Bortezomib Before Donor Stem Cell Transplant in Treating Patients With Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT00995059|
Recruitment Status : Withdrawn
First Posted : October 14, 2009
Last Update Posted : April 19, 2016
Rationale: Giving bortezomib and low doses of chemotherapy and total-body irradiation before a donor stem cell transplant or peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving sirolimus and tacrolimus before and after transplant may stop this from happening.
Purpose: This phase I/II trial is studying the side effects and best dose of bortezomib before donor stem cell transplant in treating patients with multiple myeloma.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma Refractory Multiple Myeloma||Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation Procedure: allogeneic bone marrow transplantation Drug: bortezomib Drug: melphalan Drug: anti-thymocyte globulin Drug: sirolimus Drug: tacrolimus Radiation: total-body irradiation||Phase 1 Phase 2|
I. To determine the maximum tolerated dose (MTD) of bortezomib when used in a novel conditioning regimen for patients undergoing allogeneic stem cell transplantation for multiple myeloma.
II. To evaluate the tolerability and feasibility of this novel conditioning regimen and GVHD prophylaxis strategy incorporating several anti-myeloma agents, including bortezomib, in patients undergoing allogeneic stem cell transplantation for multiple myeloma.
III. To obtain an initial assessment of the efficacy of this novel conditioning regimen.
Outline: This is a phase I dose-escalation study of bortezomib followed by a phase II study.
Reduced-Intensity Conditioning: Patients receive bortezomib IV and then undergo fractionated total-body irradiation on days -5 and -2. Patients receive thymoglobulin IV over 6 hours on days -5 to -2 and melphalan IV over 30 minutes on days -4 to -3.
Allogenic Stem Cell Transplantation: Patients undergo bone marrow or peripheral blood stem cell transplant on day 0.
Graft versus Host Disease Prophylaxis: Beginning on day -3, patients receive oral sirolimus and taper beginning on day 61. Beginning on day -2, patients receive oral or IV tacrolimus and taper beginning on day 101. After completion of the study treatment, patients are followed every 3 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Study of a Novel Reduced Intensity Conditioning Regimen for Allogeneic Stem Cell Transplantation in Patients With Multiple Myeloma|
Experimental: Arm 1
CONDITIONING: Patients receive bortezomib IV and then undergo fractionated total-body irradiation on days -5 and -2. Patients receive thymoglobulin IV over 6 hours on days -5 to -2 and melphalan IV over 30 minutes on days -4 to -3. ALLOGENEIC STEM CELL TRANSPLANTATION: Patients undergo bone marrow or peripheral blood stem cell transplant on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Beginning on day -3, patients receive oral sirolimus and taper beginning on day 61. Beginning on day -2, patients receive oral or IV tacrolimus and taper beginning on day 101.
Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation
Procedure: allogeneic bone marrow transplantation
Drug: anti-thymocyte globulin
Given oral or IV
Radiation: total-body irradiation
Undergo total-body irradiation
Other Name: TBI
- Tolerability as assessed by CTCAE v3.0 (Phase I)
- Assessment of toxicity (Phase I)
- Proportion of successes
- Transplant-related mortality (TRM) (Phase II) [ Time Frame: 100 days ]
- Rate acute graft-vs-host disease (GVHD) (Phase I)
- Rate of grades II-IV and grades III-IV acute graft-vs-host disease (GVHD)
- Cumulative rate of chronic GVHD
- Overall response
- Overall survival
- Progression-free survival
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00995059
|Study Chair:||Martha Q. Lacy, M.D.||Mayo Clinic|
|Principal Investigator:||James L. Slack, M.D.||Mayo Clinic|