NCT00062621

Brief Summary

The purpose of this study is to determine whether a combined bone marrow and kidney transplant will be effective in treating stage II or greater multiple myeloma and associated kidney failure. This study will determine whether transplant rejection and the need for immunosuppressive drugs are decreased with this combined transplant approach.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2003

Typical duration for phase_1

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

June 1, 2003

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

June 9, 2003

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 12, 2003

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

February 5, 2013

Status Verified

February 1, 2013

Enrollment Period

3.5 years

First QC Date

June 9, 2003

Last Update Submit

February 1, 2013

Conditions

Kidney Failure, ChronicMultiple Myeloma

Keywords

Immune toleranceGraft vs host diseaseKidney FailureKidney diseasesEnd Stage Renal DiseaseMultiple MyelomaBone Marrow TransplantKidney TransplantRenal TransplantToleranceChimerismESRD

Outcome Measures

Primary Outcomes (2)

  • Remission status of multiple myeloma

    Throughout study

  • Renal allograft acceptance and ability to discontinue immunosuppressive therapy

    Throughout study

Secondary Outcomes (3)

  • Graft vs. host disease (GVHD)

    Throughout study

  • Opportunistic infections

    Throughouto study

  • T-cell recovery and immune reconstitution

    Throughout study

Interventions

Combined bone marrow and kidney transplantPROCEDURE

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • End-stage renal disease (ESRD) due to or in association with stage II or greater multiple myeloma
  • Participants in whom the development of ESRD is not due to the underlying myeloma will be included if they have evidence of active myeloma despite past treatment with standard therapies (e.g., prednisone, melphalan, high-dose radiation therapy with autologous stem cell transplantation)
  • On dialysis or have a creatinine clearance greater than 20 ml/min
  • HLA-matched or one of six HLA antigen-mismatched related donor

You may not qualify if:

  • Compromised pulmonary, cardiac, or liver function
  • Active infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114-2696, United States

Location

Related Links

MeSH Terms

Conditions

Kidney Failure, ChronicMultiple MyelomaGraft vs Host DiseaseRenal InsufficiencyKidney Diseases

Interventions

Kidney Transplantation

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Renal Replacement TherapyTherapeuticsOrgan TransplantationTransplantationSurgical Procedures, OperativeUrologic Surgical ProceduresUrogenital Surgical Procedures

Study Officials

  • Thomas Spitzer, MD

    Massachussetts General Hospital

    PRINCIPAL INVESTIGATOR

  • A. Benedict Cosimi, MD

    Massachussetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2003

First Posted

June 12, 2003

Study Start

June 1, 2003

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

February 5, 2013

Record last verified: 2013-02

Locations

US(1)