Combination Study for High Risk Multiple Myeloma Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03104270|
Recruitment Status : Recruiting
First Posted : April 7, 2017
Last Update Posted : March 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: Elotuzumab Drug: Pomalidomide Drug: Carfilzomib Drug: Dexamethasone||Phase 2|
This is a Phase 2, multicenter, open label, nonrandomized study with six patients safety lead-in cohort to evaluate efficacy and safety of elotuzumab in combination with pomalidomide, carfilzomib and dexamethasone among high risk relapsed and refractory multiple myeloma patients.
This study will enroll previously treated patients that currently show evidence of progressive disease and have been diagnosed with high risk multiple myeloma. Thirty-nine patients will be enrolled in the study.
First, six patients will be enrolled and used as a lead-in cohort for the safety evaluation and MTD re-determination (if necessary). The results of the safety lead-in cohort will be evaluated after the 6th patient has completed one full cycle of treatment. Recruitment of patients will be withheld during safety data analysis. Enrollment of the remaining 33 patients will be contingent upon safety committee's decision.
The study consists of: 1) a screening period; 2) up to eight 28-day treatment cycles; 3) a final assessment to occur 28 days after the end of the last treatment cycle; and 4) a follow-up period.
All drugs will be administered on a 28-day cycle schedule throughout the study. Subjects eligible for this study will receive treatment with study drug for a maximum of eight 28-day treatment cycles. Subjects are to be treated for 8 cycles of therapy without demonstrating PD.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Trial of the Efficacy and Safety of Elotuzumab in Combination With Pomalidomide, Carfilzomib and Dexamethasone Among High Risk Relapsed/ Refractory Multiple Myeloma Patients|
|Actual Study Start Date :||March 13, 2017|
|Estimated Primary Completion Date :||February 2020|
|Estimated Study Completion Date :||May 2020|
Experimental: Elo Pom Car and Dex
Drug dosing and administration:
All drugs are administered on a 28-day cycle.
Elotuzumab: 10 mg/kg IV on Days 1,8,15 and 22 Cycles 1 and 2 and Days 1 and 15 Cycles 3 and beyond.
Pomalidomide: 3 mg PO on days 1-21
Carfilzomib: 20 mg/m2 IV on days 1 and 2 of cycle 1. 27 mg/m2 IV on days 8, 9, 15 and 16 of cycle 1, and days 1,2,8,9,15 and 16 of the remaining seven cycles.
Dexamethasone: Pre-treatment with 28 mg PO 3-24 hours prior to the start of ELO on days 1,8,15 and 22 of Cycle 1 and 2 and 8mg IV 45-90 minutes prior to the start of ELO Pre-treatment with 28 mg PO on days 1 and 15 and 40 mg PO on days 8 and 22 of Cycle 3 and beyond. On Days 2, 9 and 16 of all cycles 4 mg IV at least 30 min and no more than 4 hours prior to the start of CFZ.
Elotuzumab IV at 10mg/kg once a week.
Other Name: BMS-901608
Pomalidomide capsules will be administered per Orem (PO) at 3 mg daily
Other Name: CC-4047, Pomalyst
Carfilzomib will be given as an IV infusion over 30 min at 20 mg/m2 on days 1 and 2 of cycle 1 and at 27 mg/m2
Other Name: Kyprolis
28 mg of dexamethasone administered PO in the morning the day before of ELO infusion.
Other Name: Steroid
- Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) [ Time Frame: 34 Months ]Occurrence of adverse events throughout the study, graded via Common Terminology Criteria for Adverse Events (CTCAE) v 4.03 criteria (If necessary re-define MTD via the number of dose-limiting toxicities (DLTs) per dose level, of elotuzumab in combination with pomalidomide, carfilzomib and dexamethasone for high risk RRMM patients (based on six patients lead-in cohort if necessary).
- Efficacy [ Time Frame: 34 Months ]Efficacy of treatment will be assessed by the Overall response rate (ORR) [ORR=complete response (CR†) + very good partial response (VGPR) + partial response (PR)] Clinical benefit rate (CBR) [CBR=CR† + VGPR + PR + minor response (MR)].
- PFS [ Time Frame: 34 Months ]Progression-free survival (PFS): time from initiation of therapy to progressive disease or death from any cause, whichever comes first
- DOR [ Time Frame: 34 Months ]Duration of response (DOR): time from the first response (> PR) to progressive disease
- OS [ Time Frame: 34 Months ]Overall survival (OS): time from initiation of therapy to death from any cause or last follow-up visit.
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): NCT03104270
|Contact: James R Berenson, MDfirstname.lastname@example.org|
|Contact: Noemi Silagan||(310)email@example.com|
|United States, California|
|California Cancer Associates for Research & Excellence (cCARE)||Recruiting|
|Encinitas, California, United States, 92024|
|Contact: Daniela Slavin, PhD 760-452-3909 firstname.lastname@example.org|
|Principal Investigator: Alberto Bessudo, MD|
|Pacific Cancer Care||Recruiting|
|Monterey, California, United States, 93940|
|Contact: Anab Mohamed 831-375-4105 email@example.com|
|Principal Investigator: Laura Stampleman, MD|
|James Berenson, MD, Inc||Recruiting|
|West Hollywood, California, United States, 90069|
|Contact: Regina Swift, RN 310-623-1227 firstname.lastname@example.org|
|Principal Investigator: James R Berenson, MD|
|United States, Florida|
|Millennium Oncology Research Clinic||Recruiting|
|Pembroke Pines, Florida, United States, 33024|
|Contact: Maria Contreras, MD 954-266-7885 email@example.com|
|Principal Investigator: Isaac Levy, MD|
|Principal Investigator:||James R Berenson, MD||Oncotherapeutics|