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Trial record 20 of 794 for:    LENALIDOMIDE AND cells

Sonidegib and Lenalidomide After Stem Cell Transplant in Treating Patients With Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT02086552
Recruitment Status : Active, not recruiting
First Posted : March 13, 2014
Results First Posted : May 29, 2019
Last Update Posted : May 29, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Mayo Clinic

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Recurrent Plasma Cell Myeloma
Refractory Plasma Cell Myeloma
Interventions Other: Laboratory Biomarker Analysis
Drug: Lenalidomide
Drug: Sonidegib
Enrollment 28
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (Sonidegib, Lenalidomide)
Hide Arm/Group Description Patients receive 400 mg sonidegib PO QD on days 1-28 and 10 mg lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.
Period Title: Overall Study
Started 28
Completed 27
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Arm/Group Title Treatment (Sonidegib, Lenalidomide)
Hide Arm/Group Description Patients receive 400 mg sonidegib PO QD on days 1-28 and 10 mg lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Baseline Participants 28
Hide Baseline Analysis Population Description
All patients registered to treatment were used to evaluate baseline characteristics.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 28 participants
59.5
(43 to 74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
Female
13
  46.4%
Male
15
  53.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
24
  85.7%
Unknown or Not Reported
4
  14.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   3.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
27
  96.4%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 28 participants
28
1.Primary Outcome
Title Complete Response, Assessed Using the International Myeloma Working Group (IMWG) Uniform Response Criteria
Hide Description

A comfirmed Complete Response (CR) is defined as a CR noted as the objective status on 2 consecutive evaluations. To be categorized as a CR, patients must exhibit the following: >

  • Negative immunofixation of serum and urine c, and >
  • Disappearance of any soft tissue plasmacytoma, and >
  • <5% plasma cells in Bone Marrow, and >
  • If the only measurable disease is the serum free light chain (FLC), a normal FLC ratio. >

We are reporting the proportion of patients achieving a CR or higher divided by the total number of evaluable patients. > Exact binomial 95% confidence intervals for the true success proportion will be calculated.

Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 28 patients registered, one cancelled prior to treatment and 1 was ineligible due to protocol violation. Therefore 26 patients were used in this analysis.
Arm/Group Title Treatment (Sonidegib, Lenalidomide)
Hide Arm/Group Description:
Patients receive 400 mg sonidegib PO QD on days 1-28 and 10 mg lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 26
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of patients
0.48
(0.27 to 0.69)
2.Secondary Outcome
Title Overall Survival
Time Frame Time from SCT to death due to any cause, assessed up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All patients that began protocol treatment and were eligible were included in this endpoint.
Arm/Group Title Treatment (Sonidegib, Lenalidomide)
Hide Arm/Group Description:
Patients receive 400 mg sonidegib PO QD on days 1-28 and 10 mg lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 26
Median (95% Confidence Interval)
Unit of Measure: years
NA [1] 
(4.3 to NA)
[1]
Too few events have occurred to estimate the median and upper 95% confidence interval.
3.Secondary Outcome
Title Progression-free Survival (1 Year Survival Rate)
Hide Description The progression-free survival time is defined as the time from SCT to progression or death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier. Here, we are reporting the proportion of patients that have not had a PFS event one year after SCT.
Time Frame Time from SCT to progression or death due to any cause, assessed at 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
All patients that were treated and evaluable were included in this endpoint.
Arm/Group Title Treatment (Sonidegib, Lenalidomide)
Hide Arm/Group Description:
Patients receive 400 mg sonidegib PO QD on days 1-28 and 10 mg lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 26
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
0.88
(.76 to 100)
4.Secondary Outcome
Title Progression-free Survival
Hide Description The progression-free survival time is defined as the time from SCT to progression or death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier. Here, we are reporting the proportion of patients that have not had a PFS event two years after SCT.
Time Frame Time from SCT to progression or death due to any cause, assessed at 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All patients that began protocol treatment and were evaluable were included in this endpoint.
Arm/Group Title Treatment (Sonidegib, Lenalidomide)
Hide Arm/Group Description:
Patients receive 400 mg sonidegib PO QD on days 1-28 and 10 mg lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 26
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
0.76
(0.61 to 0.94)
5.Other Pre-specified Outcome
Title Proportion of Patients Who Achieve MRD Negative Status
Hide Description Exact binomial 95% confidence intervals for the true MRD negative rate will be calculated.
Time Frame Up to 3 years
Outcome Measure Data Not Reported
Time Frame Adverse events were collected at the end of each 28-day cycle, for up to 18 cycles.
Adverse Event Reporting Description Adverse events were collected systematically at the end of each 28-day cycle, for up to 18 cycles.
 
