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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Trial Management Assistant
0044 113 343 5476
ctru-myelomaxii@leeds.ac.uk
Gwen Jacques, Senior Trial Coordinator
0044 113 343 1159
ctru-myelomaxii@leeds.ac.uk
Multiple Myeloma Neoplasms, Plasma Cell
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Study design: Randomised, controlled, multi-centre, open-label, phase III trial (with a single intervention registration phase).
Primary Objectives
The primary objectives of this study are to determine:
* The impact on Depth of Response (DoR: less than VGPR versus VGPR or better) when salvage ASCT conditioning is augmented by the addition of a proteasome inhibitor
* The influence of a consolidation and maintenance strategy on the Durability of Response (DuR:PFS)
Secondary objectives
The secondary objectives of this study are to determine:
* Overall survival
* Time to disease progression
* The overall response rate following ixazomib, thalidomide and dexamethasone (ITD) re-induction
* Time to next treatment
* Progression-free survival 2 (PFS2)
* Duration of response
* Minimal Residual Disease (MRD) negative rate post re-induction, post-ASCT and conversion after ITD consolidation
* Engraftment kinetics
* Toxicity and safety
* Quality of life (QoL)
Participant population (refer to protocol section 9 for a full list of eligibility criteria).
* Relapsed MM (with measurable disease by IMWG criteria) previously treated with ASCT
* First progressive disease (PD) at least 12 months since first ASCT, requiring therapy.
* ECOG Performance Status 0-2
* Aged at least 18 years
* Adequate full blood count and renal, hepatobiliary, pulmonary and cardiac function
* Written informed consent
Interventions: All participants will be registered at trial entry and will receive re-induction therapy with 4-6, 28-day cycles of ixazomib, thalidomide and dexamethasone (ITD), in order to reach maximum response. Participants who achieve at least stable disease (SD) will be randomised on a 1:1 basis to receive either conventional ASCT (ASCTCon), using melphalan, or augmented ASCT (ASCTAug), using melphalan with ixazomib. All participants achieving or maintaining a minimal response (MR) or better following trial ASCT will undergo a second randomisation to consolidation and maintenance or no further treatment. Participants randomised to consolidation and maintenance will receive treatment as follows: consolidation with 2 cycles of ITD and maintenance with ixazomib until disease progression.
Number of participants: 406 participants will be registered into the trial to allow 284 participants to be randomised at the first randomisation (R1) and 248 participants to be randomised at the second randomisation (R2).
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
"Striha A, Ashcroft AJ, Hockaday A, Cairns DA, Boardman K, Jacques G, Williams C, Snowden JA, Garg M, Cavenagh J, Yong K, Drayson MT, Owen R, Cook M, Cook G. The role of ixazomib as an augmented conditioning therapy in salvage autologous stem cell transplant (ASCT) and as a post-ASCT consolidation and maintenance strategy in patients with relapsed multiple myeloma (ACCoRd [UK-MRA Myeloma XII] trial): study protocol for a Phase III randomised controlled trial. Trials. 2018 Mar 7;19(1):169. doi: 10.1186/s13063-018-2524-8."; "29514706"
You can take part if:
You may not be able to take part if:
This is in the inclusion criteria above
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Trial Management Assistant
0044 113 343 5476
ctru-myelomaxii@leeds.ac.uk
Gwen Jacques, Senior Trial Coordinator
0044 113 343 1159
ctru-myelomaxii@leeds.ac.uk
The study is sponsored by University of Leeds and is in collaboration with Cancer Research UK; Takeda.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
