Clinical Trial: Trial of Immunomodulatory Therapy in High Risk Solitary Bone Plasmacytoma

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:

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.

Sponsor: University College, London

Current 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Overall survival [ Time Frame: 3 years from date of randomisation ]
  Time from randomisation to death of any cause will be compared between arms
• 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
• 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.
• 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.
• 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
• 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

Original Secondary Outcome: Same as current

Information By: University College, London

Dates:
Date Received: July 28, 2015
Date Started: March 10, 2017
Date Completion: December 2025
Last Updated: April 28, 2017
Last Verified: April 2017