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

Primary Purpose

Plasmacytoma

Status
Active
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
Lenalidomide
Dexamethasone
No further treatment
Sponsored by
University College, London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plasmacytoma focused on measuring Solitary, Bone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Royal United Hospital
  • Blackpool Victoria Hospital
  • University Hospital Wales
  • Velindre Cancer Centre
  • Beatson West of Scotland Cancer Centre
  • St James University Hospital
  • University College London Hospital
  • The Christie Hospital
  • Freeman Hospital
  • Mount Vernon Cancer Centre
  • Royal Preston Hospital
  • Salisbury District Hospital
  • Southampton General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

No further treatment

Lenalidomide + Dexamethasone

Arm Description

No further treatment

Lenalidomide 25mg orally daily on days 1-21 Dexamethasone 20mg orally on days 1, 8, 15 & 22 Up to 9 cycles

Outcomes

Primary Outcome Measures

Progression-free survival (progression defined as development of myeloma or a new plasmacytoma outside the radiotherapy field)
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.

Secondary Outcome Measures

Overall survival
Time from randomisation to death of any cause will be compared between arms
Time to next treatment
The time from end of radiotherapy to first date of any non-protocol treatment for plasmacytoma or myeloma will be compared between arms
Response to 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.
Safety and toxicity of adjuvant lenalidomide + dexamethasone
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.
Surveillance for secondary malignancies
Second primary malignancies occurring during treatment and in the 5 years after treatment will be recorded in patients on the lenalidomide + dexamethasone arm
Treatment Compliance
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

Full Information

First Posted
July 28, 2015
Last Updated
December 22, 2022
Sponsor
University College, London
Collaborators
Cancer Research UK, Celgene
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1. Study Identification

Unique Protocol Identification Number
NCT02544308
Brief Title
Trial of Immunomodulatory Therapy in High Risk Solitary Bone Plasmacytoma
Acronym
IDRIS
Official Title
Phase III Randomised Trial of Immunomodulatory Therapy in High Risk Solitary Bone Plasmacytoma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 10, 2017 (Actual)
Primary Completion Date
April 2026 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University College, London
Collaborators
Cancer Research UK, Celgene

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plasmacytoma
Keywords
Solitary, Bone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No further treatment
Arm Type
Active Comparator
Arm Description
No further treatment
Arm Title
Lenalidomide + Dexamethasone
Arm Type
Experimental
Arm Description
Lenalidomide 25mg orally daily on days 1-21 Dexamethasone 20mg orally on days 1, 8, 15 & 22 Up to 9 cycles
Intervention Type
Drug
Intervention Name(s)
Lenalidomide
Other Intervention Name(s)
Revlimid
Intervention Description
Experimental Arm
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Experimental Arm
Intervention Type
Other
Intervention Name(s)
No further treatment
Intervention Description
Comparator Arm
Primary Outcome Measure Information:
Title
Progression-free survival (progression defined as development of myeloma or a new plasmacytoma outside the radiotherapy field)
Description
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.
Time Frame
3 years from date of randomisation
Secondary Outcome Measure Information:
Title
Overall survival
Description
Time from randomisation to death of any cause will be compared between arms
Time Frame
3 years from date of randomisation
Title
Time to next treatment
Description
The time from end of radiotherapy to first date of any non-protocol treatment for plasmacytoma or myeloma will be compared between arms
Time Frame
At any time during the trial (up to 6 years after last patient registered)
Title
Response to treatment
Description
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.
Time Frame
Approximately 1 month after Lenalidomide and Dexamethasone treatment
Title
Safety and toxicity of adjuvant lenalidomide + dexamethasone
Description
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.
Time Frame
During, and one month post treatment (total approximately 10 months)
Title
Surveillance for secondary malignancies
Description
Second primary malignancies occurring during treatment and in the 5 years after treatment will be recorded in patients on the lenalidomide + dexamethasone arm
Time Frame
5 years following treatment with lenalidomide and dexamethasone
Title
Treatment Compliance
Description
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
Time Frame
9 months from beginning of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roger Owen
Organizational Affiliation
St James's University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal United Hospital
City
Bath
Country
United Kingdom
Facility Name
Blackpool Victoria Hospital
City
Blackpool
Country
United Kingdom
Facility Name
University Hospital Wales
City
Cardiff
Country
United Kingdom
Facility Name
Velindre Cancer Centre
City
Cardiff
Country
United Kingdom
Facility Name
Beatson West of Scotland Cancer Centre
City
Glasgow
Country
United Kingdom
Facility Name
St James University Hospital
City
Leeds
Country
United Kingdom
Facility Name
University College London Hospital
City
London
Country
United Kingdom
Facility Name
The Christie Hospital
City
Manchester
Country
United Kingdom
Facility Name
Freeman Hospital
City
Newcastle
Country
United Kingdom
Facility Name
Mount Vernon Cancer Centre
City
Northwood
Country
United Kingdom
Facility Name
Royal Preston Hospital
City
Preston
Country
United Kingdom
Facility Name
Salisbury District Hospital
City
Salisbury
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Trial of Immunomodulatory Therapy in High Risk Solitary Bone Plasmacytoma

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