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SOM230 LAR With Bortezomib and Dexamethasone for Refractory or Relapsed Multiple Myeloma
Plain-language guide to NCT01329289: phase 2 interventional trial of Pasireotide. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01329289
- Phase
- phase 2
- Status
- withdrawn
- Start
- 2011-12
- Completion (planned or actual)
- 2012-02
- Participants
- n/a (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Multiple Myeloma in Relapse; Multiple Myeloma
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 2 trial tested Pasireotide.
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.
It had 1 arm (groups): SOM230 with Bortezomib and Dexamethasone (experimental).
The registry classes the interventions as drug.
Who Took Part
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Age ≥ 18 years. Life expectancy of greater than 12 weeks. Patients must have adequate organ and marrow function as defined below, obtained within 4 weeks prior to registration:. Absolute neutrophil count \> 1000 x 10-9/L. Platelets ≥ 50,000 x 10-9/L.
The full record lists 25 inclusion and 27 exclusion criteria; among the exclusions: patients with any of the following cardiac abnormalities:; QTcF at screening \> 450 msec; concomitant disease(s) that could prolong qt such as autonomic neuropathy (caused by diabetes, or parkinson's disease), hiv, cirrhosis, uncontrolled hypothyroidism or cardiac failure.
How the Study Was Run
It was run as a single-group and open-label study.
Everyone knew when Pasireotide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2011-12 with completion listed for 2012-02.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Objective tumor response (time frame: 2 years).
It also tracked 6 secondary outcomes, for example progression-free survival, Effects of SOM230 LAR on PI3K/MAPK pathway, Effect of bortezomib and SOM230 LAR on RANKL production and OCL formation, IGF-1 inhibition and monitor circulating IGF-1 and Overall Survival.
What This Means in Plain Language
Put simply, this is a phase 2 trial of Pasireotide in people.
It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Pasireotide compound page, all human trials.
Our Notes on the Compound
Pasireotide: An FDA-approved multi-receptor somatostatin analog for Cushing's disease and acromegaly; high blood sugar is a common side effect.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.