Multiple Myeloma
Conditions
Keywords
Relapsed, Response Rate, Progression free
Brief summary
The purpose of this study is to determine the efficacy of Ixazomib when combined with Pomalidomide and Dexamethasone, in terms of overall response rate in subjects with relapsed Multiple Myeloma
Detailed description
This single arm, Phase II study will examine the efficacy and safety of the novel Proteasome/IMiD combination of Ixazomib 4mg days 1, 8, 15, Pomalidomide 4 mg days 1-21, Dexamethasone 20 mg days 1, 8, 15, and 22 of a 28 day cycle, in relapse patients. The long term aim being to develop a backbone regimen to which future novel targeted treatments may be added as part of a personalized medicine approach.
Interventions
DRUGIxazomib
4.0 mg will be given on days 1, 8 and 15 of a 28 day cycle
DRUGPomalidomide
4.0 mg will be given on days 1-21 of a 28 day cycle
DRUGDexamethasone
20 mg will be given on days 1, 8, 15 and 22 of a 28 day cycle
Sponsors
University of Arkansas
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Each patient must meet all of the following inclusion criteria to be enrolled in the study: * Male or female patients 18 years or older. * Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care. * Female patients who: Are postmenopausal for at least 1 year before the screening visit, OR Are surgically sterile, OR If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, AND Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence \[eg, calendar, ovulation, symptothermal, post-ovulation methods\] and withdrawal are not acceptable methods of contraception.) * Male patients, even if surgically sterilized (ie, status post-vasectomy), must agree to one of the following: Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods\] and withdrawal are not acceptable methods of contraception.) * Patients must have a diagnosis of relapsed and/or refractory multiple myeloma and must have received at least one line of prior therapy. Patients must be at least 14 days beyond the last multiple myeloma therapy and have recovered from acute toxicities of prior therapies measured by CTCAE (Version 4.0) * Patients must have life expectancy of at least 3 months. * Eastern Cooperative Oncology Group (ECOG) performance status and/or other performance status 0, 1, or 2. * Patients must meet the following clinical laboratory criteria: Absolute neutrophil count (ANC) \> 1,000/mm3 and platelet count\> 50,000/mm3. Platelet transfusions to help patients meet eligibility criteria are not allowed within 3 days before study enrollment. Total bilirubin \<1.5 x the upper limit of the normal range (ULN). Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 3 x ULN. Calculated creatinine clearance \> 30 mL/min (see APPENDIX C for the Cockcroft-Gault Equation).,
Exclusion criteria
\- Patients meeting any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response rate after combination of Ixazomib, Pomalidomide and Dexamethasone therapy | 28 days | Response rate will be assessed at baseline, with each scheduled study visit , including the exit visit. |
Countries
United States
Outcome results
None listed