Trial Outcomes & Findings for Phase II Study of Velcade, Decadron, and Doxil Followed by Cyclophosphamide in Multiple Myeloma (NCT NCT00148317)

NCT ID: NCT00148317

Last Updated: 2017-07-18

Results Overview

Myeloma response criteria developed by Bladé et al. was used to categorize response.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 38 participants
• Primary outcome timeframe: Best response at any point during each respective study phase was collected - once after consolidation/prior to mobilization (approximately 6 cycles after start of treatment), and once after mobilization
• Results posted on: 2017-07-18

Participant Flow

Participant milestones

Measure	Overall Study
Consolidation (VEL + DEX) STARTED	38
Consolidation (VEL + DEX) DOXIL Added at Cycle 3	16
Consolidation (VEL + DEX) DOXIL Added at Cycle 5	12
Consolidation (VEL + DEX) no DOXIL Added	10
Consolidation (VEL + DEX) COMPLETED	38
Consolidation (VEL + DEX) NOT COMPLETED	0
Mobilization (VEL+CYTOXAN+FILGRASTIM) STARTED	38
Mobilization (VEL+CYTOXAN+FILGRASTIM) COMPLETED	27
Mobilization (VEL+CYTOXAN+FILGRASTIM) NOT COMPLETED	11

Reasons for withdrawal

Measure	Overall Study
Mobilization (VEL+CYTOXAN+FILGRASTIM) Adverse Event	8
Mobilization (VEL+CYTOXAN+FILGRASTIM) Lack of Efficacy	2
Mobilization (VEL+CYTOXAN+FILGRASTIM) unable to tolerate	1

Baseline Characteristics

Phase II Study of Velcade, Decadron, and Doxil Followed by Cyclophosphamide in Multiple Myeloma

Baseline characteristics by cohort

Measure	Treatment Arm (All Patients) n=38 Participants Bortezomib, Dexamethasone, Pegylated Liposomal Doxorubicin, Cyclophosphamide: Bortezomib 1.3 mg/m2 days 1, 4, 8, 11 (initial cycles) Dexamethasone 40 mg Days 1-4, 8-11, 15-18 (initial cycles) Doxil 30 mg/m2 Day 4 of subsequent cycles
Age, Continuous	61 years n=5 Participants
Age, Customized Age <70 years	34 Participants n=5 Participants
Age, Customized Age > or = 70	4 Participants n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	34 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	26 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants
Beta-2 Microglubilin	2.05 mg/L n=5 Participants
Serum Albumin	3.5 g/dL n=5 Participants
Durie Salmon Staging System 1a	1 participants n=5 Participants
Durie Salmon Staging System 2a	19 participants n=5 Participants
Durie Salmon Staging System 3a	17 participants n=5 Participants
Durie Salmon Staging System 3b	1 participants n=5 Participants
International Staging System I	18 participants n=5 Participants
International Staging System II	17 participants n=5 Participants
International Staging System III	3 participants n=5 Participants
Abnormalities by FISH trisomy 11	10 participants n=5 Participants
Abnormalities by FISH hyperdiploidy	7 participants n=5 Participants
Abnormalities by FISH t (4;14)	4 participants n=5 Participants
Abnormalities by FISH p53	4 participants n=5 Participants
Abnormalities by FISH del (17p)	1 participants n=5 Participants
Abnormalities by FISH t (11;14)	5 participants n=5 Participants
Abnormalities by FISH t (14;16)	2 participants n=5 Participants
Abnormalities by FISH none	16 participants n=5 Participants
Prior induction therapy lenalidomide + dexamethasone ± BIAXIN	21 participants n=5 Participants
Prior induction therapy Thalidomide + lenalidomide + dexamethasone± BIAXIN	8 participants n=5 Participants
Prior induction therapy Thalidomide + dexamethasone	3 participants n=5 Participants
Prior induction therapy thalidomide only	2 participants n=5 Participants
Prior induction therapy pulsed dexamethasone only	2 participants n=5 Participants
Prior induction therapy melphalan + cyclophosphamide	1 participants n=5 Participants
Prior induction therapy dexamethasone, then single-agent lenalidomide	1 participants n=5 Participants
Best response prior to induction therapy Complete Response	1 participants n=5 Participants
Best response prior to induction therapy partial Response	27 participants n=5 Participants
Best response prior to induction therapy Stable Disease	10 participants n=5 Participants

