deltatrials
Completed PHASE1 INTERVENTIONAL NCT00062621

Combined Bone Marrow and Kidney Transplant for Multiple Myeloma With Kidney Failure

Combined HLA-matched Bone Marrow and Kidney Transplantation for Multiple Myeloma With Renal Failure

Sponsor: Immune Tolerance Network (ITN)

Updated 6 times since 2017 Last updated: Feb 1, 2013 Started: Jun 30, 2003 Primary completion: Dec 31, 2006 Completion: Dec 31, 2006
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00062621, this PHASE1 trial focuses on Kidney Failure, Chronic and Multiple Myeloma and remains completed. Sponsored by Immune Tolerance Network (ITN), it has been updated 6 times since 2003, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Study Description(click to expand)

In very limited human testing, a combined kidney and bone marrow transplant appears to be safe and effective in treating multiple myeloma and associated kidney failure. This study will evaluate this approach in 10 patients with kidney failure due to or in association with stage II or greater multiple myeloma. Treatment prior to transplant will include cyclophosphamide, ATGAM (a lymphocyte-specific immunosuppressant), local radiation to the thymus, and cyclosporine (an immunosuppressive drug). An infusion of donor bone marrow and a kidney graft from a closely matched, related donor will be transplanted simultaneously. An additional infusion of donor white blood cells may be administered between day 45 and 74 after transplant in an effort to eliminate any remaining cancer cells. Patients will remain on cyclosporine for a defined period of time. The cyclosporine doses will be slowly decreased and stopped if graft rejection and graft-versus-host disease do not occur. Each participant will be involved in the study for 3 years; this includes the intervention phase (time from initial screening at approximately 7 days before transplant through 100 days after the transplant) and continued follow-up visits for at least 2 years following the transplant.

In very limited human testing, a combined kidney and bone marrow transplant appears to be safe and effective in treating multiple myeloma and associated kidney failure. This study will evaluate this approach in 10 patients with kidney failure due to or in association with stage II or greater multiple myeloma. Treatment prior to transplant will include cyclophosphamide, ATGAM (a lymphocyte-specific immunosuppressant), local radiation to the thymus, and cyclosporine (an immunosuppressive drug).

An infusion of donor bone marrow and a kidney graft from a closely matched, related donor will be transplanted simultaneously. An additional infusion of donor white blood cells may be administered between day 45 and 74 after transplant in an effort to eliminate any remaining cancer cells. Patients will remain on cyclosporine for a defined period of time. The cyclosporine doses will be slowly decreased and stopped if graft rejection and graft-versus-host disease do not occur.

Each participant will be involved in the study for 3 years; this includes the intervention phase (time from initial screening at approximately 7 days before transplant through 100 days after the transplant) and continued follow-up visits for at least 2 years following the transplant.

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

6 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed PHASE1

  2. Sep 2024 — Present [monthly]

    Completed PHASE1

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1

  4. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE1

  5. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE1

Show 1 earlier version
  1. Jan 2017 — Jun 2018 [monthly]

    Completed PHASE1

    First recorded

Jun 2003

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Immune Tolerance Network (ITN)
  • National Institute of Allergy and Infectious Diseases (NIAID)
Data source: National Institute of Allergy and Infectious Diseases (NIAID)

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations