Velcade (Bortezomib) Consolidation After Transplant

CR as per IMWG criteria is defined as negative immunofixation on the serum and urine and disappearance of soft tissue plasmacytomas and less than (\<) 5 percent plasma cells in bone marrow. VGPR as per IMWG criteria is defined as serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90 percent or greater reduction in serum M-protein plus urine M-protein level \<100 milligram (mg) per 24 hours.

Time frame: Month 12

Population: All response-evaluable-randomized analysis set was defined as all participants in the response-evaluable-induction set (all participants who received at least 1 dose of study medication in the induction phase and had measurable disease at baseline) who were randomized to receive consolidation treatment.

The assessment of quality of life-6D (AQoL-6D) is a multi-attribute health-related quality of life instrument (QoL). It comprises dimension scores for independent living, relationships, mental health, coping, pain, senses, and utility score for AQol-6D. Each scale ranges between 1 (best QoL) and -0.04 (worst possible QoL).

Time frame: Baseline, Month 12

Population: All treated randomized analysis set was defined as participants in the all enrolled set (participants with non-missing informed consent date,not screen failures) received at least 1 dose of any study drug and randomized to receive consolidation treatment. Here, 'N'(number of participants analyzed) participants who were evaluable for this endpoint.

Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-NTX) consists of 10 items and evaluates symptoms and concerns associated specifically with chemotherapy-induced neuropathy. 1 FACT/GOG-NTX total score has a range of 0 to 108 with a higher score indicating better quality of life.

Time frame: Baseline, Month 12

Population: All treated randomized analysis set was defined as participants in the all enrolled set (participants with non-missing informed consent date,not screen failures) received at least 1 dose of any study drug and randomized to receive consolidation treatment. Here, 'N'(number of participants analyzed) participants who were evaluable for this endpoint.

CR as per IMWG criteria is negative immunofixation on serum and urine and disappearance of soft tissue plasmacytomas and \<5 percent plasma cells in bone marrow.

Time frame: Months 3, 6, 9 and 12

Population: All response-evaluable-randomized analysis set was defined as all participants in the response-evaluable-induction set (all participants who received at least 1 dose of study medication in the induction phase and had measurable disease at baseline) who were randomized to receive consolidation treatment.

sCR as per IMWG criteria is CR plus normal free light chain (FLC) ratio and absence of clonal cells in bone marrow. CR is negative immunofixation on serum and urine and disappearance of soft tissue plasmacytomas and \<5 percent plasma cells in bone marrow.

Time frame: Months 3, 6, 9 and 12

Population: All response-evaluable-randomized analysis set was defined as all participants in the response-evaluable-induction set (all participants who received at least 1 dose of study medication in the induction phase and had measurable disease at baseline) who were randomized to receive consolidation treatment.

DFS, defined as the duration from the start of CR to the time of relapse from CR. DFS applied only to participants in CR. CR as per IMWG criteria is negative immunofixation on serum and urine and disappearance of soft tissue plasmacytomas and \<5 percent plasma cells in bone marrow. Relapse from CR: reappearance of serum or urine M-protein by immunofixation or electrophoresis; development of \>= 5 percent plasma cells in the bone marrow; appearance of any other sign of progression (ie, new plasmacytoma, lytic bone lesion, or hypercalcaemia).

Time frame: Up to 5 years

Population: Response-evaluable-randomized analysis set defined as all participants in the response-evaluable-induction set (who received at least 1 dose of study medication;had measurable disease at baseline) who were randomized to receive consolidation treatment. Here, 'N' (number of participants analyzed) signifies the participants who had complete response.

OS was defined as the time between randomization and death. Death of a participant regardless of the cause was considered as an event.

Time frame: Up to 5 years

Population: All randomized analysis set was defined as participants in the all enrolled set (all participants with a non-missing informed consent date and were not screen failures) who were randomized to receive consolidation treatment.

PFS, calculated as the time between randomization to disease progression or death (regardless of cause), whichever occurred first. Progressive disease as per IMWG criteria: increase of \>= 25 percent from lowest response level in Serum M-component and/or (the absolute increase must be \>=0.5 gram per deciliter \[g/dL\]) Urine M-component and/or (the absolute increase must be \>=200 mg/24 hour. Only in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain levels. The absolute increase must be \>10 mg/dL. Bone marrow plasma cell percentage: the absolute percent must be \>=10 percent. Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas. Development of hypercalcemia (corrected serum calcium \>11.5 mg/dL or 2.65 millimole per liter (mmol/L) that can be attributed solely to the plasma cell proliferative disorder.

Time frame: Baseline until progressive disease (up to 5 years)

Population: All response-evaluable-randomized analysis set was defined as all participants in the response-evaluable-induction set (all participants who received at least 1 dose of study medication in the induction phase and had measurable disease at baseline) who were randomized to receive consolidation treatment.