PRIMARY outcome

Timeframe: Best response at any point during each respective study phase was collected - once after consolidation/prior to mobilization (approximately 6 cycles after start of treatment), and once after mobilization

Population: All 38 patients were treated with DoVeD consolidation therapy (Vel + DEX with or without DOXIL). Of the 38 patients enrolled, 27 proceeded to mobilization (11 did not undergo mobilization). Responses were assessed prior to mobilization (post DoVED), and again after mobilization, to see if mobilization improved patient response.

Myeloma response criteria developed by Bladé et al. was used to categorize response.

Outcome measures

Measure	Treatment Arm - Post Mobilization n=27 Participants This is the response rate assessed for patients after their bortezomib-based mobilization.	Treatment Arm - Responses Prior to Mobilization n=38 Participants This is the overall best response rate (ORR, ≥PR, as measured by ≥50% reduction in M-protein) to DoVeD therapy from post-primary induction (pre-DoVeD).
Efficacy of Drug Combination as Therapy for Myeloma (Overall Response Rate) Stringent Complete Response (sCR)	4 participants	0 participants
Efficacy of Drug Combination as Therapy for Myeloma (Overall Response Rate) Complete Response (CR)	3 participants	1 participants
Efficacy of Drug Combination as Therapy for Myeloma (Overall Response Rate) Very Good Partial response (VGPR)	6 participants	1 participants
Efficacy of Drug Combination as Therapy for Myeloma (Overall Response Rate) Partial Response (PR)	13 participants	2 participants
Efficacy of Drug Combination as Therapy for Myeloma (Overall Response Rate) Other Response (progression, stable disease, etc)	1 participants	6 participants

SECONDARY outcome

Timeframe: Occurred after mobilization, and prior to Stem cell transplant; a 7 day limit was imposed on stem cell collection

This is the yield of CD34+ stem cells collection after high dose cyclophosphamide.

Outcome measures

Measure	Treatment Arm - Post Mobilization n=27 Participants This is the response rate assessed for patients after their bortezomib-based mobilization.	Treatment Arm - Responses Prior to Mobilization This is the overall best response rate (ORR, ≥PR, as measured by ≥50% reduction in M-protein) to DoVeD therapy from post-primary induction (pre-DoVeD).
Yield of CD34+ Stem Cells	23.2 10^6 cells/kg Interval 6.8 to 294.2	—

SECONDARY outcome

Timeframe: Date of progression, assessed from start of trial to Final data cut off date (15 April 2011)

Response was assessed using IMWG guidelines, which for progressive disease are as follows:

Increase of > 25% from lowest response value in any one or more of the following:

• Serum M-component and/or (the absolute increase must be > 0.5 g/dL)*
• Urine M-component and/or (the absolute increase must be > 200 mg/24 h)
• Only in patients without measurable serum and urine M-protein levels; the difference between involved and uninvolved FLC levels. The absolute increase must be > 10 mg/dL
• Bone marrow plasma cell percentage; the absolute percentage must be > 10%
• 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 hypercalcaemia (corrected serum calcium > 11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder IF starting M protein component is > 5g/dL, then absolute increase of 1g is sufficient for progression.

Outcome measures

Measure	Treatment Arm - Post Mobilization n=38 Participants This is the response rate assessed for patients after their bortezomib-based mobilization.	Treatment Arm - Responses Prior to Mobilization This is the overall best response rate (ORR, ≥PR, as measured by ≥50% reduction in M-protein) to DoVeD therapy from post-primary induction (pre-DoVeD).
Progression Free Survival	46.6 months Interval 6.4 to 68.8	—

Adverse Events

Treatment Arm (All Patients)

Serious events: 1 serious events

Other events: 38 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment Arm (All Patients) n=38 participants at risk Bortezomib, Dexamethasone, Pegylated Liposomal Doxorubicin, Cyclophosphamide: Bortezomib 1.3 mg/m2 days 1, 4, 8, 11 (initial cycles) Dexamethasone 40 mg Days 1-4, 8-11, 15-18 (initial cycles) Doxil 30 mg/m2 Day 4 of subsequent cycles
Gastrointestinal disorders diarrhea	2.6% 1/38 • Safety was monitored throughout the study, from start of study until when patients were removed (for either progression, toxicity, or to get a HD-SCT, which occurred up to 1 year after start of treatment). Safety was monitored throughout the study and adverse events (AEs) were graded by NCI-CTCAE version 3.0.

