An Efficacy and Safety Study of Bortezomib in Participants Previously Treated for Multiple Myeloma With Limited Kidney Function

• Sponsor: Janssen-Ortho Inc., Canada (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00718640
• Collaborator: (none)
• Enrollment: 10
• Locations: 5
• Arm: 1
• Duration (Months): 27
• Patients Per Site: 2
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the effectiveness and safety of bortezomib in participants previously treated for multiple myeloma (cancer of plasma cells in bone marrow causing numerous tumors and characterized by the presence of abnormal proteins in the blood) with limited kidney function.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Drug: Dexamethasone; Drug: Bortezomib	Phase 2

Detailed Description

This is an open label (all people know the identity of the intervention), multi-center (study conducted at multiple sites), non-comparative, single arm study of bortezomib. The study consists of 3 phases: Screening phase (21 days before Day 1 of cycle 1); Treatment phase (consist of 8 cycles each cycle of 21 days or until disease progression or unacceptable toxicity); and a Follow-up phase (for participants with positive treatment response or stable disease at the final visit). Follow-up for disease progression will be done in every 3 months up to 2 years. Participants who will experience disease progression after completing at least 2 cycles of bortezomib treatment or have no change from baseline in stable disease after completing at least 4 cycles or as per Investigator's discretion will receive dexamethasone. Efficacy will be primarily evaluated by percentage of participants with renal compromised Multiple Myeloma by International Myeloma Working Group (IMWG) uniform response criteria. Participants' safety will be monitored throughout the study.

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Safety and Efficacy of Velcade in Relapsed and/or Refractory Multiple Myeloma Patients With Impaired Renal Function
• Study Start Date: Oct 1, 2007
• Actual Primary Completion Date: Dec 1, 2009
• Actual Study Completion Date: Jan 1, 2010

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Bortezomib and Dexamethasone Bortezomib 1.3 milligram (mg) per meter^2 (m^2) bolus (a large amount) intravenous (into the vein) injection will be administered once daily on Days 1, 4, 8 and 11 of each 21-day cycle with addition of Dexamethasone 20 mg per day administered orally, once daily on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-day cycle as per Investigator's discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).

Drug: Dexamethasone; Dexamethasone 20 mg per day will be administered orally on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-days cycle as per Investigator's discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).; Drug: Bortezomib; Bortezomib 1.3 milligram per meter^2 (mg/m^2), bolus intravenous injection will be administered on Days 1, 4, 8 and 11 of each 21-day cycle and up to 8 cycles.; Other Names: Velcade

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With Renal Compromised Multiple Myeloma by International Myeloma Working Group (IMWG) Uniform Response Criteria [Week 24 or Early termination visit (30-45 days after last dose)]

   The IMWG uniform response criteria define; Complete response(CR) as negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow(BM). Stringent CR as CR+normal free light chain ratio and absence of clonal cells in BM Very good partial response (PR) as serum and urine M-protein (monoclonal paraprotein) detectable by immunofixation but not on electrophoresis or 90% or >reduction in serum and urine M-protein level <100 milligram(mg) per 24 hour(hr).PR as <=50% reduction of serum and <= 90% of urine M-protein or up to <200 mg/24 hr.

Secondary Outcome Measures

1. Best Response to Treatment [Day 1 of Cycle 1, 2, 3, 4, 5, 5, 6, 7, 8 and Final/Early termination visit (30-45 days after last dose)]

   It was assessed by IMWG criteria. It defines complete response as negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow. Very good partial response as serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or > reduction in serum and urine M-protein level<100 mg per 24 hour. Partial Response as <=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by <=90% or to <200mg per 24 hr.

2. Time to Progression (TTP) of Disease [Day 1 (Start of treatment) until the date of first documented evidence of progression of disease or death]

   The TTP was defined as the time from the date of starting treatment until the date of first documented evidence of progression of disease or death.

3. Duration of Response [Day 1 (Start of treatment) until the date of first documented achievement of response]

   The duration of Response was defined as the time of first recorded achievement of a particular response level, which was defined according to IMWG uniform response criteria, as either complete response, stringent complete response, very good partial response or partial response included only responding participants, until the participants were assessed to have progressive disease.

4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score [Day 1 of Cycle 1, 3, 5, 7 and Final visit/Early termination visit (30-45 days after last dose)]

   The ECOG PS Score 0 versus 1, wherein 0 signifies fully active, able to carry all pre-disease performance without restriction and 1 signifies restriction in physically strenuous activity but ambulatory (able to walk) and able to carry out work on a light or sedentary nature.

