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Table 3 ACCoRd study second randomisation inclusion and exclusion criteria

From: 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

Inclusion criteria  
1. Registered into the ACCoRd trial and received ASCT as per randomised treatment allocation according to the protocol
• Inclusion criteria 2{2} (excluding SD response), 4{3}a, 5{4}, 6{5} and 8{7} specified in Table 2 apply to R2 eligibility criteria and hence are not included in this table
6. Adequate pulmonary function within 14 days before randomisation:
(a) No clinical evidence of deterioration in pulmonary function since first randomisation. If there is evidence of clinical deterioration, then adequate respiratory functional reserve (delineated by KCO/DLCO (carbon monoxide diffusion in the lung) of ≥ 50%)
8. If female and of childbearing potential, must have a negative pregnancy test within 14 days prior to randomisation, performed by a healthcare professional in accordance with the Celgene Thalidomide Pregnancy Prevention Programme
 
Exclusion criteria  
1. Received any therapy for their relapsed disease other than local radiotherapy, therapeutic plasma exchange or Myeloma XII (ACCoRd) protocol treatment prior to second randomisation. (Radiotherapy sufficient to alleviate or control pain of local invasion is permitted, but not within 14 days prior to randomisation. Participants who have received hemi-body radiation since relapse will not be eligible.)
• Exclusion criteria 2–5{2–5} specified in Table 2 apply to R2 eligibility and hence are not included in this table
 
  1. a4{3} notation is to be interpreted in the following way: Table 2 inclusion criteria 4 is equivalent to Table 3 inclusion criteria 3. In this case, the notation does not transfer back to Table 1