Other adverse events

Measure	Treatment Arm (All Patients) n=38 participants at risk Bortezomib, Dexamethasone, Pegylated Liposomal Doxorubicin, Cyclophosphamide: Bortezomib 1.3 mg/m2 days 1, 4, 8, 11 (initial cycles) Dexamethasone 40 mg Days 1-4, 8-11, 15-18 (initial cycles) Doxil 30 mg/m2 Day 4 of subsequent cycles
General disorders dizziness	10.5% 4/38 • Safety was monitored throughout the study, from start of study until when patients were removed (for either progression, toxicity, or to get a HD-SCT, which occurred up to 1 year after start of treatment). Safety was monitored throughout the study and adverse events (AEs) were graded by NCI-CTCAE version 3.0.
Psychiatric disorders insomnia	5.3% 2/38 • Safety was monitored throughout the study, from start of study until when patients were removed (for either progression, toxicity, or to get a HD-SCT, which occurred up to 1 year after start of treatment). Safety was monitored throughout the study and adverse events (AEs) were graded by NCI-CTCAE version 3.0.
Psychiatric disorders depression	15.8% 6/38 • Safety was monitored throughout the study, from start of study until when patients were removed (for either progression, toxicity, or to get a HD-SCT, which occurred up to 1 year after start of treatment). Safety was monitored throughout the study and adverse events (AEs) were graded by NCI-CTCAE version 3.0.
Psychiatric disorders anxiety	7.9% 3/38 • Safety was monitored throughout the study, from start of study until when patients were removed (for either progression, toxicity, or to get a HD-SCT, which occurred up to 1 year after start of treatment). Safety was monitored throughout the study and adverse events (AEs) were graded by NCI-CTCAE version 3.0.
Psychiatric disorders irritability	7.9% 3/38 • Safety was monitored throughout the study, from start of study until when patients were removed (for either progression, toxicity, or to get a HD-SCT, which occurred up to 1 year after start of treatment). Safety was monitored throughout the study and adverse events (AEs) were graded by NCI-CTCAE version 3.0.
Psychiatric disorders nervousness	7.9% 3/38 • Safety was monitored throughout the study, from start of study until when patients were removed (for either progression, toxicity, or to get a HD-SCT, which occurred up to 1 year after start of treatment). Safety was monitored throughout the study and adverse events (AEs) were graded by NCI-CTCAE version 3.0.
Psychiatric disorders confusion	7.9% 3/38 • Safety was monitored throughout the study, from start of study until when patients were removed (for either progression, toxicity, or to get a HD-SCT, which occurred up to 1 year after start of treatment). Safety was monitored throughout the study and adverse events (AEs) were graded by NCI-CTCAE version 3.0.
Skin and subcutaneous tissue disorders dry skin	7.9% 3/38 • Safety was monitored throughout the study, from start of study until when patients were removed (for either progression, toxicity, or to get a HD-SCT, which occurred up to 1 year after start of treatment). Safety was monitored throughout the study and adverse events (AEs) were graded by NCI-CTCAE version 3.0.
Respiratory, thoracic and mediastinal disorders pneumonia	5.3% 2/38 • Safety was monitored throughout the study, from start of study until when patients were removed (for either progression, toxicity, or to get a HD-SCT, which occurred up to 1 year after start of treatment). Safety was monitored throughout the study and adverse events (AEs) were graded by NCI-CTCAE version 3.0.
Respiratory, thoracic and mediastinal disorders cough	31.6% 12/38 • Safety was monitored throughout the study, from start of study until when patients were removed (for either progression, toxicity, or to get a HD-SCT, which occurred up to 1 year after start of treatment). Safety was monitored throughout the study and adverse events (AEs) were graded by NCI-CTCAE version 3.0.
Respiratory, thoracic and mediastinal disorders sinusitis	5.3% 2/38 • Safety was monitored throughout the study, from start of study until when patients were removed (for either progression, toxicity, or to get a HD-SCT, which occurred up to 1 year after start of treatment). Safety was monitored throughout the study and adverse events (AEs) were graded by NCI-CTCAE version 3.0.