5. Karnofsky Performance Status (KPS) Score [Day 1 of Cycle 1, 3, 5, 7 and Final visit (30-45 days after last dose) or early termination visit]

   The KPS is used to quantify participant's general well-being and activities of daily life and participants are classified based on their functional impairment. KPS score is 11-level score which ranges between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks.

6. Quality of Life Assessment by QLQ C-30 [Final Visit/Early termination visit (30-45 days after last dose)]

   The quality of life was assessed by the questionnaire QLQ C-30 designed by European Organization for the Research and Treatment of Cancer (EORTC). The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer participants. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the fatigue scale is equal to higher level of symptomatology or problems.

7. Quality of Life Assessed by Euro Quality of Life (EQ-5D) [Quality of Life (EQ-5D) Final Visit/Early termination visit (30-45 days after last dose)]

   The EQ-5D is a participant rated questionnaire to assess health-related quality of life in terms of a single utility score. It assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression where 1=better health state (no problems), 3=worst health state. Scoring formula was developed by Euro quality of life group which assigns a utility value for each domain in profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

8. Renal Function [Day 1 of Cycle 1, 2, 3, 4, 5, 5, 6, 7, 8 and Final/Early termination visit (30-45 days after last dose)]

   Renal function was analysed by creatinine clearance. Creatinine clearance was calculated by Cockroft-Gault fourmula. Creatinine clearance is equal to 140 minus age multiplied by weight and constant (1 for men and 0.85 for women) divided by creatinine in (micro mole per liter)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Participants diagnosed with symptomatic multiple myeloma based on the International Myeloma Working Group (IMWG) criteria; greater than or equal to 10 percent plasma cells in the bone marrow (or tissue biopsy) detected, monoclonal protein in the serum or urine and the, presence of end-organ injury

• Participants with measurable disease defined by at least 1 of the following 5 measurements: a) serum M-protein greater than or equal to 1 gram per deciliter (g/dl),

1. Urine M Protein greater than or equal to 200 milligram per 24 hour, c) Serum free light chain (FLC) assay: Involved FLC level greater than 10 mg per dl (mg/dl) provided serum FLC ratio is abnormal, d) Bone marrow plasma cells greater than or equal to 30 percent

• Participants who received at least 1 prior line of chemotherapy for multiple myeloma and, is refractory to or has relapsed after the last therapy

• Participants with Karnofsky performance status greater than 60 or Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

• Participants with calculated or measured creatinine clearance of less than or equal to 30 mililiter per minute (ml/min). During the screening period, 2 measures of creatinine clearance at least 7 days apart must be obtained, and both must be less than 30 ml/min

Exclusion Criteria:

• Participants who had received bortezomib in previous clinical trial and best response was progressive disease or experienced one or more serious events

• Participants who received nitorsoureas within 6 weeks, or 2 consecutive weeks of intense corticosteroids, or immunotherapy or antibody therapy within 4 weeks before enrolment

• Participants with history of allergic reaction attributable to compounds containing boron or mannitol

• Participants with peripheral neuropathy of Grade 2 or greater intensity at the time of signing informed consent form

• Pregnant or breast-feeding female participants

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		New Westminster	British Columbia	Canada
2		Vancouver	British Columbia	Canada
3		London	Ontario	Canada
4		Greenfield Park	Quebec	Canada
5		Saint John N/A		Canada

Sponsors and Collaborators

• Janssen-Ortho Inc., Canada

Investigators

• Study Director: Janssen Inc. Clinical Trial, Janssen Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Janssen-Ortho Inc., Canada
• ClinicalTrials.gov Identifier: NCT00718640
• Other Study ID Numbers: CR015082; 26866138MMY2052
• First Posted: Jul 21, 2008
• Last Update Posted: Oct 29, 2013
• Last Verified: Sep 1, 2013

• Keywords provided by Janssen-Ortho Inc., Canada: Multiple Myeloma; Velcade; Bortezomib; Dexamethasone
• Additional relevant MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Dexamethasone; Bortezomib

