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Study of Decadron, Biaxin, and Pomalidomide in Relapsed/Refractory Myeloma

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ClinicalTrials.gov Identifier: NCT01159574
Recruitment Status : Active, not recruiting
First Posted : July 9, 2010
Results First Posted : April 12, 2017
Last Update Posted : June 5, 2018
Sponsor:
Collaborator:
Celgene
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Myeloma
Interventions Drug: dexamethasone
Drug: clarithromycin
Drug: Pomalidomide
Enrollment 121
Recruitment Details  
Pre-assignment Details  
Arm/Group Title All Patients
Hide Arm/Group Description

ClaPd therapy:

Dexamethasone (40mg ) will be given on days 1, 8, 15, 22 of a 28-day cycle. Clarithromycin (Biaxin®) will be given orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle.

Pomalidomide will be given 4mg daily for days 1-21 of each 28 day cycle. Dosing will be in the morning at approximately the same time each day.

dexamethasone: 40mg will be given on days 1, 8, 15, 22 of a 28-day cycle

clarithromycin: orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle

Pomalidomide: orally 4mg daily for days 1-21 of each 28 day cycle

Period Title: Treatment Phase
Started 121
Completed [1] 100
Not Completed 21
Reason Not Completed
non-evaluable/not included in analysis             1
Adverse Event             3
Death             6
Physician Decision             2
Withdrawal by Subject             7
still on treatment             2
[1]
Completion defined as those that were removed from treatment due to disease progression.
Period Title: Follow Up Phase
Started [1] 112
Completed 92 [2]
Not Completed 20
Reason Not Completed
Lost to Follow-up             2
still being followed for overall surviva             18
[1]
Follow-up includes all patients except those that passed away on treatment or were non-evaluable.
[2]
Completion defined as those that are no longer in long term follow up due to death.
Arm/Group Title All Patients
Hide Arm/Group Description

ClaPd therapy:

Dexamethasone (40mg ) will be given on days 1, 8, 15, 22 of a 28-day cycle. Clarithromycin (Biaxin®) will be given orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle.

Pomalidomide will be given 4mg daily for days 1-21 of each 28 day cycle. Dosing will be in the morning at approximately the same time each day.

dexamethasone: 40mg will be given on days 1, 8, 15, 22 of a 28-day cycle

clarithromycin: orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle

Pomalidomide: orally 4mg daily for days 1-21 of each 28 day cycle

Overall Number of Baseline Participants 120
Hide Baseline Analysis Population Description
121 subject signed consent; 1 subject was not considered to be evaluable and was not included in any analysis.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 120 participants
63
(42 to 87)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 120 participants
Female
62
  51.7%
Male
58
  48.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 120 participants
Hispanic or Latino
6
   5.0%
Not Hispanic or Latino
112
  93.3%
Unknown or Not Reported
2
   1.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 120 participants
American Indian or Alaska Native
0
   0.0%
Asian
8
   6.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
12
  10.0%
White
93
  77.5%
More than one race
0
   0.0%
Unknown or Not Reported
7
   5.8%
Hemoglobin  
Median (Full Range)
Unit of measure:  g/dL
Number Analyzed 120 participants
10.4
(6.4 to 14.6)
Range of Prior Therapies  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 120 participants
5
(3 to 15)
Beta-2 microglobulin at baseline (in mg/L)  
Median (Full Range)
Unit of measure:  mg/L
Number Analyzed 120 participants
35
(1.2 to 40.4)
lactage dehydrogenase at baseline (U/L)  
Median (Full Range)
Unit of measure:  U/l
Number Analyzed 120 participants
170.5
(79 to 1353)
1.Primary Outcome
Title Overall Response Rate
Hide Description Best response rate was recorded for all patients, using the IMWG criteria.
Time Frame from baseline to cycle with maximum response, which was achieved on average after 2 cycles
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Patients
Hide Arm/Group Description:

ClaPd therapy:

Dexamethasone (40mg ) will be given on days 1, 8, 15, 22 of a 28-day cycle. Clarithromycin (Biaxin®) will be given orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle.