Respiratory, thoracic and mediastinal disorders shortness of breath	5.3% 2/38 • Safety was monitored throughout the study, from start of study until when patients were removed (for either progression, toxicity, or to get a HD-SCT, which occurred up to 1 year after start of treatment). Safety was monitored throughout the study and adverse events (AEs) were graded by NCI-CTCAE version 3.0.
Respiratory, thoracic and mediastinal disorders nasal congestion	15.8% 6/38 • Safety was monitored throughout the study, from start of study until when patients were removed (for either progression, toxicity, or to get a HD-SCT, which occurred up to 1 year after start of treatment). Safety was monitored throughout the study and adverse events (AEs) were graded by NCI-CTCAE version 3.0.
Ear and labyrinth disorders hearing impariment	5.3% 2/38 • Safety was monitored throughout the study, from start of study until when patients were removed (for either progression, toxicity, or to get a HD-SCT, which occurred up to 1 year after start of treatment). Safety was monitored throughout the study and adverse events (AEs) were graded by NCI-CTCAE version 3.0.
General disorders epistaxis	7.9% 3/38 • Safety was monitored throughout the study, from start of study until when patients were removed (for either progression, toxicity, or to get a HD-SCT, which occurred up to 1 year after start of treatment). Safety was monitored throughout the study and adverse events (AEs) were graded by NCI-CTCAE version 3.0.
Ear and labyrinth disorders sore throat	5.3% 2/38 • Safety was monitored throughout the study, from start of study until when patients were removed (for either progression, toxicity, or to get a HD-SCT, which occurred up to 1 year after start of treatment). Safety was monitored throughout the study and adverse events (AEs) were graded by NCI-CTCAE version 3.0.
Eye disorders blurred vision	34.2% 13/38 • Safety was monitored throughout the study, from start of study until when patients were removed (for either progression, toxicity, or to get a HD-SCT, which occurred up to 1 year after start of treatment). Safety was monitored throughout the study and adverse events (AEs) were graded by NCI-CTCAE version 3.0.
Cardiac disorders chest pain	5.3% 2/38 • Safety was monitored throughout the study, from start of study until when patients were removed (for either progression, toxicity, or to get a HD-SCT, which occurred up to 1 year after start of treatment). Safety was monitored throughout the study and adverse events (AEs) were graded by NCI-CTCAE version 3.0.
Cardiac disorders hypertension	7.9% 3/38 • Safety was monitored throughout the study, from start of study until when patients were removed (for either progression, toxicity, or to get a HD-SCT, which occurred up to 1 year after start of treatment). Safety was monitored throughout the study and adverse events (AEs) were graded by NCI-CTCAE version 3.0.
Musculoskeletal and connective tissue disorders myopathy	13.2% 5/38 • Safety was monitored throughout the study, from start of study until when patients were removed (for either progression, toxicity, or to get a HD-SCT, which occurred up to 1 year after start of treatment). Safety was monitored throughout the study and adverse events (AEs) were graded by NCI-CTCAE version 3.0.
Musculoskeletal and connective tissue disorders pain in extremity	10.5% 4/38 • Safety was monitored throughout the study, from start of study until when patients were removed (for either progression, toxicity, or to get a HD-SCT, which occurred up to 1 year after start of treatment). Safety was monitored throughout the study and adverse events (AEs) were graded by NCI-CTCAE version 3.0.
Musculoskeletal and connective tissue disorders muscle weakness	18.4% 7/38 • Safety was monitored throughout the study, from start of study until when patients were removed (for either progression, toxicity, or to get a HD-SCT, which occurred up to 1 year after start of treatment). Safety was monitored throughout the study and adverse events (AEs) were graded by NCI-CTCAE version 3.0.
Musculoskeletal and connective tissue disorders cramping	5.3% 2/38 • Safety was monitored throughout the study, from start of study until when patients were removed (for either progression, toxicity, or to get a HD-SCT, which occurred up to 1 year after start of treatment). Safety was monitored throughout the study and adverse events (AEs) were graded by NCI-CTCAE version 3.0.
