Cyclophosphamide, Bortezomib, and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma

This study has been completed.

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by:

Mayo Clinic

ClinicalTrials.gov Identifier:

NCT00609167

First received: January 31, 2008

Last updated: May 13, 2011

Last verified: May 2011

History of Changes

Results First Received: November 5, 2010

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Multiple Myeloma and Plasma Cell Neoplasm
Interventions:	Drug: bortezomib Drug: cyclophosphamide Drug: dexamethasone

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Sixty-three(63) participants were recruited between December 2006 and October 2008 at either Mayo Clinic Arizona or Princess Margaret Hospital.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
CyBorD (Bortezomib 1.3mg/m^2)	Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11 Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22 Dexamethasone 40mg PO days 1-4, 9-12, 17-20
CyBorD (Bortezomib 1.5mg/m^2)	Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22 Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22 Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22

Description

CyBorD (Bortezomib 1.3mg/m^2)

Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11

Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22

Dexamethasone 40mg PO days 1-4, 9-12, 17-20

CyBorD (Bortezomib 1.5mg/m^2)

Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22

Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22

Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22

Participant Flow: Overall Study

	CyBorD (Bortezomib 1.3mg/m^2)	CyBorD (Bortezomib 1.5mg/m^2)
STARTED	33	30
COMPLETED	25	23
NOT COMPLETED	8	7
Withdrawal by Subject	1	0
Lack of Efficacy	1	0
Adverse Event	5	1
Disease Progression	1	0
Stem Cell Transplant	0	6

Baseline Characteristics

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Reporting Groups

	Description
CyBorD (Bortezomib 1.3mg/m^2)	Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11 Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22 Dexamethasone 40mg PO days 1-4, 9-12, 17-20
CyBorD (Bortezomib 1.5mg/m^2)	Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22 Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22 Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22
Total	Total of all reporting groups

Description

CyBorD (Bortezomib 1.3mg/m^2)

Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11

Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22

Dexamethasone 40mg PO days 1-4, 9-12, 17-20

CyBorD (Bortezomib 1.5mg/m^2)

Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22

Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22

Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22

Total

Total of all reporting groups

Baseline Measures

	CyBorD (Bortezomib 1.3mg/m^2)	CyBorD (Bortezomib 1.5mg/m^2)	Total
Number of Participants [units: participants]	33	30	63
Age [units: years] Median ( Full Range )	60 ( 38 to 75 )	61 ( 36 to 70 )	61 ( 36 to 75 )
Gender [units: participants]
Female	16	14	30
Male	17	16	33
Region of Enrollment [units: participants]
United States	12	12	24
Canada	21	18	39
Parameters of Hematologic Response - Serum M-spike >=1g/dL [units: participants]
Yes	25	18	43
No	8	12	20
Parameter of Hematologic Response - Serum Immunoglobulin Free Light Chain >=10mg/dL [units: participants]
Yes	24	26	50
No	9	4	13
Parameter of Hematologic Response - Urine M-Spike >= 200mg/24 hours [units: participants]
Yes	16	11	27
No	17	19	36
Parameter of Hematologic Response - Bone Marrow Plasma Cells > 30% [units: participants]
Yes	23	22	45
No	10	8	18

Outcome Measures

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1. Primary:

Number of Participants Who Achieved a Confirmed Responses Defined as a Complete Response (CR), Near CR or Very Good Partial Response (VGPR) After the First 4 Months of Treatment [ Time Frame: After 4 months of treatment ]

Measure Type	Primary
Measure Title	Number of Participants Who Achieved a Confirmed Responses Defined as a Complete Response (CR), Near CR or Very Good Partial Response (VGPR) After the First 4 Months of Treatment
Measure Description	Response that was confirmed on 2 consecutive evaluations during the first 4 months of treatment. Complete Response(CR): Complete disappearance of M-protein from serum and urine on immunofixation, normalization of Free Light Chain (FLC) ratio and <5% plasma cells in bone marrow. near Complete Response (nCR): Patients who meet all criteria for CR except a positive immunofixation will be classified as nCR. Very Good Partial Response(VGPR): >=90% reduction in serum M-component; Urine M-Component <100mg per 24hours; <=5% plasma cells in bone marrow.
Time Frame	After 4 months of treatment
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
CyBorD (Bortezomib 1.3mg/m^2)	Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11 Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22 Dexamethasone 40mg PO days 1-4, 9-12, 17-20
CyBorD (Bortezomib 1.5mg/m^2)	Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22 Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22 Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22

Description

CyBorD (Bortezomib 1.3mg/m^2)

Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11

Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22

Dexamethasone 40mg PO days 1-4, 9-12, 17-20

CyBorD (Bortezomib 1.5mg/m^2)

Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22

Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22

Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22

Measured Values

	CyBorD (Bortezomib 1.3mg/m^2)	CyBorD (Bortezomib 1.5mg/m^2)
Number of Participants Analyzed [units: participants]	33	30
Number of Participants Who Achieved a Confirmed Responses Defined as a Complete Response (CR), Near CR or Very Good Partial Response (VGPR) After the First 4 Months of Treatment [units: participants]	20	18

No statistical analysis provided for Number of Participants Who Achieved a Confirmed Responses Defined as a Complete Response (CR), Near CR or Very Good Partial Response (VGPR) After the First 4 Months of Treatment

2. Secondary:

Progression Free Survival (PFS) [ Time Frame: up to 5 years ]

Measure Type	Secondary
Measure Title	Progression Free Survival (PFS)
Measure Description	PFS was defined as the time from registration to progression or death due to any cause. Progression was defined as any one or more of the following: An increase of 25% from lowest confirmed response in: Serum M-component (absolute increase >= 0.5g/dl) Urine M-component (absolute increase >= 200mg/24hour Difference between involved and uninvolved Free Light Chain levels (absolute increase >= 10mg/dl) Bone marrow plasma cell percentage (absolute increase of >=10%) Definite development of new bone lesion or soft tissue plasmacytomas
Time Frame	up to 5 years
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
CyBorD (Bortezomib 1.3mg/m^2)	Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11 Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22 Dexamethasone 40mg PO days 1-4, 9-12, 17-20
CyBorD (Bortezomib 1.5mg/m^2)	Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22 Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22 Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22

Description

CyBorD (Bortezomib 1.3mg/m^2)

Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11

Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22

Dexamethasone 40mg PO days 1-4, 9-12, 17-20

CyBorD (Bortezomib 1.5mg/m^2)

Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22

Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22

Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22

Measured Values

	CyBorD (Bortezomib 1.3mg/m^2)	CyBorD (Bortezomib 1.5mg/m^2)
Number of Participants Analyzed [units: participants]	33	30
Progression Free Survival (PFS) [units: months] Median ( 95% Confidence Interval )	NA ( NA to NA ) ^[1]	NA ( NA to NA ) ^[2]

[1]	The median PFS for group 1 has not been attained.
[2]	The median PFS for group 2 has not been attained

No statistical analysis provided for Progression Free Survival (PFS)

3. Secondary:

Overall Survival (OS) [ Time Frame: From date of registration until death (up to 5 years) ]

Measure Type	Secondary
Measure Title	Overall Survival (OS)
Measure Description	OS was defined as the time from registration to death of any cause.
Time Frame	From date of registration until death (up to 5 years)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
CyBorD (Bortezomib 1.3mg/m^2)	Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11 Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22 Dexamethasone 40mg PO days 1-4, 9-12, 17-20
CyBorD (Bortezomib 1.5mg/m^2)	Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22 Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22 Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22

Description

CyBorD (Bortezomib 1.3mg/m^2)

Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11

Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22

Dexamethasone 40mg PO days 1-4, 9-12, 17-20

CyBorD (Bortezomib 1.5mg/m^2)

Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22

Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22

Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22

Measured Values

	CyBorD (Bortezomib 1.3mg/m^2)	CyBorD (Bortezomib 1.5mg/m^2)
Number of Participants Analyzed [units: participants]	33	30
Overall Survival (OS) [units: months] Median ( 95% Confidence Interval )	NA ( NA to NA ) ^[1]	NA ( NA to NA ) ^[2]

[1]	Median OS for group 1 has not been attained.
[2]	Median OS for group 2 has not been attained.

No statistical analysis provided for Overall Survival (OS)

4. Secondary:

Number of Participants Who Responded to Treatment (Complete Response,CR; Near Complete Response, nCR; Very Good Partial Response, VGPR; or Partial Response, PR) After 4 Cycles [ Time Frame: 4 cycles ]

Measure Type	Secondary
Measure Title	Number of Participants Who Responded to Treatment (Complete Response,CR; Near Complete Response, nCR; Very Good Partial Response, VGPR; or Partial Response, PR) After 4 Cycles
Measure Description	Response that was confirmed on 2 consecutive evaluations after 8 months of treatment. CR, nCR and VGPR as defined in the primary outcome. Partial Response(PR): >=50% reduction in serum M-component and/or Urine M-Component >=90% reduction or <200mg per 24hours; or >=50% decrease in difference between involved and uninvolved FLC levels.
Time Frame	4 cycles
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who received 4 cycles of treatment were analyzed.

