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Trial record 2 of 2527 for:    "Plasma Cell Neoplasm"

Sorafenib, Lenalidomide, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT00687674
Recruitment Status : Terminated (Due to study design (and toxicity), this trial closed to accrual prior to opening the phase II portion.)
First Posted : June 2, 2008
Results First Posted : December 26, 2011
Last Update Posted : June 12, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Myeloma and Plasma Cell Neoplasm
Interventions Drug: dexamethasone
Drug: sorafenib tosylate
Drug: Lenalidomide
Enrollment 13
Recruitment Details Thirteen (13) participants were recruited at Mayo Clinic between August 2008 and March 2010.
Pre-assignment Details This was a phase I/II trial. A total of 13 participants were accrued, all to the phase I portion. This trial was terminated due to study design and toxicity during the phase I; therefore, the phase II portion will never open. No results from the phase II portion are available.
Arm/Group Title Sorafenib + Lenalidomide + Dexamethasone
Hide Arm/Group Description [Not Specified]
Period Title: Overall Study
Started 13
Completed 11
Not Completed 2
Arm/Group Title Sorafenib + Lenalidomide + Dexamethasone
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 13
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 13 participants
62
(42 to 77)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Female
6
  46.2%
Male
7
  53.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants
13
Prior Lenalidomide  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 13 participants
Yes 2
No 11
Prior Transplant  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 13 participants
Yes 12
No 1
1.Primary Outcome
Title Number of Participants With a Grade 3 and 4 Adverse Event (Phase I)
Hide Description

Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.

Description of Grades:

Grade 1: Mild Grade 2: Moderate Grade 3: Severe Grade 4: Life-threatening Grade 5: Death

Time Frame up to 3 years
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Hide Analysis Population Description
One participant refused further treatment prior to being assessed for adverse events.
Arm/Group Title Sorafenib + Lenalidomide + Dexamethasone
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: participants
11
2.Primary Outcome
Title Number of Participants Who Achieve a Confirmed Response (Partial Response [PR], Very Good PR [VGPR], Complete Response [CR], or Stringent CR [sCR]) (Phase II)
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Response that was confirmed on 2 consecutive evaluations during treatment

  • CR: Complete disappearance of M-protein from serum & urine on immunofixation, <5% plasma cells in bone marrow (BM)
  • sCR: CR plus normal FLC ratio & absence of clonal cells in BM
  • VGPR: >=90% reduction in serum M-component; Urine M-Component <100 mg per 24 hours; <=5% plasma cells in BM
  • PR: >= 50% reduction in serum M-Component and/or Urine M-Component >= 90% reduction or <200 mg per 24 hours; or >= 50% decrease in difference between involved and uninvolved FLC levels
Time Frame Duration on Treatment (up to 3 years)
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Hide Analysis Population Description
No participants proceeded to Phase II for evaluation.
Arm/Group Title Sorafenib + Lenalidomide + Dexamethasone
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Overall Survival (Phase II)
Hide Description Overall Survival (OS) was defined as the time from registration to death of any cause. Participants were followed for a maximum of 2 years from registration. The median OS with 95%CI was estimated using the Kaplan Meier method
Time Frame From registration to death (up to 3 years)
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Hide Analysis Population Description
No participants proceeded to Phase II for evaluation.
Arm/Group Title Sorafenib + Lenalidomide + Dexamethasone
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[Not Specified]
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Time to Disease Progression (Phase II)
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Time to disease progression (TTP) was defined as the time from registration to progression. The median TTP with 95%CI was estimated using the Kaplan Meier method.