Pomalidomide will be given 4mg daily for days 1-21 of each 28 day cycle. Dosing will be in the morning at approximately the same time each day.

dexamethasone: 40mg will be given on days 1, 8, 15, 22 of a 28-day cycle

clarithromycin: orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle

Pomalidomide: orally 4mg daily for days 1-21 of each 28 day cycle

Overall Number of Participants Analyzed 120
Measure Type: Count of Participants
Unit of Measure: Participants
stringent Complete Response
6
   5.0%
Complete Response
1
   0.8%
Very Good Partial Response
20
  16.7%
Partial Response
43
  35.8%
Minimal Response
8
   6.7%
stable disease
29
  24.2%
Not evaluable
3
   2.5%
progression of disease
10
   8.3%
2.Secondary Outcome
Title Time to Maximum Response, Expressed as Number of Cycles of Treatment to Maximum Response
Hide Description [Not Specified]
Time Frame From baseline to cycle of maximum response, which occurred on average after 2 cycles; 1 cycle = 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Patients
Hide Arm/Group Description:

ClaPd therapy:

Dexamethasone (40mg ) will be given on days 1, 8, 15, 22 of a 28-day cycle. Clarithromycin (Biaxin®) will be given orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle.

Pomalidomide will be given 4mg daily for days 1-21 of each 28 day cycle. Dosing will be in the morning at approximately the same time each day.

dexamethasone: 40mg will be given on days 1, 8, 15, 22 of a 28-day cycle

clarithromycin: orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle

Pomalidomide: orally 4mg daily for days 1-21 of each 28 day cycle

Overall Number of Participants Analyzed 120
Mean (Full Range)
Unit of Measure: cycles
2.19
(1 to 18)
3.Secondary Outcome
Title Time to Disease Progression (Progression Free Survival)
Hide Description [Not Specified]
Time Frame From start of treatment, to date of disease progression
Hide Outcome Measure Data
Hide Analysis Population Description
18 patients were removed from study for reasons other then disease progression; 2 patients are still receiving treatment.
Arm/Group Title All Patients
Hide Arm/Group Description:

ClaPd therapy:

Dexamethasone (40mg ) will be given on days 1, 8, 15, 22 of a 28-day cycle. Clarithromycin (Biaxin®) will be given orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle.

Pomalidomide will be given 4mg daily for days 1-21 of each 28 day cycle. Dosing will be in the morning at approximately the same time each day.

dexamethasone: 40mg will be given on days 1, 8, 15, 22 of a 28-day cycle

clarithromycin: orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle

Pomalidomide: orally 4mg daily for days 1-21 of each 28 day cycle

Overall Number of Participants Analyzed 100
Mean (Full Range)
Unit of Measure: days
272
(21 to 1430)
Time Frame Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse Event Reporting Description Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
 
Arm/Group Title All Patients
Hide Arm/Group Description

ClaPd therapy:

Dexamethasone (40mg ) will be given on days 1, 8, 15, 22 of a 28-day cycle. Clarithromycin (Biaxin®) will be given orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle.

Pomalidomide will be given 4mg daily for days 1-21 of each 28 day cycle. Dosing will be in the morning at approximately the same time each day.

