Trial of Immunomodulatory Therapy in High Risk Solitary Bone Plasmacytoma (IDRIS)

December 22, 2022 updated by: University College, London

Phase III Randomised Trial of Immunomodulatory Therapy in High Risk Solitary Bone Plasmacytoma

The purpose of the trial is to establish whether adjuvant therapy with lenalidomide + dexamethasone after radiotherapy can improve progression free survival in patients with high risk solitary bone plasmacytoma compared with RT only.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Solitary bone plasmacytoma (SBP) is a localised proliferation of malignant plasma cells (PCs) in the skeleton. The annual UK incidence is 0.4/100,000 (lower than multiple myeloma (MM)) with a peak age incidence at 68 years and there are estimated to be about 260 new cases per year in the United Kingdom (UK). The majority of patients with SBP ultimately progress to myeloma and this is likely due to occult disease not detected by conventional staging methods. Standard care for these patients is involved field radiotherapy (IFRT), but despite radical doses, two-thirds develop multiple myeloma at a median of 2 years, more so if there are high risk features.

The IDRIS Trial is a phase III study where the investigators hope to demonstrate that adjuvant lenalidomide + dexamethasone following IFRT prevents the development of multiple myeloma in patients with high risk solitary bone plasmacytoma. Whilst a proportion of solitary bone plasmacytoma is cured with IFRT, it is clear that the majority will progress to multiple myeloma. The investigators are seeking to prevent this outcome by using adjuvant therapy in this study.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Bath, United Kingdom
        • Royal United Hospital
      • Blackpool, United Kingdom
        • Blackpool Victoria Hospital
      • Cardiff, United Kingdom
        • University Hospital Wales
      • Cardiff, United Kingdom
        • Velindre Cancer Centre
      • Glasgow, United Kingdom
        • Beatson West Of Scotland Cancer Centre
      • Leeds, United Kingdom
        • St James University Hospital
      • London, United Kingdom
        • University College London Hospital
      • Manchester, United Kingdom
        • The Christie Hospital
      • Newcastle, United Kingdom
        • Freeman Hospital
      • Northwood, United Kingdom
        • Mount Vernon Cancer Centre
      • Preston, United Kingdom
        • Royal Preston Hospital
      • Salisbury, United Kingdom
        • Salisbury District Hospital
      • Southampton, United Kingdom
        • Southampton General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with newly-diagnosed SBP
  • SBP treated with local radiotherapy with curative intent (see appendix 2).
  • Radiotherapy completed within 28 days of registration
  • Age ≥18 years
  • ECOG performance status 0-2
  • Written informed consent
  • Willing to comply with the requirements of the Celgene pregnancy prevention programme

Exclusion Criteria:

  • Multifocal plasmacytoma, solitary extramedullary plasmacytoma or myeloma
  • ≥10% bone marrow plasma cells
  • Clinical suspicion of failure to respond to radiotherapy
  • Receiving or intention to treat with systemic corticosteroid therapy (e.g. dexamethasone or prednisolone) unless otherwise agreed by the TMG
  • Severe hepatic impairment (bilirubin >2xULN or AST/ALT >2xULN)
  • Creatinine clearance < 30 mL/min
  • Pregnant or lactating women
  • Non-haematological malignancy within the past 3 years (exceptions apply - see section 6.2.2)
  • Patients at a high risk of venous thromboembolism due to:
  • Treatment with erythropoietic stimulating agents (e.g. erythropoietin, epoetin alpha, epoetin beta, darbepoetin alfa, methoxy polyethylene glycol-epoetin beta)
  • Other risk factors not listed above and unable to receive thromboprophylaxis
  • Patients with untreated osteoporosis
  • Patients with uncontrolled diabetes
  • Patients with a known history of glaucoma
  • Any other medical or psychiatric condition likely to interfere with study participation
  • Receiving treatment with an experimental drug or experimental medical device. Concurrent participation in non-treatment studies is allowed, if it will not interfere with participation in this study. Any experimental drug treatments must be stopped at least 4 weeks before planned start of lenalidomide and dexamethasone.
  • Evidence of current or past hepatitis B infection. Patient should test negative for both surface antigen (HBsAg) and hepatitis B core antibody (HBcAb)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: No further treatment
Other: No further treatment
Comparator Arm
Experimental: Lenalidomide + Dexamethasone
Lenalidomide 25mg orally daily on days 1-21 Dexamethasone 20mg orally on days 1, 8, 15 & 22 Up to 9 cycles
Drug: Lenalidomide
Experimental Arm
Other Names:
  • Revlimid
Drug: Dexamethasone
Experimental Arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (progression defined as development of myeloma or a new plasmacytoma outside the radiotherapy field)
Time Frame: 3 years from date of randomisation
Progression free survival rate and will be analysed using Kaplan-Meier survival analysis. PSF time will be measured from date of randomisation until progression or death.
3 years from date of randomisation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 3 years from date of randomisation
Time from randomisation to death of any cause will be compared between arms
3 years from date of randomisation
Time to next treatment
Time Frame: At any time during the trial (up to 6 years after last patient registered)
The time from end of radiotherapy to first date of any non-protocol treatment for plasmacytoma or myeloma will be compared between arms
At any time during the trial (up to 6 years after last patient registered)
Response to treatment
Time Frame: Approximately 1 month after Lenalidomide and Dexamethasone treatment
The number and proportion of patients on the lenalidomide + dexamethasone arm who achieve normalisation of the SFLCr and/or the disappearance of aberrant plasma cell phenotype following Lenalidomide + Dexamethasone treatment will be documented.
Approximately 1 month after Lenalidomide and Dexamethasone treatment
Safety and toxicity of adjuvant lenalidomide + dexamethasone
Time Frame: During, and one month post treatment (total approximately 10 months)
During treatment and follow up, the frequency and percentages of adverse events with a maximum severity of grade 3-5 (according to CTCAE v4.03) will be collected.
During, and one month post treatment (total approximately 10 months)
Surveillance for secondary malignancies
Time Frame: 5 years following treatment with lenalidomide and dexamethasone
Second primary malignancies occurring during treatment and in the 5 years after treatment will be recorded in patients on the lenalidomide + dexamethasone arm
5 years following treatment with lenalidomide and dexamethasone
Treatment Compliance
Time Frame: 9 months from beginning of treatment
Compliance with lenalidomide and dexamethasone treatment will be assessed using descriptive statistics. The number of reductions, delays and omissions of lenalidomide and dexamethasone will be presented as well as the median time on study treatment
9 months from beginning of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College, London

Collaborators

Cancer Research UK
Celgene

Investigators

  • Principal Investigator: Roger Owen, St James's University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2017

Primary Completion (Anticipated)

April 1, 2026

Study Completion (Anticipated)

December 1, 2026

Study Registration Dates

First Submitted

July 28, 2015

First Submitted That Met QC Criteria

September 4, 2015

First Posted (Estimate)

September 9, 2015

Study Record Updates

Last Update Posted (Actual)

December 23, 2022

Last Update Submitted That Met QC Criteria

December 22, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCL/13/0291

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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