Study Results

Participant Flow

Arm/Group Title	Bortezomib and Dexamethasone
Arm/Group Description	Bortezomib 1.3 milligram (mg) per meter^2 (m^2) bolus (a large amount) intravenous (into the vein) injection will be administered once daily on Days 1, 4, 8 and 11 of each 21-day cycle with addition of Dexamethasone 20 mg per day administered orally, once daily on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-day cycle as per Investigator's discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).
Period Title: Overall Study
STARTED	10
COMPLETED	3
NOT COMPLETED	7

Baseline Characteristics

Arm/Group Title	Bortezomib and Dexamethasone
Arm/Group Description	Bortezomib 1.3 milligram (mg) per meter^2 (m^2) bolus (a large amount) intravenous (into the vein) injection will be administered once daily on Days 1, 4, 8 and 11 of each 21-day cycle with addition of Dexamethasone 20 mg per day administered orally, once daily on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-day cycle as per Investigator's discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).
Overall Participants	10
Age, Customized (participants) [Number]
< 65	1 10%
Between 65-69	1 10%
Between 70-74	4 40%
>=75	4 40%
Sex: Female, Male (Count of Participants)
Female	6 60%
Male	4 40%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Renal Compromised Multiple Myeloma by International Myeloma Working Group (IMWG) Uniform Response Criteria
Description	The IMWG uniform response criteria define; Complete response(CR) as negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow(BM). Stringent CR as CR+normal free light chain ratio and absence of clonal cells in BM Very good partial response (PR) as serum and urine M-protein (monoclonal paraprotein) detectable by immunofixation but not on electrophoresis or 90% or >reduction in serum and urine M-protein level <100 milligram(mg) per 24 hour(hr).PR as <=50% reduction of serum and <= 90% of urine M-protein or up to <200 mg/24 hr.
Time Frame	Week 24 or Early termination visit (30-45 days after last dose)

Outcome Measure Data

Analysis Population Description

The study was terminated. Due to insufficient number of participants, the outcome measure data was not analyzed.

Arm/Group Title	Bortezomib and Dexamethasone
Arm/Group Description	Bortezomib 1.3 milligram (mg) per meter^2 (m^2) bolus (a large amount) intravenous (into the vein) injection will be administered once daily on Days 1, 4, 8 and 11 of each 21-day cycle with addition of Dexamethasone 20 mg per day administered orally, once daily on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-day cycle as per Investigator's discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).
Measure Participants	0

2. Secondary Outcome

Title	Best Response to Treatment
Description	It was assessed by IMWG criteria. It defines complete response as negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow. Very good partial response as serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or > reduction in serum and urine M-protein level<100 mg per 24 hour. Partial Response as <=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by <=90% or to <200mg per 24 hr.
Time Frame	Day 1 of Cycle 1, 2, 3, 4, 5, 5, 6, 7, 8 and Final/Early termination visit (30-45 days after last dose)

Outcome Measure Data

Analysis Population Description

The study was terminated. Due to insufficient number of participants, the outcome measure data was not analyzed.

Arm/Group Title	Bortezomib and Dexamethasone
Arm/Group Description	Bortezomib 1.3 milligram (mg) per meter^2 (m^2) bolus (a large amount) intravenous (into the vein) injection will be administered once daily on Days 1, 4, 8 and 11 of each 21-day cycle with addition of Dexamethasone 20 mg per day administered orally, once daily on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-day cycle as per Investigator's discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).
Measure Participants	0

3. Secondary Outcome

Title	Time to Progression (TTP) of Disease
Description	The TTP was defined as the time from the date of starting treatment until the date of first documented evidence of progression of disease or death.
Time Frame	Day 1 (Start of treatment) until the date of first documented evidence of progression of disease or death

Outcome Measure Data

Analysis Population Description

The study was terminated. Due to insufficient number of participants, the outcome measure data was not analyzed.

Arm/Group Title	Bortezomib and Dexamethasone
Arm/Group Description	Bortezomib 1.3 milligram (mg) per meter^2 (m^2) bolus (a large amount) intravenous (into the vein) injection will be administered once daily on Days 1, 4, 8 and 11 of each 21-day cycle with addition of Dexamethasone 20 mg per day administered orally, once daily on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-day cycle as per Investigator's discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).
Measure Participants	0

4. Secondary Outcome

Title	Duration of Response
Description	The duration of Response was defined as the time of first recorded achievement of a particular response level, which was defined according to IMWG uniform response criteria, as either complete response, stringent complete response, very good partial response or partial response included only responding participants, until the participants were assessed to have progressive disease.
Time Frame	Day 1 (Start of treatment) until the date of first documented achievement of response

Outcome Measure Data

Analysis Population Description

The study was terminated. Due to insufficient number of participants, the outcome measure data was not analyzed.

