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IDRIS Trial

Population Size

Not reported
Population Size statistic card

Years

2017

Years statistic card

Associated BioSamples

Availability to be confirmed

Associated BioSamples statistic card

Geographic coverage

United Kingdom

England

Geographic coverage statistic card

Lead time

Other

Lead time statistic card

Summary

Collection of samples and data across the following diseases: Plasmacytoma - category (morphologic abnormality)

Documentation

Phase III randomised study of immunomodulatory therapy in high risk solitary bone plasmacytoma. IDRIS is a randomised, open label, multicentre phase III study. The aim is to investigate whether the administration of adjuvant lenalidomide and dexamethasone following standard radiotherapy treatment for SBP prevents or prolongs the time to development of further plasmacytomas or progression to myeloma, or death (whichever comes first), in patients with high-risk disease compared with RT only. Patients are risk-stratified following registration into the trial. Risk stratification is based on BM immunophenotyping and SFLC ratio. All patients will receive standard local radiotherapy; this is not regarded as trial treatment and may be administered prior to study entry.

  • Patients with high-risk features will be randomised to receive adjuvant therapy in the form of lenalidomide and dexamethasone or no further treatment.
  • Patients without high-risk features will receive no further therapy and will be observed according to local practice. 140 patients:
  • 98 patients with high risk features to be randomised at a 1:1 ratio
  • 42 low risk patients for registration only

Dataset type

Health and disease

Dataset sub-type

Not applicable

Keywords

Provenance

Image contrast

Not stated

Biological sample availability

Availability to be confirmed

Details

Publishing frequency

Other

Version

1.0.0

Modified

08/10/2024

Distribution release date

06/01/2018

Citation Requirements

In Progress

Coverage

Start date

01/01/2017

Time lag

Variable

Geographic coverage

United Kingdom, England

Minimum age range

15

Maximum age range

150

Accessibility

Language

en

Controlled vocabulary

LOCAL

Format

In Progress

Data Access Request

Dataset pipeline status

Not available

Access rights

Please contact the publisher using Contact Point details provided

Time to dataset access

Other

Access request cost

Not specified

Access method category

Varies based on project

Data Controller

University College London

Dataset Types: Health and disease


Collection Sources:

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