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Proteasome Inhibitor

Tandem Auto-/Nonmyeloablative Allo-HCT and Maintenance Therapy for Multiple Myeloma

Phase 2
Waitlist Available
Led By Marco Mielcarek
Research Sponsored by Fred Hutchinson Cancer Research Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 2 years after the autograft
Awards & highlights
All Individual Drugs Already Approved
Approved for 20 Other Conditions
No Placebo-Only Group

Summary

This phase II trial studies the side-effects and anti-cancer effects of giving an autologous or syngeneic stem cell transplant followed by an allogeneic donor stem cell transplant and bortezomib. Patients treated on this trial have newly diagnosed high-risk, relapsed, or refractory multiple myeloma (MM). Giving chemotherapy before an autologous stem cell transplant slows or stops the growth of cancer cells by preventing them from dividing or killing them. Stem cells that were harvested earlier from the patient's blood and frozen are then returned to the patient to replace the blood-forming cells that were destroyed by chemotherapy. Giving chemotherapy and total-body irradiation before an allogeneic donor stem cell transplant also prevents the patient's immune system from rejecting the donor's stem cells. Undergoing an autologous or syngeneic stem cell transplantation followed by an allogeneic donor stem cell transplant and bortezomib may be overall more effective in killing cancer cells.

Eligible Conditions
  • Multiple Myeloma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 100 days after the autograft or allograft
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 100 days after the autograft or allograft for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Patients Surviving Progression-free
Secondary study objectives
Number of Patients Surviving Overall
Graft-vs-Host Disease
Number of Patients With Grade II-IV Acute GVHD
+2 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Tandem Auto-/Nonmyeloablative Allo-HCT and Maintenance TherapyExperimental Treatment11 Interventions
See Detailed Description
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Syngeneic Bone Marrow Transplantation
2008
Completed Phase 2
~40
Total-Body Irradiation
1997
Completed Phase 3
~1180
Bortezomib D-mannitol
FDA approved
Mycophenolate mofetil
FDA approved
Fludarabine
FDA approved
Autologous Hematopoietic Stem Cell Transplantation
2017
Completed Phase 3
~2090
Cyclosporine
FDA approved
Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation
1997
Completed Phase 2
~440
Mechlorethamine
FDA approved
Peripheral Blood Stem Cell Transplantation
1997
Completed Phase 3
~1330

Find a Location

Who is running the clinical trial?

Fred Hutchinson Cancer Research CenterLead Sponsor
443 Previous Clinical Trials
147,924 Total Patients Enrolled
64 Trials studying Multiple Myeloma
2,932 Patients Enrolled for Multiple Myeloma
Millennium Pharmaceuticals, Inc.Industry Sponsor
404 Previous Clinical Trials
46,876 Total Patients Enrolled
82 Trials studying Multiple Myeloma
10,030 Patients Enrolled for Multiple Myeloma
Fred Hutchinson Cancer CenterLead Sponsor
570 Previous Clinical Trials
1,340,128 Total Patients Enrolled
67 Trials studying Multiple Myeloma
3,773 Patients Enrolled for Multiple Myeloma
~2 spots leftby Nov 2025
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