Arm/Group Title	Bortezomib and Dexamethasone
Arm/Group Description	Bortezomib 1.3 milligram (mg) per meter^2 (m^2) bolus (a large amount) intravenous (into the vein) injection will be administered once daily on Days 1, 4, 8 and 11 of each 21-day cycle with addition of Dexamethasone 20 mg per day administered orally, once daily on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-day cycle as per Investigator's discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).
Measure Participants	0

5. Secondary Outcome

Title	Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score
Description	The ECOG PS Score 0 versus 1, wherein 0 signifies fully active, able to carry all pre-disease performance without restriction and 1 signifies restriction in physically strenuous activity but ambulatory (able to walk) and able to carry out work on a light or sedentary nature.
Time Frame	Day 1 of Cycle 1, 3, 5, 7 and Final visit/Early termination visit (30-45 days after last dose)

Outcome Measure Data

Analysis Population Description

The study was terminated. Due to insufficient number of participants, the outcome measure data was not analyzed.

Arm/Group Title	Bortezomib and Dexamethasone
Arm/Group Description	Bortezomib 1.3 milligram (mg) per meter^2 (m^2) bolus (a large amount) intravenous (into the vein) injection will be administered once daily on Days 1, 4, 8 and 11 of each 21-day cycle with addition of Dexamethasone 20 mg per day administered orally, once daily on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-day cycle as per Investigator's discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).
Measure Participants	0

6. Secondary Outcome

Title	Karnofsky Performance Status (KPS) Score
Description	The KPS is used to quantify participant's general well-being and activities of daily life and participants are classified based on their functional impairment. KPS score is 11-level score which ranges between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks.
Time Frame	Day 1 of Cycle 1, 3, 5, 7 and Final visit (30-45 days after last dose) or early termination visit

Outcome Measure Data

Analysis Population Description

The study was terminated. Due to insufficient number of participants, the outcome measure data was not analyzed.

Arm/Group Title	Bortezomib and Dexamethasone
Arm/Group Description	Bortezomib 1.3 milligram (mg) per meter^2 (m^2) bolus (a large amount) intravenous (into the vein) injection will be administered once daily on Days 1, 4, 8 and 11 of each 21-day cycle with addition of Dexamethasone 20 mg per day administered orally, once daily on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-day cycle as per Investigator's discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).
Measure Participants	0

7. Secondary Outcome

Title	Quality of Life Assessment by QLQ C-30
Description	The quality of life was assessed by the questionnaire QLQ C-30 designed by European Organization for the Research and Treatment of Cancer (EORTC). The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer participants. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the fatigue scale is equal to higher level of symptomatology or problems.
Time Frame	Final Visit/Early termination visit (30-45 days after last dose)

Outcome Measure Data

Analysis Population Description

The study was terminated. Due to insufficient number of participants, the outcome measure data was not analyzed.

Arm/Group Title	Bortezomib and Dexamethasone
Arm/Group Description	Bortezomib 1.3 milligram (mg) per meter^2 (m^2) bolus (a large amount) intravenous (into the vein) injection will be administered once daily on Days 1, 4, 8 and 11 of each 21-day cycle with addition of Dexamethasone 20 mg per day administered orally, once daily on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-day cycle as per Investigator's discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).
Measure Participants	0

8. Secondary Outcome

Title	Quality of Life Assessed by Euro Quality of Life (EQ-5D)
Description	The EQ-5D is a participant rated questionnaire to assess health-related quality of life in terms of a single utility score. It assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression where 1=better health state (no problems), 3=worst health state. Scoring formula was developed by Euro quality of life group which assigns a utility value for each domain in profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time Frame	Quality of Life (EQ-5D) Final Visit/Early termination visit (30-45 days after last dose)

Outcome Measure Data

Analysis Population Description

The study was terminated. Due to insufficient number of participants, the outcome measure data was not analyzed.

