Safety and Efficacy of Pomalidomide, Bortezomib and Low-dose Dexamethasone ... | Not Recruiting
Safety and Efficacy of Pomalidomide... | Not Recruiting
Safety and Efficacy of Pomalidomide, Bortezomib and Low-dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
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Medical Conditions
  • Multiple Myeloma
Primary Contact Details
Unfortunately contact details are not available for this trial.
Recruitment Status
Not Recruiting
Trial source and source ID number
NCT01734928
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
The purpose of this study is to compare the efficacy of the combination of Pomalidomide, Bortezomib and Dexamethasone to the combination of Bortezomib and Dexamethasone in patients with relapsed/refractory multiple myeloma. This study will also assess how safe the combination of Pomalidomide, Bortezomib and Dexamethasone is compared to the combination of Bortezomib and Dexamethasone
Research Details
    Sorry, this information is not available
Phase
Phase 3
Study Design
Sorry, this information is not available
Study Type
Interventional
Intervention
Drug : Pomalidomide, Drug : Bortezomib, Drug : Dexamethasone

Study Arm Groups : Pomalidomide, Bortezomib and Low Dose Dexamethasone, Pomalidomide, Bortezomib and Low Dose Dexamethasone, Bortezomib and Low Dose Dexamethasone, Pomalidomide, Bortezomib and Low Dose Dexamethasone, Bortezomib and Low Dose Dexamethasone

Intervention Type
See Interventions above
Primary Outcome Measures
    Progression Free Survival; Up to 1 year
Secondary Outcome Measures
    Overall Survival; Up to 5 years; Adverse Event; Up to 1 year; Overall Response Rate; Up to 1 year; Duration of Response; Up to 1 year
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
All
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
Sorry, this information is not available
Participant Inclusion Criteria
    Inclusion Criteria:

    - Must be ≥ 18yrs at the time of signing informed consent.

    - Must have documented diagnosis of multiple myeloma and have measureable disease by serum and urine protein electrophoresis.

    - Must have had at least 1 but no greater than 3 prior anti-myeloma regimens.

    - Must have documented disease progression during or after their last anti-myeloma therapy.

    - All subjects must have received prior treatment with a lenalidomide containing regimen for at least 2 consecutive cycles.

    Exclusion Criteria:

    - Refractory to prior Bortezomib-containing therapy under the 1.3 mg/m2 dose twice weekly dosing schedule.

    - Peripheral neuropathy Grade 3, Grade 4 or Grade 2 with pain within 14 days prior to randomization.

    - Non-secretory multiple myeloma.

    - Subjects with severe renal impairment requiring dialysis.

    - Previous therapy with pomalidomide.
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
GSK Investigational Site
Sheffield
S10 2JF
Southampton General Hospital
Southampton
England
SO16 6YD
Worcester Royal Hospital
Worcester
England
WR5 1DD
South West Wales Cancer Institute
Sketty
Wales
SA2 8QA
King's College Hospital
London
SE5 9RS
Plymouth
PL6 8DH
London
NW1 2PG
Royal Bournemouth Hospital
Bournemouth
Dorset
BH7 7DW
Oxford
OX3 7DQ
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Stoke-on-Trent
ST4 6QG
Kent and Canterbury Hospital
Canterbury
CT1 3NG
Western General Hospital
Edinburgh
EH4 2XU
New Cross Hospital
Wolverhampton
WV10 OPQ
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Austria, Canada, Denmark, Finland, France, Germany, Greece, Ireland, Israel, Italy, Japan, Netherlands, Norway, Poland, Portugal, Puerto Rico, Russian Federation, Spain, Sweden, Turkey, United Kingdom, United States
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Pomalidomide, Bortezomib and Low-Dose Dexamethasone Versus Bortezomib and Low-Dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
CC-4047-MM-007
Sponsor(s)
Celgene
Key Dates

Recruitment Start Date

Jan 2013

Recruitment End Date

May 2018

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

23 Nov 2012

Date updated in source

28 Sep 2017