dexamethasone: 40mg will be given on days 1, 8, 15, 22 of a 28-day cycle

clarithromycin: orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle

Pomalidomide: orally 4mg daily for days 1-21 of each 28 day cycle

All-Cause Mortality
All Patients
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
All Patients
Affected / at Risk (%) # Events
Total   59/120 (49.17%)    
Blood and lymphatic system disorders   
anemia *  3/120 (2.50%)  3
febrile neutropenia *  1/120 (0.83%)  1
neutropenia *  3/120 (2.50%)  3
pancytopenia *  1/120 (0.83%)  1
thrombocytopenia * 1  2/120 (1.67%)  2
Cardiac disorders   
atrial fibrillation *  1/120 (0.83%)  1
Gastrointestinal disorders   
bowel obstruction *  1/120 (0.83%)  1
diarrhea *  5/120 (4.17%)  5
diffuse small bowl ileus *  1/120 (0.83%)  1
nausea *  2/120 (1.67%)  2
vomiting *  5/120 (4.17%)  5
General disorders   
death *  1/120 (0.83%)  1
fall *  1/120 (0.83%)  1
fatigue *  1/120 (0.83%)  1
transient word finding difficulity *  1/120 (0.83%)  1
weakness (including associated pain/tiredness) *  2/120 (1.67%)  2
Infections and infestations   
cellulitis *  1/120 (0.83%)  1
cough *  1/120 (0.83%)  1
diverticullitis *  1/120 (0.83%)  1
fever *  4/120 (3.33%)  4
gastroenteritis *  1/120 (0.83%)  1
infection *  1/120 (0.83%)  1
lung infection *  15/120 (12.50%)  16
neutropenic fever *  4/120 (3.33%)  4
parainfluenza virus infection *  1/120 (0.83%)  1
renal insufficiency *  4/120 (3.33%)  4
rhinovirus *  1/120 (0.83%)  1
sepsis *  3/120 (2.50%)  3
skin infection (including cellulitis) *  3/120 (2.50%)  4
Investigations   
complications of MM (leading to death) *  1/120 (0.83%)  1
intrcranial bleed *  1/120 (0.83%)  1
Metabolism and nutrition disorders   
creatinine increased *  1/120 (0.83%)  1
dehydration *  6/120 (5.00%)  6
hypercalcemia *  1/120 (0.83%)  1
hyperglycemia *  1/120 (0.83%)  1
hyperkalemia *  1/120 (0.83%)  1
Musculoskeletal and connective tissue disorders   
back pain *  1/120 (0.83%)  1
chest pain *  1/120 (0.83%)  1
fracture *  4/120 (3.33%)  4
pain (hip, rib) *  1/120 (0.83%)  1
pain (rib) *  1/120 (0.83%)  1
lower back pain *  2/120 (1.67%)  2
muscle weakness *  2/120 (1.67%)  2
Nervous system disorders   
suspected seizure *  1/120 (0.83%)  1
Psychiatric disorders   
agitation *  1/120 (0.83%)  1
altered mental status *  1/120 (0.83%)  1
behavior changes *  1/120 (0.83%)  1
confusion *  2/120 (1.67%)  3
hallunication *  1/120 (0.83%)  1
syncopal episode *  2/120 (1.67%)  2
Renal and urinary disorders   
acute renal failure *  1/120 (0.83%)  1
chronic kidney insufficiency *  1/120 (0.83%)  1
Respiratory, thoracic and mediastinal disorders   
dyspnea *  3/120 (2.50%)  3
epistaxis *  2/120 (1.67%)  2
pulmonary emboli *  1/120 (0.83%)  1
Skin and subcutaneous tissue disorders   
rash *  1/120 (0.83%)  1
Vascular disorders   
hypotension *  3/120 (2.50%)  3
thromboembolic event *  2/120 (1.67%)  2
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, b
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
All Patients
Affected / at Risk (%) # Events
Total   120/120 (100.00%)    
Blood and lymphatic system disorders   
Anemia   74/120 (61.67%) 
Thrombocytopenia   85/120 (70.83%) 
Leukopenia   86/120 (71.67%) 
Lymphopenia   89/120 (74.17%) 
Neutropenia   99/120 (82.50%) 
Eye disorders   
blurry vision   18/120 (15.00%) 
