Re-invigorating rather than re-inventing the wheel: augmenting the impact of salvage autologous stem cell transplantation for multiple myeloma in the era of novel agents

Cook, Gordon

doi:10.1038/bmt.2015.175

Cited by 2 publications

(1 citation statement)

References 11 publications

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“…There is some evidence that molecular risk stratification at relapse after a prior transplant may delineate subgroups where a second transplant offers no advantage in terms of DuR. This clearly requires a more in-depth examination [ 9 ], as, currently, there is no evidence basis to make a clinical judgment about the use of consolidation or maintenance in the salvage ASCT setting.…”

Section: Introductionmentioning

confidence: 99%

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

Striha

Ashcroft

Hockaday

et al. 2018

Trials

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BackgroundMultiple myeloma (MM) is a plasma cell tumour with an approximate annual incidence of 4500 in the UK. Therapeutic options for patients with MM have changed in the last decade with the arrival of proteasome inhibitors and immunomodulatory drugs. Despite these options, almost all patients will relapse post first-line autologous stem cell transplantation (ASCT). First relapse management (second-line treatment) has evolved in recent years with an expanding portfolio of novel agents, driving response rates influencing the durability of response. A second ASCT, as part of relapsed disease management (salvage ASCT), has been shown to prolong the progression-free survival and overall survival following a proteasome inhibitor-containing re-induction regimen, in the Cancer Research UK-funded National Cancer Research Institute Myeloma X (Intensive) study. It is now recommended that salvage ASCT be considered for suitable patients by the International Myeloma Working Group and the National Institute for Health and Care Excellence NG35 guidance.Methods/designACCoRd (Myeloma XII) is a UK-nationwide, individually randomised, multi-centre, multiple randomisation, open-label phase III trial with an initial single intervention registration phase aimed at relapsing MM patients who have received ASCT in first-line treatment. We will register 406 participants into the trial to allow 284 and 248 participants to be randomised at the first and second randomisations, respectively.All participants will receive re-induction therapy until maximal response (four to six cycles of ixazomib, thalidomide and dexamethasone). Participants who achieve at least stable disease will be randomised (1:1) to receive either ASCTCon, using high-dose melphalan, or ASCTAug, using high-dose melphalan with ixazomib. All participants achieving or maintaining a minimal response or better, following salvage ASCT, will undergo a second randomisation (1:1) to consolidation and maintenance or observation. Participants randomised to consolidation and maintenance will receive consolidation with two cycles of ixazomib, thalidomide and dexamethasone, and maintenance with ixazomib until disease progression.DiscussionThe question of how best to maximise the durability of response to salvage ASCT warrants clinical investigation. Given the expanding scope of oral therapeutic agents, patient engagement with long-term maintenance strategies is a real opportunity. This study will provide evidence to better define post-relapse treatment in MM.Trial registrationISRCTN, ISRCTN10038996. Registered on 15 December 2016.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-2524-8) contains supplementary material, which is available to authorized users.

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Section: Introductionmentioning

confidence: 99%

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

Striha

Ashcroft

Hockaday

et al. 2018

Trials

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When to recommend a second autograft in patients with relapsed myeloma?

Ziogas

Terpos

Dimopoulos

2016

Leukemia & Lymphoma

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In the current evolving landscape of myeloma therapies, no recommended salvage strategy exists for patients with relapsed multiple myeloma (MM) after initial successful autologous stem cell transplantation (ASCT) and therapeutic options extend from conventional chemotherapy and novel agents to second autologous and allogeneic transplants. In this article, we summarize the documented evidence about the utilization of second ASCT in patients with relapsed MM after a primary auto-graft and discuss the correct timing for such a salvage approach, the individual characteristics of patients who will benefit more, as well as the therapeutic role of second ASCT in the modern era of forthcoming anti-myeloma treatments.

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Re-invigorating rather than re-inventing the wheel: augmenting the impact of salvage autologous stem cell transplantation for multiple myeloma in the era of novel agents

Cited by 2 publications

References 11 publications

When to recommend a second autograft in patients with relapsed myeloma?

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