NCT00427557

Brief Summary

The goal of this clinical research study is to learn if giving umbilical cord blood along with standard stem cells after high-dose chemotherapy will improve the response to a stem cell transplant. The safety of this treatment will also be studied.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for phase_2 multiple-myeloma

Timeline
Completed

Started Oct 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 29, 2007

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

May 17, 2012

Completed
Last Updated

May 28, 2012

Status Verified

May 1, 2012

Enrollment Period

4.1 years

First QC Date

January 25, 2007

Results QC Date

April 19, 2012

Last Update Submit

May 23, 2012

Conditions

Multiple MyelomaLeukemiaLymphoma

Keywords

Multiple MyelomaAcute Myeloid LeukemiaMyelodysplastic SyndromeAcute Lymphoblastic LeukemiaNon-Hodgkin's LymphomaHodgkin's LymphomaChronic Lymphocytic LeukemiaCellular TherapyUmbilical Cord Blood CellsCord Blood TransplantationStem CellsStem Cell TransplantationAllogeneicHematopoietic Stem Cell TransplantationGraft vs. Host DiseaseGVDFludarabineFludarabine PhosphateFludaraMelphalanRituximabRituxanLeukemiaLymphoma

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Engraftment

    Engraftment defined as first of three (3) consecutive days with Absolute neutrophil count (ANC) equal to or more than 0.5 \* 10\^9/L; assessed from baseline to 100 days post-engraftment.

    Baseline to 100 days post-engraftment

Study Arms (1)

Cellular Therapy with Cord Blood Cells

EXPERIMENTAL

Fludarabine 30 mg/m\^2 intravenous (IV) for 4 Days + Melphalan 140 mg/m\^2 IV for 1 Day + Rituximab 375 mg/m\^2 IV once weekly + Cord Blood Transplantation + Stem Cell Transplantation Infusion

Drug: FludarabineDrug: MelphalanProcedure: Umbilical Cord BloodDrug: RituximabOther: Peripheral Blood Stem Cell Infusion

Interventions

FludarabineDRUG

30 mg/m\^2 by vein for 4 Days (Day -10 through Day -7).

Also known as: Fludara, Fludarabine Phosphate
Cellular Therapy with Cord Blood Cells
MelphalanDRUG

140 mg/m\^2 by vein for 1 Day (Day -7).

Cellular Therapy with Cord Blood Cells
Umbilical Cord BloodPROCEDURE

1 UCB Unit by vein on Day -5.

Also known as: UCB
Cellular Therapy with Cord Blood Cells
RituximabDRUG

375 mg/m\^2 by vein once weekly (Days -7, -1, +7, +14) for 4 Weeks (if appropriate).

Also known as: Rituxan
Cellular Therapy with Cord Blood Cells
Peripheral Blood Stem Cell InfusionOTHER

Infusion of blood stem cells on Day 0.

Also known as: SCT, Stem Cell Transplant, Allogeneic Hematopoietic Stem Cell Transplantation, AHSCT
Cellular Therapy with Cord Blood Cells

Eligibility Criteria

AgeUp to 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with multiple myeloma (MM), acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), acute lymphoblastic leukemia (ALL), non-Hodgkin's lymphoma (NHL), Hodgkin's lymphoma (HL), or chronic lymphocytic leukemia (CLL) in greater than first complete remission who are candidates for a non-ablative or reduced intensity conditioning regimen.
  • Age up to 80 years.
  • A related or unrelated donor who is HLA-matched at HLA, A, B, C, DR and DQ loci is acceptable (i.e. 10/10 matched related or unrelated donor, matched with molecular high-resolution technique per current standard for the BMT program). Donor must be willing to donate peripheral blood or bone marrow progenitor cells.
  • Available cord blood unit must contain a minimum of 1.5 \* 10\^7 total nucleated cells per kg, and be at least a 4/6 HLA match with patient.
  • Zubrod PS less than or equal to 2 or Lansky PS greater than or equal to 50%.
  • Left ventricular ejection fraction \>40%. No uncontrolled arrhythmias or symptomatic heart disease.
  • Forced Expiratory Volume in 1 second (FEV1), Forced Vital Capacity (FVC) and Diffusion Capacity (DLCO) \>40%.
  • Serum creatinine \<2.0 mg/dL. Serum bilirubin \<3 \* upper limit of normal, SGPT \<4 \* upper limit of normal.

You may not qualify if:

  • Patients with active CNS disease
  • Positive Beta HCG in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization.
  • Serious medical or psychiatric illness likely to interfere with participation in this clinical study, including but not limited to active uncontrolled infection, uncontrolled cardiac arrhythmia or ischemic event, or uncontrolled psychosis, major depression, or mania.
  • Evidence of chronic, active hepatitis or cirrhosis, or HIV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Multiple MyelomaLeukemiaLymphomaLeukemia, Myeloid, AcuteMyelodysplastic SyndromesPrecursor Cell Lymphoblastic Leukemia-LymphomaLymphoma, Non-HodgkinHodgkin DiseaseLeukemia, Lymphocytic, Chronic, B-CellGraft vs Host Disease

Interventions

fludarabinefludarabine phosphateMelphalanRituximabStem Cell Transplantation

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesLymphatic DiseasesLeukemia, MyeloidBone Marrow DiseasesLeukemia, LymphoidLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsAntibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsSerum GlobulinsGlobulinsCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Results Point of Contact

Title
Dr. Partow Kebriaei
Organization
MD Anderson Cancer Center
celsaenz@mdanderson.org
713-563-5174

Study Officials

  • Partow Kebriaei, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2007

First Posted

January 29, 2007

Study Start

October 1, 2006

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

May 28, 2012

Results First Posted

May 17, 2012

Record last verified: 2012-05

Locations

US(1)