Reporting Groups

	Description
CyBorD (Bortezomib 1.3mg/m^2)	Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11 Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22 Dexamethasone 40mg PO days 1-4, 9-12, 17-20
CyBorD (Bortezomib 1.5mg/m^2)	Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22 Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22 Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22

Description

CyBorD (Bortezomib 1.3mg/m^2)

Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11

Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22

Dexamethasone 40mg PO days 1-4, 9-12, 17-20

CyBorD (Bortezomib 1.5mg/m^2)

Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22

Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22

Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22

Measured Values

	CyBorD (Bortezomib 1.3mg/m^2)	CyBorD (Bortezomib 1.5mg/m^2)
Number of Participants Analyzed [units: participants]	33	30
Number of Participants Who Responded to Treatment (Complete Response,CR; Near Complete Response, nCR; Very Good Partial Response, VGPR; or Partial Response, PR) After 4 Cycles [units: participants]	29	28

No statistical analysis provided for Number of Participants Who Responded to Treatment (Complete Response,CR; Near Complete Response, nCR; Very Good Partial Response, VGPR; or Partial Response, PR) After 4 Cycles

5. Secondary:

Duration of Response [ Time Frame: Duration of study (up to 12 cycles) ]

Measure Type	Secondary
Measure Title	Duration of Response
Measure Description	Duration of response was calculated from the documentation (date) of first response (CR, nCR, VGPR, or PR) until the date of progression or last follow-up in the subset of patients who responded.
Time Frame	Duration of study (up to 12 cycles)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who achieved a partial response(PR) or better were evaluable for this analysis.

Reporting Groups

	Description
CyBorD (Bortezomib 1.3mg/m^2)	Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11 Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22 Dexamethasone 40mg PO days 1-4, 9-12, 17-20
CyBorD (Bortezomib 1.5mg/m^2)	Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22 Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22 Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22

Description

CyBorD (Bortezomib 1.3mg/m^2)

Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11

Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22

Dexamethasone 40mg PO days 1-4, 9-12, 17-20

CyBorD (Bortezomib 1.5mg/m^2)

Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22

Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22

Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22

Measured Values

	CyBorD (Bortezomib 1.3mg/m^2)	CyBorD (Bortezomib 1.5mg/m^2)
Number of Participants Analyzed [units: participants]	29	28
Duration of Response [units: months] Median ( 95% Confidence Interval )	NA ( NA to NA ) ^[1]	NA ( NA to NA ) ^[2]

[1]	Median duration of response for group 1 was not attained.
[2]	Median duration of response for group 2 was not attained.

No statistical analysis provided for Duration of Response

6. Secondary:

Number of Participants Who Responded to Treatment (CR, nCR, VGPR or PR) After 8 Cycles [ Time Frame: After 8 cycles of treatment ]

Measure Type	Secondary
Measure Title	Number of Participants Who Responded to Treatment (CR, nCR, VGPR or PR) After 8 Cycles
Measure Description	Response that was confirmed on 2 consecutive evaluations after 8 cycles of treatment. Criteria for CR, nCR, VGPR and PR are defined in prior outcomes.
Time Frame	After 8 cycles of treatment
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who received 8 cycles of treatment were analyzed.

Reporting Groups

	Description
CyBorD (Bortezomib 1.3mg/m^2)	Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11 Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22 Dexamethasone 40mg PO days 1-4, 9-12, 17-20
CyBorD (Bortezomib 1.5mg/m^2)	Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22 Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22 Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22

Description

CyBorD (Bortezomib 1.3mg/m^2)

Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11

Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22

Dexamethasone 40mg PO days 1-4, 9-12, 17-20

CyBorD (Bortezomib 1.5mg/m^2)

Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22

Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22

Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22

Measured Values

	CyBorD (Bortezomib 1.3mg/m^2)	CyBorD (Bortezomib 1.5mg/m^2)
Number of Participants Analyzed [units: participants]	0	2
Number of Participants Who Responded to Treatment (CR, nCR, VGPR or PR) After 8 Cycles [units: participants]		1

No statistical analysis provided for Number of Participants Who Responded to Treatment (CR, nCR, VGPR or PR) After 8 Cycles

7. Secondary:

Number of Participants Who Responded to Treatment (CR, nCR, VGPR or PR) After 12 Cycles [ Time Frame: After 12 cycles of treatment ]

Measure Type	Secondary
Measure Title	Number of Participants Who Responded to Treatment (CR, nCR, VGPR or PR) After 12 Cycles
Measure Description	Response that was confirmed on 2 consecutive evaluations after 12 cycles of treatment. Criteria for CR, nCR, VGPR and PR are defined in prior outcomes.
Time Frame	After 12 cycles of treatment
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No participants received 12 cycles of treatment; therefore, all participants are non-evalualble.