Musculoskeletal and connective tissue disorders back pain	18.4% 7/38 • Safety was monitored throughout the study, from start of study until when patients were removed (for either progression, toxicity, or to get a HD-SCT, which occurred up to 1 year after start of treatment). Safety was monitored throughout the study and adverse events (AEs) were graded by NCI-CTCAE version 3.0.
General disorders weight gain	7.9% 3/38 • Safety was monitored throughout the study, from start of study until when patients were removed (for either progression, toxicity, or to get a HD-SCT, which occurred up to 1 year after start of treatment). Safety was monitored throughout the study and adverse events (AEs) were graded by NCI-CTCAE version 3.0.
General disorders fatigue	18.4% 7/38 • Safety was monitored throughout the study, from start of study until when patients were removed (for either progression, toxicity, or to get a HD-SCT, which occurred up to 1 year after start of treatment). Safety was monitored throughout the study and adverse events (AEs) were graded by NCI-CTCAE version 3.0.
General disorders dry mouth	5.3% 2/38 • Safety was monitored throughout the study, from start of study until when patients were removed (for either progression, toxicity, or to get a HD-SCT, which occurred up to 1 year after start of treatment). Safety was monitored throughout the study and adverse events (AEs) were graded by NCI-CTCAE version 3.0.
General disorders fever	7.9% 3/38 • Safety was monitored throughout the study, from start of study until when patients were removed (for either progression, toxicity, or to get a HD-SCT, which occurred up to 1 year after start of treatment). Safety was monitored throughout the study and adverse events (AEs) were graded by NCI-CTCAE version 3.0.
Vascular disorders edema	5.3% 2/38 • Safety was monitored throughout the study, from start of study until when patients were removed (for either progression, toxicity, or to get a HD-SCT, which occurred up to 1 year after start of treatment). Safety was monitored throughout the study and adverse events (AEs) were graded by NCI-CTCAE version 3.0.
General disorders headache	5.3% 2/38 • Safety was monitored throughout the study, from start of study until when patients were removed (for either progression, toxicity, or to get a HD-SCT, which occurred up to 1 year after start of treatment). Safety was monitored throughout the study and adverse events (AEs) were graded by NCI-CTCAE version 3.0.
General disorders taste alteration	13.2% 5/38 • Safety was monitored throughout the study, from start of study until when patients were removed (for either progression, toxicity, or to get a HD-SCT, which occurred up to 1 year after start of treatment). Safety was monitored throughout the study and adverse events (AEs) were graded by NCI-CTCAE version 3.0.
Gastrointestinal disorders diarrhea	23.7% 9/38 • Safety was monitored throughout the study, from start of study until when patients were removed (for either progression, toxicity, or to get a HD-SCT, which occurred up to 1 year after start of treatment). Safety was monitored throughout the study and adverse events (AEs) were graded by NCI-CTCAE version 3.0.
Gastrointestinal disorders nausea	13.2% 5/38 • Safety was monitored throughout the study, from start of study until when patients were removed (for either progression, toxicity, or to get a HD-SCT, which occurred up to 1 year after start of treatment). Safety was monitored throughout the study and adverse events (AEs) were graded by NCI-CTCAE version 3.0.
Nervous system disorders peripheral neuropathy (sensory)	73.7% 28/38 • Safety was monitored throughout the study, from start of study until when patients were removed (for either progression, toxicity, or to get a HD-SCT, which occurred up to 1 year after start of treatment). Safety was monitored throughout the study and adverse events (AEs) were graded by NCI-CTCAE version 3.0.
Nervous system disorders tremor	26.3% 10/38 • Safety was monitored throughout the study, from start of study until when patients were removed (for either progression, toxicity, or to get a HD-SCT, which occurred up to 1 year after start of treatment). Safety was monitored throughout the study and adverse events (AEs) were graded by NCI-CTCAE version 3.0.