Arm/Group Title	Bortezomib and Dexamethasone
Arm/Group Description	Bortezomib 1.3 milligram (mg) per meter^2 (m^2) bolus (a large amount) intravenous (into the vein) injection will be administered once daily on Days 1, 4, 8 and 11 of each 21-day cycle with addition of Dexamethasone 20 mg per day administered orally, once daily on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-day cycle as per Investigator's discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).
Measure Participants	0

9. Secondary Outcome

Title	Renal Function
Description	Renal function was analysed by creatinine clearance. Creatinine clearance was calculated by Cockroft-Gault fourmula. Creatinine clearance is equal to 140 minus age multiplied by weight and constant (1 for men and 0.85 for women) divided by creatinine in (micro mole per liter)
Time Frame	Day 1 of Cycle 1, 2, 3, 4, 5, 5, 6, 7, 8 and Final/Early termination visit (30-45 days after last dose)

Outcome Measure Data

Analysis Population Description

The study was terminated. Due to insufficient number of participants, the outcome measure data was not analyzed.

Arm/Group Title	Bortezomib and Dexamethasone
Arm/Group Description	Bortezomib 1.3 milligram (mg) per meter^2 (m^2) bolus (a large amount) intravenous (into the vein) injection will be administered once daily on Days 1, 4, 8 and 11 of each 21-day cycle with addition of Dexamethasone 20 mg per day administered orally, once daily on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-day cycle as per Investigator's discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).
Measure Participants	0

Adverse Events

Time Frame	Day 1 up to 30 days after last dose of study medication
Arm/Group Title	Bortezomib and Dexamethasone
Arm/Group Description	Bortezomib 1.3 milligram (mg) per meter^2 (m^2) bolus (a large amount) intravenous (into the vein) injection will be administered once daily on Days 1, 4, 8 and 11 of each 21-day cycle with addition of Dexamethasone 20 mg per day administered orally, once daily on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-day cycle as per Investigator's discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).
All Cause Mortality
	Bortezomib and Dexamethasone
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Bortezomib and Dexamethasone
	Affected / at Risk (%)	# Events
Total	4/10 (40%)
Gastrointestinal disorders
Diarrhoea	1/10 (10%)
Gastrointestinal haemorrhage	1/10 (10%)
Infections and infestations
Pneumonia	1/10 (10%)
Metabolism and nutrition disorders
Dehydration	1/10 (10%)
Musculoskeletal and connective tissue disorders
Muscle weakness	1/10 (10%)
Nervous system disorders
Depressed level of consciousness	1/10 (10%)
Aphasia	1/10 (10%)
Speech disorder	1/10 (10%)
Psychiatric disorders
Confusion state	1/10 (10%)
Renal and urinary disorders
Renal impairment	1/10 (10%)
Vascular disorders
Hypertension	1/10 (10%)
Other (Not Including Serious) Adverse Events
	Bortezomib and Dexamethasone
	Affected / at Risk (%)	# Events
Total	9/10 (90%)
Blood and lymphatic system disorders
Thrombocytopenia	3/10 (30%)
Lymphopenia	1/10 (10%)
Leukopenia	1/10 (10%)
Anaemia	2/10 (20%)
Gastrointestinal disorders
Vomiting	1/10 (10%)
Diarrhoea	1/10 (10%)
Constipation	1/10 (10%)
Abdominal pain	1/10 (10%)
General disorders
Fatigue	2/10 (20%)
Asthenia	1/10 (10%)
Infections and infestations
Herpes zoster	1/10 (10%)
Bacteraemia	1/10 (10%)
Injury, poisoning and procedural complications
Contusion	1/10 (10%)
Investigations
International normalised ratio increased	1/10 (10%)
Blood creatinine increased	4/10 (40%)
Blood albumin decreased	1/10 (10%)
Metabolism and nutrition disorders
Hypokalaemia	2/10 (20%)
Hypocalcaemia	1/10 (10%)
Anorexia	1/10 (10%)
Musculoskeletal and connective tissue disorders
Muscular weakness	2/10 (20%)
Nervous system disorders
Peripheral sensory neuropathy	1/10 (10%)
Neuropathy peripheral	1/10 (10%)
Neuralgia	2/10 (20%)
Psychiatric disorders
Mood altered	1/10 (10%)
Confusional state	1/10 (10%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea	2/10 (20%)
Cough	1/10 (10%)
Vascular disorders
Hypotension	1/10 (10%)
Orthostatic hypotension	1/10 (10%)
Hypertension	1/10 (10%)

Limitations/Caveats

Participants' recruitment was limited due to pre-defined criteria of renal disease and requirement of repeated evaluation of creatinine clearance. Due to insufficient number of participants the outcome measure data was not analyzed.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.