A Phase 1 interventional study of fludarabine phosphate and total-body irradiation in Refractory Multiple Myeloma, Stage I Multiple Myeloma and Stage II Multiple Myeloma, sponsored by Case Comprehensive Cancer Center. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-17.
Sponsored by Case Comprehensive Cancer Center · Phase 1, Interventional, and Treatment
This phase I trial studies the side effects and best dose of lenalidomide after donor stem cell transplant and bortezomib in treating patients with high-risk multiple myeloma. Giving low doses of chemotherapy and total-body irradiation before a donor stem cell transplant helps stop the growth of cancer cells. It may also 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 a bortezomib at the time of transplant may stop this from happening. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Giving lenalidomide after donor stem cell transplant may be an effective treatment for multiple myeloma.
PRIMARY OBJECTIVES:
I. Identify the maximal tolerated dose (MTD) and safety of lenalidomide up to 10mg following non-myeloablative allogeneic stem cell transplant for multiple myeloma.
SECONDARY OBJECTIVES:
I. Assess safety and tolerability of weekly bortezomib following non-myeloablative allogeneic stem cell transplant.
II. Obtain estimates of non-relapse mortality. III. Obtain estimates of acute and chronic graft-versus-host disease (GVHD). IV. Obtain estimates of 1 year relapse and survival.
OUTLINE: This is a dose-escalation study of lenalidomide.
PREPARATIVE REGIMEN: Patients receive fludarabine phosphate on days -5 to -3 and undergo total body irradiation (TBI) on day -1.
TRANSPLANT: Patients undergo allogeneic hematopoietic stem cell transplant (SCT) on day 0.
GVHD PROPHYLAXIS: Patients receive standard GVHD prophylaxis comprising cyclosporine orally (PO) twice daily (BID) beginning on day -1 with taper beginning on day 100, mycophenolate mofetil PO BID on days 1-56, and bortezomib subcutaneously (SC) weekly from day 1 to day 91.
MAINTENANCE THERAPY: Beginning on day 100, patients receive lenalidomide PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up monthly for 1 year post-transplant.
3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.
This study's enrollment of 8 is below the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Case Comprehensive Cancer Center is the lead sponsor of 484 studies on the registry; 59 are open to participants now.
Of its 74 completed or terminated interventional studies of FDA-regulated products, 45 (61%) have results posted.
Counted across the registry records on this site, refreshed daily.
Must meet any of these criteria for high risk disease:
Exclusion Criteria:
Participants must not:
PREPARATIVE REGIMEN: Patients receive fludarabine phosphate on days -5 to -3 and undergo TBI on day -1. TRANSPLANT: Patients undergo allogeneic hematopoietic SCT on day 0. GVHD PROPHYLAXIS: Patients receive standard GVHD prophylaxis comprising cyclosporine PO BID beginning on day -1 with taper beginning on day 100, mycophenolate mofetil PO BID on days 1-56, and bortezomib SC weekly from day 1 to day 91. MAINTENANCE THERAPY: Beginning on day 100, patients receive lenalidomide PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: fludarabine phosphate · Radiation: total-body irradiation · Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation · Drug: cyclosporine · Drug: mycophenolate mofetil · Drug: bortezomib · Drug: lenalidomide · Other: laboratory biomarker analysis
Also known as: 2-F-ara-AMP, Beneflur, Fludara
Undergo TBI
Also known as: TBI
Undergo nonmyeloablative allogeneic hematopoietic SCT
Given PO
Also known as: ciclosporin, cyclosporin, cyclosporin A, CYSP, Sandimmune
Given PO
Also known as: Cellcept, MMF
Given SC
Also known as: LDP 341, MLN341, VELCADE
Given PO
Also known as: CC-5013, IMiD-1, Revlimid
Correlative studies
MTD of lenalidomide defined as one dose level below the dose in which 2 or more patients at a specified dose level experience dose limiting toxicity (DLT) according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (v. 4.0)
Time frame: Day 128 post-transplant
Safety assessed by evaluating the incidence of toxicity according to CTCAE v. 4.0
Time frame: Up to day 100
Incidence of acute GVHD according to Center for International Blood and Marrow Transplant Research (CIBMTR)
Time frame: 1 year
Incidence of chronic GVHD according to National Institutes of Health (NIH)
Time frame: 1 year
Time to deaths without relapse/recurrence
Time frame: 1 year
Progression-free survival
Time frame: From study entry to progression as defined by international response criteria or death of any cause, whichever comes first, assessed at 1 year
Overall survival
Time frame: From study entry to death from any cause, assessed at 1 year
This study is terminated, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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