Pomalidomide, Bortezomib, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT01212952|
Recruitment Status : Completed
First Posted : October 1, 2010
Results First Posted : April 17, 2020
Last Update Posted : April 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Refractory Multiple Myeloma||Drug: pomalidomide Drug: bortezomib Drug: dexamethasone Other: laboratory biomarker analysis Other: gene expression analysis||Phase 1 Phase 2|
I. Determine the maximum tolerated dose (MTD) of bortezomib in combination with pomalidomide and dexamethasone.
II. To evaluate the hematologic response rate (PR, VGPR, or CR) of pomalidomide, bortezomib and dexamethasone in patients with relapsed or refractory myeloma.
I. Time to progression.
II. To assess the toxicity of pomalidomide, bortezomib and dexamethasone in this patient population.
OUTLINE : This is a phase I, dose-escalation study of bortezomib followed by a phase II study. Patients receive oral pomalidomide on days 1-21; bortezomib IV on days 1, 8,15, 22; and oral dexamethasone on days 1, 8, 15, 22 . Treatment repeats every 28 days for 8 courses. Patients then receive maintenance therapy comprising oral pomalidomide 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 every 6 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||MC1082: A Phase I/II Trial of Pomalidomide (CC-4047), Bortezomib, and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma|
|Actual Study Start Date :||September 2011|
|Actual Primary Completion Date :||August 15, 2017|
|Actual Study Completion Date :||March 22, 2018|
Experimental: Arm I
Patients receive oral pomalidomide on days 1-21; bortezomib IV on days 1, 8, 15, 22; and oral dexamethasone on days 1, 8, 15, 22. Treatment repeats every 28 days for 8 courses. Patients then receive maintenance therapy comprising oral pomalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other Name: CC-4047
Other: laboratory biomarker analysis
Optional correlative studies
Other: gene expression analysis
Optional correlative studies
- Find Maximum Tolerated Dose (MTD) of Bortezomib in Combination With Pomalidomide and Dexamethasone Out to 2.5 Years, by Count of Patients With Dose Limiting Toxicities. [ Time Frame: 2.5 years ]MTD is defined as the dose level below the lowest dose that induces dose-limiting toxicity in at least one-third of patients (at least 2 of a maximum of 6 new patients).
- Number of Participants With a Hematologic Response (PR, VGPR, or CR) [ Time Frame: 2.5 years ]The number of participants who achieve PR, VGPR, or CR as defined by The International Myeloma Working Group uniform response criteria(2011). sCR: CR as defined below plus normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence. CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow. VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or > 90% reduction in serum M-protein plus urine M-protein level < 100 mg/24 h. PR: > 50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by >90% or to < 200 mg/24 h. MR: NA. SD: Not meeting criteria for CR, VGPR, PR, or progressive disease. PD: Increase of > 25% from lowest response value in any one or more of the following: Serum M-component and/or (the absolute increase must be > 0.5 g/dL), Urine M-component and/or (the absolute increase must be > 200 mg/24 h)
- Progression Free Survival [ Time Frame: 2.5 years ]The progression-free survival (PFS) time is defined as the time from registration to progression or death due to any cause. The distribution of progression-free survival will be estimated using the method of Kaplan-Meier. PD: Increase of > 25% from lowest response value in any one or more of the following: Serum M-component and/or (the absolute increase must be > 0.5 g/dL), Urine M-component and/or (the absolute increase must be > 200 mg/24 h)
- Number of Participants With Adverse Events [ Time Frame: 2.5 years ]Reported in Adverse Events section of the results
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): NCT01212952
|United States, Arizona|
|Mayo Clinic in Arizona|
|Scottsdale, Arizona, United States|
|United States, Florida|
|Mayo Clinic in Florida|
|Jacksonville, Florida, United States|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Study Chair:||Martha Lacy, M.D.||Mayo Clinic|
|Principal Investigator:||Joseph R. Mikhael, M.D.||Mayo Clinic|
|Principal Investigator:||Vivek Roy, M.D.||Mayo Clinic|