SOM230 LAR With Bortezomib and Dexamethasone for Refractory or Relapsed Multiple Myeloma
|ClinicalTrials.gov Identifier: NCT01329289|
Recruitment Status : Withdrawn (Clinical trial being transferred to Columbia University with the Investigator.)
First Posted : April 5, 2011
Last Update Posted : February 12, 2016
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma in Relapse Multiple Myeloma||Drug: SOM230 Drug: Bortezomib Drug: Dexamethasone||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of SOM230 LAR in Combination With Bortezomib and Dexamethasone in Patients With Refractory or Relapsed Multiple Myeloma|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||February 2012|
|Actual Study Completion Date :||February 2012|
|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).
- Objective tumor response [ Time Frame: 2 years ]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.
- progression-free survival [ Time Frame: 2 years ]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 ]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 ]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 ]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 ]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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01329289
|United States, Pennsylvania|
|Hillman Cancer Center|
|Pittsburgh, Pennsylvania, United States, 15232|