Trial Outcomes & Findings for A Study to Evaluate Two Different Regimens of VELCADE in Combination With Dexamethasone, Thalidomide and Cyclophosphamide (VDT vs VDTC) in Newly Diagnosed Multiple Myeloma (NCT NCT00531453)

Last Updated: 2012-01-26

Results Overview

Percent of Particpants Achieving Overall combined complete response (CR w/normalized serum κ:λ ratio + CR + near complete response (nCR)) following induction therapy. * CR criteria: negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow. * κ:λ ratio: normal free light chain (FLC) ratio * nCR criteria: positive immunofixation analysis of serum or urine as the only evidence of disease; disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

98 participants

Primary outcome timeframe

all data included in clinical database as of 10 April 2009

Results posted on

2012-01-26

Participant Flow

98 patients were enrolled between October 2007 and September 2008

All enrolled patients received at least one dose of study drug.

Participant milestones

Participant milestones
Measure	Three Drug Regimen (VDT) bortezomib, dexamethasone, and thalidomide	Four Drug Regimen (VDTC) bortezomib, dexamethasone, thalidomide, and cyclophosphamide
Overall Study STARTED	49	49
Overall Study COMPLETED	49	49
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Evaluate Two Different Regimens of VELCADE in Combination With Dexamethasone, Thalidomide and Cyclophosphamide (VDT vs VDTC) in Newly Diagnosed Multiple Myeloma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Three Drug Regimen (VDT) n=49 Participants bortezomib, dexamethasone, and thalidomide	Four Drug Regimen (VDTC) n=49 Participants bortezomib, dexamethasone, thalidomide, and cyclophosphamide	Total n=98 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	46 Participants n=5 Participants	44 Participants n=7 Participants	90 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Age Continuous	55.1 years STANDARD_DEVIATION 7.04 • n=5 Participants	55.8 years STANDARD_DEVIATION 8.27 • n=7 Participants	55.4 years STANDARD_DEVIATION 7.65 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	25 Participants n=7 Participants	51 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	24 Participants n=7 Participants	47 Participants n=5 Participants

PRIMARY outcome

Timeframe: all data included in clinical database as of 10 April 2009

Population: The response-evaluable population is defined as all subjects who have measurable disease at baseline, receive at least 1 dose of any study drug and have at least 1 post-baseline response assessment. The response-evaluable population comprises 49 subjects in the VDT treatment group and 48 subjects in the VDTC group.

Outcome measures

Outcome measures
Measure	Three Drug Regimen (VDT) n=49 Participants bortezomib, dexamethasone, and thalidomide	Four Drug Regimen (VDTC) n=48 Participants bortezomib, dexamethasone, thalidomide, and cyclophosphamide
Percent of Particpants Achieving Overall Combined Complete Response (CR) Following Induction	51 percentage of participants	44 percentage of participants

SECONDARY outcome

Timeframe: all data included in clinical database as of 10 April 2009

Population: The response-evaluable population is defined as all subjects who have measurable disease at baseline, receive at least 1 dose of any study drug and have at least 1 post-transplantation response assessment. The response-evaluable population comprises 38 subjects in the VDT treatment group and 27 subjects in the VDTC group.

Percent of Participants Achieving Overall Combined Complete Response (CR) (CR w/normalized serum κ:λ ratio + CR + Near Complete Response (nCR)) following stem cell transplantation. * CR criteria: negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow. * κ:λ ratio: normal free light chain (FLC) ratio * nCR criteria: positive immunofixation analysis of serum or urine as the only evidence of disease; disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow.

Outcome measures

Outcome measures
Measure	Three Drug Regimen (VDT) n=38 Participants bortezomib, dexamethasone, and thalidomide	Four Drug Regimen (VDTC) n=27 Participants bortezomib, dexamethasone, thalidomide, and cyclophosphamide
Percent of Participants Achieving Overall Combined Complete Response (CR) Following High-dose Chemotherapy (HDT)/Stem Cell Transplantation (SCT)	76 percentage of participants	78 percentage of participants

Adverse Events

Three Drug Regimen (VDT)

Serious events: 11 serious events

Other events: 48 other events

Deaths: 0 deaths

Four Drug Regimen (VDTC)

Serious events: 20 serious events

Other events: 47 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Three Drug Regimen (VDT) n=49 participants at risk bortezomib, dexamethasone, and thalidomide	Four Drug Regimen (VDTC) n=49 participants at risk bortezomib, dexamethasone, thalidomide, and cyclophosphamide
Infections and infestations Infections and Infestations	6.1% 3/49 • From first dose to 30 days post last dose Treatment emergent	14.3% 7/49 • From first dose to 30 days post last dose Treatment emergent
Gastrointestinal disorders Gastrointestinal Disorders	8.2% 4/49 • From first dose to 30 days post last dose Treatment emergent	8.2% 4/49 • From first dose to 30 days post last dose Treatment emergent
General disorders General Disorders and administration site Conditions	8.2% 4/49 • From first dose to 30 days post last dose Treatment emergent	8.2% 4/49 • From first dose to 30 days post last dose Treatment emergent
Musculoskeletal and connective tissue disorders Musculoskeletal and Connective Tissue Disorders	2.0% 1/49 • From first dose to 30 days post last dose Treatment emergent	14.3% 7/49 • From first dose to 30 days post last dose Treatment emergent
Respiratory, thoracic and mediastinal disorders Respiratory, Thoracic and mediastinal Disorders	6.1% 3/49 • From first dose to 30 days post last dose Treatment emergent	8.2% 4/49 • From first dose to 30 days post last dose Treatment emergent
Nervous system disorders Nervous System Disorders	6.1% 3/49 • From first dose to 30 days post last dose Treatment emergent	4.1% 2/49 • From first dose to 30 days post last dose Treatment emergent
Blood and lymphatic system disorders Blood and Lymphatic System Disorders	2.0% 1/49 • From first dose to 30 days post last dose Treatment emergent	4.1% 2/49 • From first dose to 30 days post last dose Treatment emergent
Cardiac disorders Cardiac Disorders	2.0% 1/49 • From first dose to 30 days post last dose Treatment emergent	4.1% 2/49 • From first dose to 30 days post last dose Treatment emergent
Injury, poisoning and procedural complications Injury, Poisoning and Procedural Complications	0.00% 0/49 • From first dose to 30 days post last dose Treatment emergent	4.1% 2/49 • From first dose to 30 days post last dose Treatment emergent
Metabolism and nutrition disorders Metabolism and Nutritional Disorders	2.0% 1/49 • From first dose to 30 days post last dose Treatment emergent	2.0% 1/49 • From first dose to 30 days post last dose Treatment emergent
Psychiatric disorders Psychiatric Disorders	0.00% 0/49 • From first dose to 30 days post last dose Treatment emergent	2.0% 1/49 • From first dose to 30 days post last dose Treatment emergent
Renal and urinary disorders Renal and Urinary Disorders	2.0% 1/49 • From first dose to 30 days post last dose Treatment emergent	0.00% 0/49 • From first dose to 30 days post last dose Treatment emergent
Skin and subcutaneous tissue disorders Skin and Subcutaneous Tissue Disorders	0.00% 0/49 • From first dose to 30 days post last dose Treatment emergent	2.0% 1/49 • From first dose to 30 days post last dose Treatment emergent
Vascular disorders Vascular Disorders	0.00% 0/49 • From first dose to 30 days post last dose Treatment emergent	2.0% 1/49 • From first dose to 30 days post last dose Treatment emergent

