Lenalidomide/Bortezomib/Dexamethasone for Multiple Myeloma (MM)

Participants are considered to have achieved an objective response if they meet the International Myeloma Working Group uniform response criteria for any of the following: * Stringent CR: Same as CR plus normal free light chain ratio and absence of clonal cells plasma cells in bone marrow (BM) * CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in BM * VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \<100 mg per 24 hours * PR: ≥50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥90% or to \<200 mg per 24 hours. If the serum and urinary M-protein are not measurable, additional criteria are used to assess PR that will not fit in the space provided here. If present at baseline, a ≥50% reduction in the size of plasmacytomas is also required

Time frame: 2 years

The pharmacokinetic profile of intravenous and subcutaneous bortezomib administration in combination with lenalidomide and dexamethasone.

Time frame: Day 1 (5 min, 30min, 5 hours post dose), Days 8, 15, Day 22 (pre dose and 5 min, 30 min, 5 hrs post dose), cycle 2 day 1 pre dose

Population: A total of only 10 participants per arm were evaluated for drug plasma concentrations following Bortezomib administration.The number of participants vary by time-point due to missing measurements for the concentrations.

The median overall survival as measured from the start of treatment until the time of death due to any cause.

Time frame: From the start of treatment until death or until 5 years after the time of disease progression

Population: Median overall survival was not met before the end of follow-up/ data cutoff point because more than half of the participants were still alive.

The median amount of time as measured from the start of treatment until either death or progression. Progressive disease requires 1 or more of the following: * \>=25% increase from lowest response level in serum M-protein (\>=0.5 g/dL absolute increase) and/or urine M-component (\>=200 mg/24hr absolute increase) * \>=25% increase in the difference between involved and uninvolved FLC levels (absolute increase \>10 mg/dL). Only for use in patients without measurable serum and M-protein levels. * \>=25% increase in bone marrow plasma cell percentage (absolute percentage \>=10%) * New or increase in existing bone lesions or soft tissue plasmacytomas * Hypercalcemia (serum calcium \>11.5 mg/dL) due solely to the plasma cell proliferative disorder.

Time frame: From the start of treatment until death or progression or until 3 years after the last participant is enrolled

Median amount of time from the start of treatment until first documented response as defined by the International Myeloma Working Group uniform response criteria Stringent CR: Same as CR plus normal free light chain ratio and absence of clonal cells plasma cells in bone marrow (BM) CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in BM VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \<100 mg per 24 hours PR: ≥50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥90% or to \<200 mg per 24 hours. If the serum and urinary M-protein are not measurable, additional criteria are used to assess PR that will not fit in the space provided here. If present at baseline, a ≥50% reduction in the size of plasmacytomas is also required

Time frame: From the start of treatment until the time of first documented response, median duration of 1.1 months

Population: Participants that achieved a response

A summary of the number of participants with grade 3 or higher treatment related adverse events for adverse events that had an overall incidence of greater than 15% (any grade) as assessed by Common Terminology Criteria for Adverse Events (CTCAE 4).

Time frame: 2 years

To evaluate pharmacogenomic markers among patients with treatment related polyneuropathy.

Time frame: 2 years

Population: No pharmacogenomic markers were evaluated for relation to neuropathy

Response rate was assessed using the International Myeloma Working Group uniform response criteria. Stringent complete response, Complete Response, Very Good Partial Response, and Partial Response are defined in outcome measure 1. * MR included participants in whom some, but not all, criteria for PR were fulfilled, providing the remaining criteria satisfied the requirements for MR. Required all of the following: * ≥25% to ≤ 49% reduction in the level of serum monoclonal protein for at least two determinations six weeks apart. * If present, a 50 to 89% reduction in 24-hour light chain excretion, which still exceeds 200 mg/24 h, for at least two determinations six weeks apart. * 25-49% reduction in the size of plasmacytomas (by clinical or radiographic examination) for at least six weeks. * No increase in size or number of lytic bone lesions (development of compression fracture does not exclude response). * Stable Disease: Not meeting the criteria for minimal response or

Time frame: 2 years