deltatrials
Completed PHASE1/PHASE2 INTERVENTIONAL 1-arm NCT00369226

Bortezomib Plus Tacrolimus and Methotrexate to Prevent Graft Versus Host Disease (GVHD) After Mismatched Allogeneic Non-Myeloablative Blood Stem Cell Transplantation

Phase I/II Trial of Bortezomib (Velcade) in Addition to Tacrolimus and Methotrexate to Prevent Graft Versus Host Disease (GVHD) After Mismatched Allogeneic Non-Myeloablative Peripheral Blood Stem Cell Transplantation

Sponsor: Brigham and Women's Hospital

Updated 9 times since 2017 Last updated: Jun 19, 2013 Started: Aug 31, 2006 Primary completion: Jul 31, 2010 Completion: Sep 30, 2011
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE1/PHASE2 clinical study on Hematologic Malignancies, this trial is completed. The trial is conducted by Brigham and Women's Hospital and has accumulated 9 data snapshots since 2006. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Study Description(click to expand)

* In this study we are looking for the highest dose of Velcade that can be given to people safely when given with tacrolimus and methotrexate. Not everyone who participates in the study will receive the same amount of the study drug. The dose the participant will receive depends upon the number of subjects enrolled on the study and how well they have tolerated their doses of the drug. * Before Transplant: In addition to the chemotherapy drugs, fludarabine and busulfex, for the participants non-myeloablative transplant, they will also start taking tacrolimus orally three days before their transplant. * After Transplant Medication: Methotrexate; Intravenously on days 1, 3, 6 \& 11 after transplant for a total of 4 doses. Tacrolimus; Continue taking orally once daily. Velcade: Intravenously on days 1, 4 \& 7 after transplant, a total of 3 doses. Filgrastim: Subcutaneous injection daily starting the day after transplant and continuing until the participant blood counts have recovered. * After Transplant Physical Exams \& Tests: Participants will have physical exams and blood tests every week for 1 month. After 1 month, a none marrow biopsy will be performed to look for evidence of the donor's cells in the participants bone...

* In this study we are looking for the highest dose of Velcade that can be given to people safely when given with tacrolimus and methotrexate. Not everyone who participates in the study will receive the same amount of the study drug. The dose the participant will receive depends upon the number of subjects enrolled on the study and how well they have tolerated their doses of the drug. * Before Transplant: In addition to the chemotherapy drugs, fludarabine and busulfex, for the participants non-myeloablative transplant, they will also start taking tacrolimus orally three days before their transplant. * After Transplant Medication: Methotrexate; Intravenously on days 1, 3, 6 \& 11 after transplant for a total of 4 doses. Tacrolimus; Continue taking orally once daily. Velcade: Intravenously on days 1, 4 \& 7 after transplant, a total of 3 doses. Filgrastim: Subcutaneous injection daily starting the day after transplant and continuing until the participant blood counts have recovered. * After Transplant Physical Exams \& Tests: Participants will have physical exams and blood tests every week for 1 month. After 1 month, a none marrow biopsy will be performed to look for evidence of the donor's cells in the participants bone marrow. * Following the 1 month period of time, participants will be seen every few weeks. Another bone marrow biopsy, as well as blood tests, will be taken 3-4 months after the transplant to review the disease status. At this point, participants will come into the clinic about every 3 months, or as determined by their physician for about one year. * While the study ends at 12 months after transplant, we would like to keep track of the participants medical condition for the rest of their life.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotCompleted~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Dec 2022 · 23 months · monthly snapshotCompleted~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshotCompleted~Jan 2023 – ~Jul 2024 · 18 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

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

    Completed PHASE1/PHASE2

  2. Sep 2024 — Present [monthly]

    Completed PHASE1/PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1/PHASE2

    Phase: PHASE1_PHASE2PHASE1/PHASE2

  4. Jan 2023 — Jul 2024 [monthly]

    Completed PHASE1_PHASE2

  5. Dec 2022 — Jan 2023 [monthly]

    Completed PHASE1_PHASE2

Show 4 earlier versions
  1. Jan 2021 — Dec 2022 [monthly]

    Completed PHASE1_PHASE2

  2. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE1_PHASE2

  3. Feb 2017 — Jun 2018 [monthly]

    Completed PHASE1_PHASE2

  4. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE1_PHASE2

    First recorded

Aug 2006

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Brigham and Women's Hospital
  • Dana-Farber Cancer Institute
  • Millennium Pharmaceuticals, Inc.
Data source: Dana-Farber Cancer Institute

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

Study Locations