PlasmacytomaPhase 3IDRISNCT02544308
Trial of Immunomodulatory Therapy in High Risk Solitary Bone Plasmacytoma
A Phase 3 study testing Lenalidomide, Dexamethasone and No further treatment in people with Plasmacytoma, run by University College, London at 13 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plasmacytoma
- What is being tested?
- Lenalidomide, Dexamethasone and No further treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 13 sitesUnited Kingdom
- Study dates
- 10 Mar 2017to Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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)
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United Kingdom13 sites
Royal United Hospital
Bath
Blackpool Victoria Hospital
Blackpool
University Hospital Wales
Cardiff
Velindre Cancer Centre
Cardiff
Beatson West of Scotland Cancer Centre
Glasgow
St James University Hospital
Leeds
University College London Hospital
London
The Christie Hospital
Manchester
Freeman Hospital
Newcastle
Mount Vernon Cancer Centre
Northwood
Royal Preston Hospital
Preston
Salisbury District Hospital
Salisbury
Southampton General Hospital
Southampton
About this study
Official title: 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.
Read the 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.
- Conditions
- Plasmacytoma
- Being tested
- Lenalidomide, Dexamethasone, No further treatment
- Keywords
- Solitary, Bone
- Medical subject headings
- Plasmacytoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenalidomideDrug
Also called Revlimid
Experimental Arm
DexamethasoneDrug
Experimental Arm
No further treatmentOther
Comparator Arm
| Study group | Role | What they receive |
|---|---|---|
| No further treatment | Active comparator | No further treatment Receives: Other: No further treatment |
| Lenalidomide + Dexamethasone | Experimental | Lenalidomide 25mg orally daily on days 1-21 Dexamethasone 20mg orally on days 1, 8, 15 \& 22 Up to 9 cycles Receives: Drug: Lenalidomide; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years from date of randomisation
Secondary outcomes (6)
Overall survival
Time from randomisation to death of any cause will be compared between arms
Measured: 3 years from date of randomisation
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
Measured: At any time during the trial (up to 6 years after last patient registered)
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.
Measured: Approximately 1 month after Lenalidomide and Dexamethasone treatment
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.
Measured: During, and one month post treatment (total approximately 10 months)
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
Measured: 5 years following treatment with lenalidomide and dexamethasone
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
Measured: 9 months from beginning of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2015 (estimated)
- Study start10 Mar 2017
- Primary completionApr 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PlasmacytomaStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Research UK, Celgene
- Responsible party
- Sponsor
- Investigators
- Roger Owen, Principal investigator, St James's University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02544308
- Sponsor's protocol ID
- UCL/13/0291
- Acronym
- IDRIS
- Status last verified
- Dec 2022
- First submitted
- 28 Jul 2015
- Last updated
- 23 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Randomised Trial of Immunomodulatory Therapy in High Risk Solitary Bone Plasmacytoma
- ClinicalTrials.gov ID
- NCT02544308
- Acronym / sponsor ID
- IDRIS / UCL/13/0291
- Conditions
- Plasmacytoma
- Keywords
- Solitary, Bone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Cancer Research UK, Celgene
- Study start
- 10 Mar 2017 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 9 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No further treatment | Active comparator | Other: No further treatmentNo further treatment |
| Lenalidomide + Dexamethasone | Experimental | Drug: Lenalidomide, Drug: DexamethasoneLenalidomide 25mg orally daily on days 1-21 Dexamethasone 20mg orally on days 1, 8, 15 \& 22 Up to 9 cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LenalidomideAlso: RevlimidExperimental Arm | Drug | Lenalidomide + Dexamethasone |
| DexamethasoneExperimental Arm | Drug | Lenalidomide + Dexamethasone |
| No further treatmentComparator Arm | Other | No further treatment |
Primary outcome
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.
6 secondary outcomes
Overall survival
Time frame: 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)
Response to treatment
Time frame: 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)
Surveillance for secondary malignancies
Time frame: 5 years following treatment with lenalidomide and dexamethasone
Treatment Compliance
Time frame: 9 months from beginning of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roger Owen principal investigator
St James's University Hospital
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lenalidomide, Dexamethasone and No further treatment in people with Plasmacytoma, run by University College, London at 13 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2022.