich Syndrome)
Congenital hematopoietic stem cell defects (e.g. Chediak-Higashi Syndrome, Congenital Osteopetrosis, Osteogenesis Imperfecta)
Metabolic disorders (e.g. Hurler's Syndrome)
Severe aplastic anemia
High-Risk Leukemia:
Acute Myelogenous Leukemia

Refractory to standard induction therapy (more than 1 cycle required to achieve remission)

Recurrent (in CR ≥ 2)
Treatment-related AML or MDS
Evolved from myelodysplastic syndrome
Presence of FLT3 abnormalities
FAB M6 or M7
Adverse cytogenetics
Myelodysplastic Syndrome
Acute Lymphoblastic Leukemia including T lymphoblastic leukemia:
Refractory to standard induction therapy (time to CR >4 weeks)
Recurrent (in CR ≥ 2)
WBC count >30,000/mcL at diagnosis
Age >30 at diagnosis
Adverse cytogenetics, such as t(9:22), t(1:19), t(4:11), and other MLL rearrangements.
Chronic Myelogenous Leukemia in accelerated phase or blast crisis
Biphenotypic or undifferentiated leukemia
Burkitt's leukemia or lymphoma
Lymphoma:
Large cell, Mantle cell, Hodgkin lymphoma refractory or recurrent, chemo-sensitive, and ineligible for an autologous stem cell transplant or previously treated with autologous SCT
Marginal zone or follicular lymphoma that is progressive after at least two prior therapies
Multiple Myeloma, recurrent following high-dose therapy and autologous SCT or ineligible for an autologous HSCT
Solid tumors, with efficacy of allogeneic HSCT demonstrated for the specific disease and disease status
Adequate organ function:
Cardiac - LVEF >45%, or shortening fraction >25%, Absence of congestive heart failure or conduction disturbances with high risk for sudden death
Pulmonary - DLCO (corrected for hemoglobin), FEV1 and FVC ≥ 50% predicted;
Renal - serum Cr < 1.5 times the upper limit of normal for age or GFR ≥ 50 ml/min/1.73m2
Hepatic - total bilirubin level < 2 times the upper limit of normal (except for patients with Gilbert's syndrome or hemolysis); if the primary disease process is causal, this criterion will be reconsidered. ALT, AST, and Alkaline phosphatase ≤ 5 times upper limit of normal.
Performance Status Karnofsky or Lansky score ≥ 70%.
Informed Consent must be obtained prior to initiating conditioning therapy.
Receipt of viable cord blood product(s), single or dual, must be confirmed with the stem cell processing laboratory prior to initiating conditioning therapy.

Exclusion Criteria:

Availability of 10/10 or 9/10 HLA-matched related or unrelated donor within a reasonable timeframe dictated by the clinical urgency of the transplant
Autologous HSCT < 6 months prior to proposed UCB transplant
Pregnant or breast feeding
Current uncontrolled infection
Evidence of HIV infection or positive HIV serology

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

30

Study ID:

NCT03016806

Recruitment Status:

Recruiting

Sponsor:

University of Rochester

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There is 1 Location for this study

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Wilmot Cancer Institute
Rochester New York, 14642, United States More Info
Jane L Liesveld, MD
Contact
585-275-4099
[email protected]
Michael W Becker, MD
Contact
585-275-4099
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

30

Study ID:

NCT03016806

Recruitment Status:

Recruiting

Sponsor:


University of Rochester

How clear is this clinincal trial information?

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