SOM230 LAR With Bortezomib and Dexamethasone for Refractory or Relapsed Multiple Myeloma
This study has been withdrawn prior to enrollment.
(Clinical trial being transferred to Columbia University with the Investigator.)
University of Pittsburgh
Information provided by (Responsible Party):
University of Pittsburgh
First received: March 29, 2011
Last updated: January 31, 2012
Last verified: January 2012
The purpose of this study is to determine if adding SOM230 LAR to bortezomib and dexamethasone is better than bortezomib and dexamethasone alone and if it should be investigated further.
Multiple Myeloma in Relapse
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of SOM230 LAR in Combination With Bortezomib and Dexamethasone in Patients With Refractory or Relapsed Multiple Myeloma|
Resource links provided by NLM:
Drug Information available for: Dexamethasone Dexamethasone acetate Dexamethasone sodium phosphate Sodium phosphate Sodium phosphate, dibasic Bortezomib PasireotideU.S. FDA Resources
Further study details as provided by University of Pittsburgh:
Primary Outcome Measures:
- Objective tumor response [ Time Frame: 2 years ] [ Designated as safety issue: No ]Responses (CR and PR) and incidence of SD will be tabulated by disease diagnosis. All responses will be reported. Response rate among patients with measurable disease will be summarized by exact binomial confidence intervals.
Secondary Outcome Measures:
- progression-free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]The progression free survival function will be estimated by means of the product limit (Kaplan-Meier) esitmator with 95% confidence interval. Median PFS will be estimated from the survival function.
- Toxicities associated with this investigational combination [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]Type, incidence severity (NCI-CTCAE grade), timing, relatedness of AE and laboratory abnormalities will be tabulated, with 95% confidence intervals, as appropriate.
- Effects of SOM230 LAR on PI3K/MAPK pathway [ Time Frame: 2 years ] [ Designated as safety issue: No ]Serum bone resorption markers, calcium, MIP-1alpha, TRACP-5b, serum (NTx), and serum C-terminal telopeptide (CTx) will be compared to circulating IGF-1 graphically (by scatterplots) and by Pearson or Spearman correlation coefficients, depending on the graphical assessment.
- Effect of bortezomib and SOM230 LAR on RANKL production and OCL formation [ Time Frame: 2 years ] [ Designated as safety issue: No ]Serum bone resorption markers will be measured during pretreatment and on day 1 of each cycle. Their change over time will be characterized by estimates derived from a mixed effects ANOVA model.
- IGF-1 inhibition and monitor circulating IGF-1 [ Time Frame: 2 years ] [ Designated as safety issue: No ]To analyze whether bortezomib/SOM230 LAR treatment can restore the balance between OCL and osteoblast activity, bone marrow samples will be obtained before treatment and during treatment (day 11 of cycle 2) for OCL formation assays. Mean change over time will be estimated with 95% confidence intervals, and the null hypothesis of no change tested with a paired-comparison t-test
- Overall Survival [ Time Frame: 5-10 years ] [ Designated as safety issue: No ]
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
|Experimental: SOM230 with Bortezomib and Dexamethasone||
60 mg intramuscularly (IM) on day 1 of each 28 day cycle
Other Name: PasireotideDrug: Bortezomib
1.3 mg/m2 intravenously (IV) on days 1, 4, 8, and 11 of each cycle. Bortezomib will be infused by IV push.
Other Name: VelcadeDrug: Dexamethasone
20 mg orally on day of and day after bortezomib (Days 1, 2, 4, 5, 8, 9, 11, 12).
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