Gastrointestinal disorders   
cramping   7/120 (5.83%) 
dry mouth   7/120 (5.83%) 
dehydration   8/120 (6.67%) 
bloating   12/120 (10.00%) 
abdominal pain/discomfort   13/120 (10.83%) 
flatulance   13/120 (10.83%) 
vomiting   15/120 (12.50%) 
dyspepsia   18/120 (15.00%) 
nausea   23/120 (19.17%) 
constipation   32/120 (26.67%) 
diarrhea   44/120 (36.67%) 
General disorders   
fall   10/120 (8.33%) 
generalized weakness   13/120 (10.83%) 
insomnia   36/120 (30.00%) 
fatigue   75/120 (62.50%) 
Infections and infestations   
Skin Infection   6/120 (5.00%) 
Thrush   6/120 (5.00%) 
UTI   7/120 (5.83%) 
Pneumonia   8/120 (6.67%) 
sore throat   11/120 (9.17%) 
fever   13/120 (10.83%) 
lung infection   19/120 (15.83%) 
cough   24/120 (20.00%) 
URI   27/120 (22.50%) 
Metabolism and nutrition disorders   
hypermagnesemia   8/120 (6.67%) 
hypernatremia   8/120 (6.67%) 
hypercalcemia   10/120 (8.33%) 
weight gain   10/120 (8.33%) 
weight loss   11/120 (9.17%) 
hyperkalemia   14/120 (11.67%) 
anorexia   17/120 (14.17%) 
elevated AST   19/120 (15.83%) 
Hyperbilirubinemia   23/120 (19.17%) 
Hypokalemia   23/120 (19.17%) 
Hypophosphatemia   31/120 (25.83%) 
elevated ALT   36/120 (30.00%) 
elevated ALK   36/120 (30.00%) 
increased creatinine   46/120 (38.33%) 
Hypomagnesemia   51/120 (42.50%) 
hyponatremia   62/120 (51.67%) 
hypocalcemia   66/120 (55.00%) 
Hypoalbuminemia   70/120 (58.33%) 
hypoglycemia   73/120 (60.83%) 
hyperglycemia   77/120 (64.17%) 
Musculoskeletal and connective tissue disorders   
bone pain   6/120 (5.00%) 
chest pain (muscular)   7/120 (5.83%) 
pain in general   11/120 (9.17%) 
pain in legs   11/120 (9.17%) 
hip pain   14/120 (11.67%) 
rib pain   15/120 (12.50%) 
shoulder pain   18/120 (15.00%) 
muscle spasms/cramps   22/120 (18.33%) 
muscle weakness   33/120 (27.50%) 
back pain   39/120 (32.50%) 
Nervous system disorders   
neuro mood   6/120 (5.00%) 
psychomotor agitation   6/120 (5.00%) 
confusion   7/120 (5.83%) 
agitation   8/120 (6.67%) 
Paresthesia   8/120 (6.67%) 
headache   14/120 (11.67%) 
anxiety/stress   17/120 (14.17%) 
depression   19/120 (15.83%) 
dysgeusia   19/120 (15.83%) 
dizziness / lightheaded   25/120 (20.83%) 
tremor   29/120 (24.17%) 
peripheral neuropathy   37/120 (30.83%) 
Renal and urinary disorders   
renal failure/insufficiency   6/120 (5.00%) 
Hyperuricemia   9/120 (7.50%) 
CKD   12/120 (10.00%) 
Respiratory, thoracic and mediastinal disorders   
epistaxis   6/120 (5.00%) 
hoarseness   8/120 (6.67%) 
postnasal drip   8/120 (6.67%) 
nasal congestion   11/120 (9.17%) 
Dyspnea   30/120 (25.00%) 
Skin and subcutaneous tissue disorders   
cushingoid   7/120 (5.83%) 
rash maculo papular   8/120 (6.67%) 
facial flushing   10/120 (8.33%) 
hyperhidrosis   10/120 (8.33%) 
rash   15/120 (12.50%) 
Vascular disorders   
Lower extremity DVT   7/120 (5.83%) 
bruising   9/120 (7.50%) 
edema   38/120 (31.67%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Jennifer Hess
Organization: Weill Cornell Medical College
Phone: 6469629440
Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01159574     History of Changes
Other Study ID Numbers: 1004011012
PO-MM-PI-0023 ( Other Grant/Funding Number: Celgene )
First Submitted: June 16, 2010
First Posted: July 9, 2010
Results First Submitted: February 28, 2017
Results First Posted: April 12, 2017
Last Update Posted: June 5, 2018