Reporting Groups

	Description
CyBorD (Bortezomib 1.3mg/m^2)	Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11 Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22 Dexamethasone 40mg PO days 1-4, 9-12, 17-20
CyBorD (Bortezomib 1.5mg/m^2)	Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22 Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22 Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22

Description

CyBorD (Bortezomib 1.3mg/m^2)

Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11

Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22

Dexamethasone 40mg PO days 1-4, 9-12, 17-20

CyBorD (Bortezomib 1.5mg/m^2)

Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22

Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22

Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22

Measured Values

	CyBorD (Bortezomib 1.3mg/m^2)	CyBorD (Bortezomib 1.5mg/m^2)
Number of Participants Analyzed [units: participants]	0	0
Number of Participants Who Responded to Treatment (CR, nCR, VGPR or PR) After 12 Cycles [units: participants]

No statistical analysis provided for Number of Participants Who Responded to Treatment (CR, nCR, VGPR or PR) After 12 Cycles

8. Secondary:

Number of Participants With Severe Adverse Events [ Time Frame: Every cycle during treatment (up to 12 cycles) ]

Measure Type	Secondary
Measure Title	Number of Participants With Severe Adverse Events
Measure Description	Severe adverse events were defined as grade 3 or higher, regardless of attribution to study drugs. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.
Time Frame	Every cycle during treatment (up to 12 cycles)
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
CyBorD (Bortezomib 1.3mg/m^2)	Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11 Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22 Dexamethasone 40mg PO days 1-4, 9-12, 17-20
CyBorD (Bortezomib 1.5mg/m^2)	Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22 Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22 Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22

Description

CyBorD (Bortezomib 1.3mg/m^2)

Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11

Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22

Dexamethasone 40mg PO days 1-4, 9-12, 17-20

CyBorD (Bortezomib 1.5mg/m^2)

Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22

Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22

Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22

Measured Values

	CyBorD (Bortezomib 1.3mg/m^2)	CyBorD (Bortezomib 1.5mg/m^2)
Number of Participants Analyzed [units: participants]	33	30
Number of Participants With Severe Adverse Events [units: participants]	16	11

No statistical analysis provided for Number of Participants With Severe Adverse Events

9. Secondary:

Participants Who Successfully Completed Collection of Peripheral Blood Stem Cells for Transplant [ Time Frame: After 4 cycles of treatment ]

Measure Type	Secondary
Measure Title	Participants Who Successfully Completed Collection of Peripheral Blood Stem Cells for Transplant
Measure Description	Evaluation of the ability to successfully collect peripheral blood stem cells following four months (cycles) of combination therapy.
Time Frame	After 4 cycles of treatment
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
At the time of publication, data was available on 18 patients for group 2.

Reporting Groups

Description

CyBorD (Bortezomib 1.3mg/m^2)

Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11

Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22

Dexamethasone 40mg PO days 1-4, 9-12, 17-20

CyBorD (Bortezomib 1.5mg/m^2)

Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22

Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22

Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22

Measured Values

	CyBorD (Bortezomib 1.3mg/m^2)	CyBorD (Bortezomib 1.5mg/m^2)
Number of Participants Analyzed [units: participants]	33	18
Participants Who Successfully Completed Collection of Peripheral Blood Stem Cells for Transplant [units: participants]	33	17

No statistical analysis provided for Participants Who Successfully Completed Collection of Peripheral Blood Stem Cells for Transplant

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Dr. A. Keith Stewart
Organization: Mayo Clinic
e-mail: stewart.keith@mayo.edu

Publications of Results:

Reeder CB, Reece DE, Kukreti V, Chen C, Trudel S, Hentz J, Noble B, Pirooz NA, Spong JE, Piza JG, Zepeda VH, Mikhael JR, Leis JF, Bergsagel PL, Fonseca R, Stewart AK. Cyclophosphamide, bortezomib and dexamethasone induction for newly diagnosed multiple myeloma: high response rates in a phase II clinical trial. Leukemia. 2009 Jul;23(7):1337-41. Epub 2009 Feb 19.

Reeder CB, Reece DE, Kukreti V, Chen C, Trudel S, Laumann K, Hentz J, Pirooz NA, Piza JG, Tiedemann R, Mikhael JR, Bergsagel PL, Leis JF, Fonseca R, Stewart AK. Once- versus twice-weekly bortezomib induction therapy with CyBorD in newly diagnosed multiple myeloma. Blood. 2010 Apr 22;115(16):3416-7. No abstract available.

Responsible Party:	Alexander Keith Stewart, M.B.Ch.B, Mayo Clinic Cancer Center
ClinicalTrials.gov Identifier:	NCT00609167 History of Changes
Other Study ID Numbers:	CDR0000583225, P30CA015083, MC0686, 06-002613, NCI-2010-02147
Study First Received:	January 31, 2008
Results First Received:	November 5, 2010
Last Updated:	May 13, 2011
Health Authority:	United States: Federal Government

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