Other adverse events

Additional Information

Dr. Helgi van de Velde

Johnson & Johnson Pharmaceutical Research & Development

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Three Drug Regimen (VDT) n=49 participants at risk bortezomib, dexamethasone, and thalidomide	Four Drug Regimen (VDTC) n=49 participants at risk bortezomib, dexamethasone, thalidomide, and cyclophosphamide
Gastrointestinal disorders Gastrointestinal Disorders	61.2% 30/49 • From first dose to 30 days post last dose Treatment emergent	65.3% 32/49 • From first dose to 30 days post last dose Treatment emergent
General disorders General Disorders and Administration Site Conditions	57.1% 28/49 • From first dose to 30 days post last dose Treatment emergent	57.1% 28/49 • From first dose to 30 days post last dose Treatment emergent
Nervous system disorders Nervous System Disorders	63.3% 31/49 • From first dose to 30 days post last dose Treatment emergent	55.1% 27/49 • From first dose to 30 days post last dose Treatment emergent
Blood and lymphatic system disorders Blood and Lymphatic System Disorders	30.6% 15/49 • From first dose to 30 days post last dose Treatment emergent	44.9% 22/49 • From first dose to 30 days post last dose Treatment emergent
Musculoskeletal and connective tissue disorders Musculoskeletal and Connective Tissue Disorders	34.7% 17/49 • From first dose to 30 days post last dose Treatment emergent	26.5% 13/49 • From first dose to 30 days post last dose Treatment emergent
Infections and infestations Infections and Infestations	30.6% 15/49 • From first dose to 30 days post last dose Treatment emergent	22.4% 11/49 • From first dose to 30 days post last dose Treatment emergent
Metabolism and nutrition disorders Metabolism and Nutrition Disorders	32.7% 16/49 • From first dose to 30 days post last dose Treatment emergent	30.6% 15/49 • From first dose to 30 days post last dose Treatment emergent
Skin and subcutaneous tissue disorders Skin and Subcutaneous Tissue Disorders	36.7% 18/49 • From first dose to 30 days post last dose Treatment emergent	24.5% 12/49 • From first dose to 30 days post last dose Treatment emergent
Respiratory, thoracic and mediastinal disorders Respiratory, Thoracic and Mediastinal Disorders	18.4% 9/49 • From first dose to 30 days post last dose Treatment emergent	18.4% 9/49 • From first dose to 30 days post last dose Treatment emergent
Vascular disorders Vascular Disorders	16.3% 8/49 • From first dose to 30 days post last dose Treatment emergent	26.5% 13/49 • From first dose to 30 days post last dose Treatment emergent
Psychiatric disorders Psychiatric Disorders	18.4% 9/49 • From first dose to 30 days post last dose Treatment emergent	16.3% 8/49 • From first dose to 30 days post last dose Treatment emergent
Eye disorders Eye Disorders	12.2% 6/49 • From first dose to 30 days post last dose Treatment emergent	12.2% 6/49 • From first dose to 30 days post last dose Treatment emergent
Hepatobiliary disorders Hepatobiliary Disorders	14.3% 7/49 • From first dose to 30 days post last dose Treatment emergent	6.1% 3/49 • From first dose to 30 days post last dose Treatment emergent
Cardiac disorders Cardiac Disorders	2.0% 1/49 • From first dose to 30 days post last dose Treatment emergent	6.1% 3/49 • From first dose to 30 days post last dose Treatment emergent
Investigations Investigations	4.1% 2/49 • From first dose to 30 days post last dose Treatment emergent	10.2% 5/49 • From first dose to 30 days post last dose Treatment emergent
Ear and labyrinth disorders Ear and labyrinth Disorders	6.1% 3/49 • From first dose to 30 days post last dose Treatment emergent	6.1% 3/49 • From first dose to 30 days post last dose Treatment emergent
Injury, poisoning and procedural complications Injury, Poisoning and Procedural Complications	2.0% 1/49 • From first dose to 30 days post last dose Treatment emergent	6.1% 3/49 • From first dose to 30 days post last dose Treatment emergent
Renal and urinary disorders Renal and Urinary Disorders	4.1% 2/49 • From first dose to 30 days post last dose Treatment emergent	4.1% 2/49 • From first dose to 30 days post last dose Treatment emergent
Endocrine disorders Endocrine Disorders	2.0% 1/49 • From first dose to 30 days post last dose Treatment emergent	0.00% 0/49 • From first dose to 30 days post last dose Treatment emergent
Immune system disorders Immune System Disorders	0.00% 0/49 • From first dose to 30 days post last dose Treatment emergent	2.0% 1/49 • From first dose to 30 days post last dose Treatment emergent
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms Benign, Malignant and Unspecified	0.00% 0/49 • From first dose to 30 days post last dose Treatment emergent	2.0% 1/49 • From first dose to 30 days post last dose Treatment emergent
Reproductive system and breast disorders Reproductive System and Brest Disorders	0.00% 0/49 • From first dose to 30 days post last dose Treatment emergent	2.0% 1/49 • From first dose to 30 days post last dose Treatment emergent