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Table 2 ACCoRd study first 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 four to six cycles of ITD re-induction chemotherapy according to the protocol
2. Responded [(s)CR, VGPR or MR] or have SD according to the IMWG Uniform Response Criteria for Multiple Myeloma
3. Adequate stem cell mobilisation defined as ≥ 2 × 106 CD34+ cells/kg or ≥ 2 × 108 peripheral blood mononuclear cells (PBMCs)/kg available for transplantation (including cells stored from a previous harvest)
•Inclusion criteria 5{4}a, 6{5} and 7{6} specified in Table 1 apply to R1 inclusion criteria and hence are not included in this table
7. Adequate pulmonary function within 14 days before registration:
(a) Adequate respiratory functional reserve (delineated by KCO/DLCO (carbon monoxide diffusion in the lung) of ≥ 50%). No evidence of a history of pulmonary disease. If a significant history, then a review by a respiratory medicine physician is required.
8. Adequate cardiac function within 12 weeks before registration:
(a) Left ventricular ejection fraction (LVEF) ≥ 40%. Note: repeat confirmation of cardiac function is needed if treatment is given between this assessment and registration
 
Exclusion criteria  
1. Received any therapy for their relapsed disease other than local radiotherapy, therapeutic plasma exchange or Myeloma XII (ACCoRd) ITD treatment, prior to first 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{2}, 5{3} and 6{4} specified in Table 1 apply to R1 exclusion criteria and hence are not included in this table
5. Any contraindication to protocol treatment that would make the participant ineligible
 
  1. a5{4} notation is to be interpreted in the following way: Table 1 inclusion criteria 5 is equivalent to Table 2 inclusion criteria 4, etc.