UARK 2015-03 A Phase II Trial of a Novel Proteasome/IMiD Combination

NCT ID: NCT02578121

Last Updated: 2017-01-23

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2017-01-31

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.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ixazomib, Pomalidomide, Dexamethasone

Protasome/IMiD combination of Ixazomib 4mg days 1, 8, and 15, Pomalidomide 4mg days 1-21 amd Dexamethasone 20 mg days 1, 8, 15 and 22 of a 28 day cycle

Group Type: EXPERIMENTAL

Ixazomib

Intervention Type: DRUG

4.0 mg will be given on days 1, 8 and 15 of a 28 day cycle

Pomalidomide

Intervention Type: DRUG

4.0 mg will be given on days 1-21 of a 28 day cycle

Dexamethasone

Intervention Type: DRUG

20 mg will be given on days 1, 8, 15 and 22 of a 28 day cycle

Interventions

Ixazomib

4.0 mg will be given on days 1, 8 and 15 of a 28 day cycle

Intervention Type: DRUG

Pomalidomide

4.0 mg will be given on days 1-21 of a 28 day cycle

Intervention Type: DRUG

Dexamethasone

20 mg will be given on days 1, 8, 15 and 22 of a 28 day cycle

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.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

• Female patients who are lactating or have a positive serum pregnancy test during the screening period.
• Failure to have fully recovered (ie, < Grade 1 toxicity) from the reversible effects of prior chemotherapy.
• Major surgery within 14 days before enrollment.
• Radiotherapy within 14 days before enrollment. If the involved field is small, 7 days will be considered a sufficient interval.
• Central nervous system involvement.
• Infection requiring systemic antibiotic therapy or other serious infection within 14 days before study enrollment.
• Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months.
• Ongoing or active systemic infection, active hepatitis B or C virus infection, or known human immunodeficiency virus (HIV) positive.
• Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
• Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.
• Known GI disease or GI procedure that could interfere with the oral absorption or tolerance of oral medications including difficulty swallowing.
• Diagnosed or treated for another malignancy within 2 years before study enrollment or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
• Patient has > Grade 3 peripheral neuropathy, or Grade 2 with pain on clinical examination during the screening period.
• Participation in other clinical trials, including those with other investigational agents not included in this trial, within 21 days of the start of this trial and throughout the duration of this trial.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Arkansas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Faith Davies, MD

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas

Locations

University of Arkansas for Medical Science

Little Rock, Arkansas, United States

Countries

United States

Other Identifiers

0203974

Identifier Type: -

Identifier Source: org_study_id