General disorders cough	7.9% 3/38 • Safety was monitored throughout the study, from start of study until when patients were removed (for either progression, toxicity, or to get a HD-SCT, which occurred up to 1 year after start of treatment). Safety was monitored throughout the study and adverse events (AEs) were graded by NCI-CTCAE version 3.0.
Infections and infestations fever	7.9% 3/38 • Safety was monitored throughout the study, from start of study until when patients were removed (for either progression, toxicity, or to get a HD-SCT, which occurred up to 1 year after start of treatment). Safety was monitored throughout the study and adverse events (AEs) were graded by NCI-CTCAE version 3.0.
Blood and lymphatic system disorders thrombocytopenia	15.8% 6/38 • Safety was monitored throughout the study, from start of study until when patients were removed (for either progression, toxicity, or to get a HD-SCT, which occurred up to 1 year after start of treatment). Safety was monitored throughout the study and adverse events (AEs) were graded by NCI-CTCAE version 3.0.
Blood and lymphatic system disorders afebrile neutropenia	5.3% 2/38 • Safety was monitored throughout the study, from start of study until when patients were removed (for either progression, toxicity, or to get a HD-SCT, which occurred up to 1 year after start of treatment). Safety was monitored throughout the study and adverse events (AEs) were graded by NCI-CTCAE version 3.0.
Blood and lymphatic system disorders anemia	13.2% 5/38 • Safety was monitored throughout the study, from start of study until when patients were removed (for either progression, toxicity, or to get a HD-SCT, which occurred up to 1 year after start of treatment). Safety was monitored throughout the study and adverse events (AEs) were graded by NCI-CTCAE version 3.0.
Gastrointestinal disorders abdominal pain	15.8% 6/38 • Safety was monitored throughout the study, from start of study until when patients were removed (for either progression, toxicity, or to get a HD-SCT, which occurred up to 1 year after start of treatment). Safety was monitored throughout the study and adverse events (AEs) were graded by NCI-CTCAE version 3.0.
Gastrointestinal disorders dyspepsia	13.2% 5/38 • Safety was monitored throughout the study, from start of study until when patients were removed (for either progression, toxicity, or to get a HD-SCT, which occurred up to 1 year after start of treatment). Safety was monitored throughout the study and adverse events (AEs) were graded by NCI-CTCAE version 3.0.
Metabolism and nutrition disorders anorexia	5.3% 2/38 • Safety was monitored throughout the study, from start of study until when patients were removed (for either progression, toxicity, or to get a HD-SCT, which occurred up to 1 year after start of treatment). Safety was monitored throughout the study and adverse events (AEs) were graded by NCI-CTCAE version 3.0.
Gastrointestinal disorders constipation	39.5% 15/38 • Safety was monitored throughout the study, from start of study until when patients were removed (for either progression, toxicity, or to get a HD-SCT, which occurred up to 1 year after start of treatment). Safety was monitored throughout the study and adverse events (AEs) were graded by NCI-CTCAE version 3.0.
Gastrointestinal disorders increased appetite	5.3% 2/38 • Safety was monitored throughout the study, from start of study until when patients were removed (for either progression, toxicity, or to get a HD-SCT, which occurred up to 1 year after start of treatment). Safety was monitored throughout the study and adverse events (AEs) were graded by NCI-CTCAE version 3.0.
Gastrointestinal disorders bloating	7.9% 3/38 • Safety was monitored throughout the study, from start of study until when patients were removed (for either progression, toxicity, or to get a HD-SCT, which occurred up to 1 year after start of treatment). Safety was monitored throughout the study and adverse events (AEs) were graded by NCI-CTCAE version 3.0.
Nervous system disorders hand and foot syndrome	18.4% 7/38 • Safety was monitored throughout the study, from start of study until when patients were removed (for either progression, toxicity, or to get a HD-SCT, which occurred up to 1 year after start of treatment). Safety was monitored throughout the study and adverse events (AEs) were graded by NCI-CTCAE version 3.0.

Additional Information

Jennifer Hess

Weill Cornell Medical College

Phone: 6469629440

Email: jmh2004@med.cornell.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60