Arm/Group Title Treatment (Sonidegib, Lenalidomide)
Hide Arm/Group Description Patients receive 400 mg sonidegib PO QD on days 1-28 and 10 mg lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.
All-Cause Mortality
Treatment (Sonidegib, Lenalidomide)
Affected / at Risk (%)
Total   0/27 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Sonidegib, Lenalidomide)
Affected / at Risk (%) # Events
Total   5/27 (18.52%)    
Blood and lymphatic system disorders   
Febrile neutropenia  1  1/27 (3.70%)  1
Gastrointestinal disorders   
Nausea  1  1/27 (3.70%)  1
Infections and infestations   
Lung infection  1  1/27 (3.70%)  1
Nervous system disorders   
Syncope  1  1/27 (3.70%)  1
Renal and urinary disorders   
Acute kidney injury  1  1/27 (3.70%)  1
Hematuria  1  1/27 (3.70%)  1
Vascular disorders   
Thromboembolic event  1  1/27 (3.70%)  1
1
Term from vocabulary, MedDRA 12
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment (Sonidegib, Lenalidomide)
Affected / at Risk (%) # Events
Total   27/27 (100.00%)    
Blood and lymphatic system disorders   
Anemia  1  3/27 (11.11%)  9
Febrile neutropenia  1  1/27 (3.70%)  1
Ear and labyrinth disorders   
Tinnitus  1  2/27 (7.41%)  18
Eye disorders   
Blurred vision  1  1/27 (3.70%)  3
Gastrointestinal disorders   
Abdominal pain  1  1/27 (3.70%)  1
Constipation  1  10/27 (37.04%)  46
Diarrhea  1  20/27 (74.07%)  147
Gastritis  1  1/27 (3.70%)  2
Vomiting  1  10/27 (37.04%)  13
General disorders   
Fatigue  1  25/27 (92.59%)  248
Infections and infestations   
Bladder infection  1  1/27 (3.70%)  1
Corneal infection  1  1/27 (3.70%)  1
Infections and infestations - Other, specify  1  2/27 (7.41%)  5
Sinusitis  1  1/27 (3.70%)  1
Investigations   
Alanine aminotransferase increased  1  1/27 (3.70%)  1
Alkaline phosphatase increased  1  2/27 (7.41%)  2
CPK increased  1  1/27 (3.70%)  1
Lymphocyte count decreased  1  5/27 (18.52%)  23
Neutrophil count decreased  1  23/27 (85.19%)  133
Platelet count decreased  1  18/27 (66.67%)  85
Weight loss  1  5/27 (18.52%)  12
White blood cell decreased  1  19/27 (70.37%)  107
Metabolism and nutrition disorders   
Anorexia  1  3/27 (11.11%)  4
Dehydration  1  1/27 (3.70%)  1
Musculoskeletal and connective tissue disorders   
Arthralgia  1  2/27 (7.41%)  19
Musculoskeletal and connective tissue disorder - Other, specify  1  4/27 (14.81%)  16
Myalgia  1  19/27 (70.37%)  146
Nervous system disorders   
Dysgeusia  1  12/27 (44.44%)  44
Headache  1  1/27 (3.70%)  3
Peripheral sensory neuropathy  1  20/27 (74.07%)  187
Respiratory, thoracic and mediastinal disorders   
Cough  1  1/27 (3.70%)  1
Skin and subcutaneous tissue disorders   
Alopecia  1  5/27 (18.52%)  11
Dry skin  1  1/27 (3.70%)  2
Rash maculo-papular  1  14/27 (51.85%)  29
Skin and subcutaneous tissue disorders - Other, specify  1  3/27 (11.11%)  3
Vascular disorders   
Hot flashes  1  2/27 (7.41%)  7
Hypertension  1  1/27 (3.70%)  1
Thromboembolic event  1  2/27 (7.41%)  10
1
Term from vocabulary, MedDRA 12
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Francis K Buadi, MD
Organization: Mayo Clinic
Phone: 507/284-2511
EMail: Kumar.Shaji@mayo.edu
Layout table for additonal information
Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT02086552     History of Changes
Other Study ID Numbers: MC128B
NCI-2014-00170 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
MC128B ( Other Identifier: Mayo Clinic )
P30CA015083 ( U.S. NIH Grant/Contract )
First Submitted: March 11, 2014
First Posted: March 13, 2014
Results First Submitted: May 6, 2019
Results First Posted: May 29, 2019
Last Update Posted: May 29, 2019