Phase I Study of Sequential Cord Blood Transplants

Multiple Myeloma Clinical Trial

Official title:

Phase I Study of Sequential Cord Blood Transplants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00299767
• Other study ID #: 03-061
• Status: Completed
• Phase: Phase 1
• First received: March 3, 2006
• Last updated: May 9, 2016
• Start date: May 2003
• Est. completion date: May 2009

Study information

• Verified date: May 2016
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the safety of sequential cord blood transplantation (2 cord blood units) for patients who have diseases that are capable of being cured by allogeneic stem cell transplant but do not have a matched family or volunteer unrelated donor.

Description:

Eligible patients will receive conditioning therapy with fludarabine 30 mg/m2/day x 6 days, melphalan 100 mg/m2/day x 1 day, rabbit antithymocyte globulin 1.5 mg/kg/day x 4 days. GVHD prophylaxis will consist of cyclosporine starting on day -1 and mycophenolate mofetil starting on day 0. Sequential cord blood units will be infused on Day 0.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: May 2009
• Est. primary completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 65 Years

Eligibility

Inclusion Criteria:

• Disease Status: NHL, HD, or MM refractory to chemotherapy or relapsed; CLL Rai Stage III/IV, or lymphocyte doubling time of 6 months, or Stage I/II resistant to 2 chemotherapy regimens; AML or ALL in second or subsequent remission or in first remission with adverse cytogenetics or antecedent hematologic disorder

• Estimated disease-free survival of less than one year

• ECOG performance status of 0, 1, 2

• Lack of 6/6 or 5/6 HLA matched related or 6/6 matched unrelated donor, or a donor is not available within the time frame necessary to perform a potentially curative stem cell transplant

• 4/6 or greater HLA A, B, CRB1 cord blood units with a combined nucleated cell dose from of > 3.7 x 10(7) NC/kg

Exclusion Criteria:

• Cardiac disease: symptomatic congestive hearth failure or RVG or echocardiogram determined left ventricular ejection fraction of < 45%, active angina pectoris, or uncontrolled hypertension

• Pulmonary Disease: severe chronic obstructive lung disease, or symptomatic restrictive lung disease, or corrected DLCO of < 50%

• Renal disease: serum creatinine > 2.0 mg/dl

• Hepatic disease: serum bilirubin > 2.0 mg/dl (except in the case of Gilbert's syndrome), SGPT or SGOT > 3 x normal

• Neurologic disease: symptomatic leukoencephalopathy, active DNS malignancy or other neuropsychiatric abnormalities believed to preclude transplantation

• HIV antibody or Hepatitis B surface antigen positivity

• Uncontrolled infection

• Pregnancy or breast-feeding mother

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Lymphoma
• Multiple Myeloma
• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Preleukemia

Intervention

Procedure:
• sequential cord blood transplantation
Infused on Day 0

Locations

Country	Name	City	State
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the 100-day transplant-related (non-relapse) mortality, including relapse-related mortality associated with Grade 4 toxicity.		3 years	Yes
Secondary	To evaluate the 6 month transplant related (non-relapse) mortality.		3 years	No
Secondary	To evaluate the days to neutrophil engraftment (ANC > 500).		3 years	No
Secondary	To evaluate the days of platelet engraftment (platelet count > 20K unsupported).		3 years	No
Secondary	To evaluate the risk of acute and chronic graft versus host disease.		3 years	Yes
Secondary	To evaluate percent donor chimerism - contribution of each cord unit.		3 years	No
Secondary	To evaluate relapse rate.		TBD	No
Secondary	To evaluate overall survival.		TBD	No
Secondary	To evaluate transfusion support needed to cord blood transplant recipients.		3 years	Yes