Wild-Type Reovirus, Bortezomib, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma
|Recurrent Plasma Cell Myeloma Refractory Plasma Cell Myeloma||Drug: Bortezomib Drug: Dexamethasone Other: Laboratory Biomarker Analysis Other: Pharmacological Study Biological: Wild-type Reovirus||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||A Phase 1b Study of REOLYSIN® (Reovirus Serotype 3 - Dearing Strain) Combined With Standard Doses of Bortezomib and Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma|
- Incidence of adverse events assessed by CTCAE version 4.03 [ Time Frame: Up to 30 days post-treatment ]The safety of the bortezomib, dexamethasone, and wild-type reovirus combination will be assessed by the evaluation of the type, frequency, and severity of adverse events.
- ORR [ Time Frame: Up to 3 years ]Will determine ORR (CR + PR) in the Phase 1b part to the combination at escalating doses.
|Actual Study Start Date:||August 21, 2015|
|Estimated Study Completion Date:||August 21, 2019|
|Estimated Primary Completion Date:||August 21, 2018 (Final data collection date for primary outcome measure)|
Experimental: Treatment (dexamethasone, bortezomib, wild-type reovirus)
Patients receive dexamethasone PO, IV, or IM and bortezomib SC (preferably) or IV over 3-5 seconds on days 1, 8, and 15. Patients also receive wild-type reovirus IV over 60 minutes on days 1, 2, 8, 9, 15, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Given SC or IV
Other Names:Drug: Dexamethasone
Given PO, IV, or IM
Other Names:Other: Laboratory Biomarker Analysis
Correlative studiesOther: Pharmacological Study
Correlative studiesBiological: Wild-type Reovirus
Other Name: Reolysin
I. To determine the maximum tolerated dose (MTD) with the maximum REOLYSIN (wild-type reovirus) dose limited to 4.5 x 10^10 tissue culture infection dose (TCID)50 and the safety profile of REOLYSIN in combination with bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma (MM). (Phase 1b) II. To further explore the safety and tolerability of the combination and to determine the overall response rate (ORR) (complete response [CR] + partial response [PR]) to REOLYSIN in combination with bortezomib and dexamethasone in patients with relapsed or refractory MM. (Phase 1b Dose Expansion)
I. To determine ORR in the Phase 1b part to the combination at escalating doses.
II. To determine the progression-free survival (PFS) of patients with relapsed or refractory MM treated with REOLYSIN in combination with bortezomib and dexamethasone.
III. To evaluate the effect of REOLYSIN in combination with bortezomib and dexamethasone treatments on overall survival (OS).
IV. To conduct pharmacodynamic studies as described.
OUTLINE: This is a phase Ib, dose-escalation study of wild-type reovirus followed by a phase Ib expansion trial.
Patients receive dexamethasone orally (PO), intravenously (IV), or intramuscularly (IM) and bortezomib subcutaneously (SC) (preferably) or IV over 3-5 seconds on days 1, 8, and 15. Patients also receive wild-type reovirus IV over 60 minutes on days 1, 2, 8, 9, 15, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 1 month and then every 3 months thereafter.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02514382
|Contact: Sondra Ortiz, RN||323-865-0451||Sondra.firstname.lastname@example.org|
|Contact: Christine Duran||323-865-0371||Christine.Duran@med.usc.edu|
|United States, California|
|USC / Norris Comprehensive Cancer Center||Recruiting|
|Los Angeles, California, United States, 90033|
|Contact: Sondra R. Ortiz, RN 323-865-0451 Sondra.email@example.com|
|Principal Investigator: Kevin R. Kelly, MD|
|Principal Investigator:||Kevin Kelly, MD||University of Southern California|