Table 3 ACCoRd study second randomisation inclusion and exclusion criteria

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 K_CO/D_LCO (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