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%)
Time Frame From registration to progression (up to 3 years)
Hide Outcome Measure Data
Hide Analysis Population Description
No participants proceeded to Phase II for evaluation.
Arm/Group Title Sorafenib + Lenalidomide + Dexamethasone
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Changes in Microvessel Density From Baseline to Post-treatment and Correlation With > Clinical Outcomes (Phase II)
Hide Description [Not Specified]
Time Frame Pre and Post treatment (up to 3 years)
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Change in Apoptosis Rate From Baseline to Post-treatment and Correlation With > Clinical Outcomes (Phase II)
Hide Description [Not Specified]
Time Frame Pre and Post treatment (up to 3 years)
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Plasma Cell Gene Expression Profiles and Correlation With > Clinical Outcomes
Hide Description [Not Specified]
Time Frame Post treatment
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Percentage of Stained Circulating Endothelial Cells and Endothelial Progenitor Cells and Correlation With Clinical Outcomes (Phase II
Hide Description [Not Specified]
Time Frame Post treatment
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Change in VEGF Expression Levels and Correlation With Clinical Outcomes (Phase II)
Hide Description [Not Specified]
Time Frame Post treatment
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sorafenib + Lenalidomide + Dexamethasone
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Sorafenib + Lenalidomide + Dexamethasone
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Sorafenib + Lenalidomide + Dexamethasone
Affected / at Risk (%) # Events
Total   3/13 (23.08%)    
Infections and infestations   
Pneumonia  1  1/13 (7.69%)  1
Investigations   
Leukopenia  1  1/13 (7.69%)  1
Skin and subcutaneous tissue disorders   
Rash  1  1/13 (7.69%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sorafenib + Lenalidomide + Dexamethasone
Affected / at Risk (%) # Events
Total   12/13 (92.31%)    
Blood and lymphatic system disorders   
Anemia  1  11/13 (84.62%)  53
Gastrointestinal disorders   
Diarrhea  1  4/13 (30.77%)  9
Nausea  1  2/13 (15.38%)  2
Oral cavity Mucositis/stomatitis (clinical exam)  1  2/13 (15.38%)  3
General disorders   
Fatigue  1  9/13 (69.23%)  63
Fever  1  1/13 (7.69%)  1
Pain  1  1/13 (7.69%)  6
Infections and infestations   
Infection without neutropenia  1  1/13 (7.69%)  1
Pneumonia  1  1/13 (7.69%)  2
Urinary tract infection  1  1/13 (7.69%)  1
Injury, poisoning and procedural complications   
Bruising  1  1/13 (7.69%)  5
Investigations   
Bilirubin  1  1/13 (7.69%)  1
Leukopenia  1  10/13 (76.92%)  64
Lymphocyte count decreased  1  1/13 (7.69%)  5
Neutrophil count decreased  1  10/13 (76.92%)  62
Platelet count decreased  1  10/13 (76.92%)  74
Metabolism and nutrition disorders   
Hyperglycemia  1  1/13 (7.69%)  1
Musculoskeletal and connective tissue disorders   
Back pain  1  1/13 (7.69%)  1
Myalgia  1  1/13 (7.69%)  4
Respiratory, thoracic and mediastinal disorders   
Nasal congestion  1  1/13 (7.69%)  7
Pulmonary  1  1/13 (7.69%)  9
Skin and subcutaneous tissue disorders   
Alopecia  1  1/13 (7.69%)  3
Hand-foot skin reaction  1  2/13 (15.38%)  2
Rash  1  7/13 (53.85%)  8
Vascular disorders   
Hypertension  1  4/13 (30.77%)  13
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Shaji Kumar
Organization: Mayo Clinic
Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT00687674     History of Changes
Other Study ID Numbers: CDR0000597065
P30CA015083 ( U.S. NIH Grant/Contract )
MC078A ( Other Identifier: Mayo Clinic )
07-006234 ( Other Identifier: Mayo Clinic IRB )
NCI-2009-01284 ( Registry Identifier: NCI-CTRP )
RV-MM-PI-0142 ( Other Identifier: Celgene Protocol )
SR06-933 ( Other Identifier: Bayer Protocol )
First Submitted: May 30, 2008
First Posted: June 2, 2008
Results First Submitted: November 23, 2011
Results First Posted: December 26, 2011
Last Update Posted: June 12, 2018