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Trial record 71 of 389 for:    CLARITHROMYCIN

Lenalidomide, Dexamethasone, and Clarithromycin in Treating Patients Who Have Undergone Stem Cell Transplant for Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT00445692
Recruitment Status : Completed
First Posted : March 9, 2007
Results First Posted : March 21, 2018
Last Update Posted : July 9, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Leona Holmberg, Fred Hutchinson Cancer Research Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions DS Stage I Plasma Cell Myeloma
DS Stage II Plasma Cell Myeloma
DS Stage III Plasma Cell Myeloma
Refractory Plasma Cell Myeloma
Interventions Drug: Clarithromycin
Drug: Dexamethasone
Drug: Lenalidomide
Enrollment 32
Recruitment Details  
Pre-assignment Details 32 patients were enrolled. 31 patients started therapy. 1 patient was consented but was deemed ineligible prior to therapy initiation.
Arm/Group Title Treatment (Clarithromycin, Dexamethasone, Lenalidomide)
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Patients receive clarithromycin orally twice daily and dexamethasone orally once a week. Treatment with clarithromycin and dexamethasone continues for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients also receive lenalidomide orally once daily on days 1-14. Courses with lenalidomide repeat every 21 days in the absence of disease progression or unacceptable toxicity. Lenalidomide is taken 4 hours or more after last dose of daily clarithromycin.

NOTE: *After one year of treatment, dexamethasone is tapered for an additional 4 weeks.

Clarithromycin: Given Orally (PO)

Dexamethasone: Given PO

Lenalidomide: Given PO

Period Title: Overall Study
Started 31
Completed 15
Not Completed 16
Reason Not Completed
Adverse Event             11
Lack of Efficacy             5
Arm/Group Title Treatment (Clarithromycin, Dexamethasone, Lenalidomide)
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Patients receive clarithromycin orally (PO) twice daily and dexamethasone PO once a week. Treatment with clarithromycin and dexamethasone continues for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients also receive lenalidomide PO once daily on days 1-14. Courses with lenalidomide repeat every 21 days in the absence of disease progression or unacceptable toxicity. Lenalidomide is taken 4 hours or more after last dose of daily clarithromycin.

NOTE: *After one year of treatment, dexamethasone is tapered for an additional 4 weeks.

Clarithromycin: Given Orally (PO)

Dexamethasone: Given PO

Lenalidomide: Given PO

Overall Number of Baseline Participants 31
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 31 participants
58
(28 to 72)
[1]
Measure Description: Age at transplant
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
Female
8
  25.8%
Male
23
  74.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
   6.5%
White
28
  90.3%
More than one race
0
   0.0%
Unknown or Not Reported
1
   3.2%
1.Primary Outcome
Title Episodes of Grade 3-4 Non Infectious, Non-dermatological or Non-neurological Toxicities, Episodes of Any Infections, Grade 3-4 Dermatological or Episodes of Grade 2-3 Peripheral Neuropathy Common Terminology Criteria for Adverse Events Version 3
Hide Description [Not Specified]
Time Frame First year of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Clarithromycin, Dexamethasone, Lenalidomide)
Hide Arm/Group Description:

Patients receive clarithromycin orally (PO) twice a day and dexamethasone PO once a week. Treatment with clarithromycin and dexamethasone continues for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients also receive lenalidomide PO daily on days 1-14. Courses with lenalidomide repeat every 21 days in the absence of disease progression or unacceptable toxicity. Lenalidomide is taken 4 hours or more after last dose of daily clarithromycin.

NOTE: *After one year of treatment, dexamethasone is tapered for an additional 4 weeks.

Clarithromycin: Given PO

Dexamethasone: Given PO

Lenalidomide: Given PO

Overall Number of Participants Analyzed 31
Measure Type: Number
Unit of Measure: episodes
Neutropenia 6
Thrombocytopenia 1
Deep venous thrombus/Pulmonary Embolism 1
Anemia 1
Pneumonia 4
Upper respiratory infections 12
Sinusitis/acute otitis media 3
Epiglottic appendagitis 1
Cellulitis 3
Clostridium difficile colitis 1
Vaginitis 3
Peripheral neuropathy 10
Dermal leukocytic vasculitis 1
Secondary cancer Acute Myeloid Leukemia 1
Re-occurrence of skin cancer 1
2.Primary Outcome
Title Time to Disease Progression
Hide Description [Not Specified]
Time Frame Up to 10.25 years
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Hide Analysis Population Description
Measured among the 20 patients who progressed
Arm/Group Title Treatment (Clarithromycin, Dexamethasone, Lenalidomide)
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Patients receive clarithromycin PO BID and dexamethasone PO once a week. Treatment with clarithromycin and dexamethasone continues for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients also receive lenalidomide PO QD on days 1-14. Courses with lenalidomide repeat every 21 days in the absence of disease progression or unacceptable toxicity. Lenalidomide is taken 4 hours or more after last dose of daily clarithromycin.

NOTE: *After one year of treatment, dexamethasone is tapered for an additional 4 weeks.

Clarithromycin: Given PO

Dexamethasone: Given PO

Lenalidomide: Given PO

Overall Number of Participants Analyzed 20
Median (Full Range)
Unit of Measure: months
30.5
(15 to 68.4)
3.Secondary Outcome
Title Survival
Hide Description number of patients alive or dead
Time Frame From date of transplant until the date of death from any cause, assessed up to 10.25 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Clarithromycin, Dexamethasone, Lenalidomide)
Hide Arm/Group Description:

Patients receive clarithromycin orally (PO) twice daily and dexamethasone PO once a week. Treatment with clarithromycin and dexamethasone continues for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients also receive lenalidomide PO once daily on days 1-14. Courses with lenalidomide repeat every 21 days in the absence of disease progression or unacceptable toxicity. Lenalidomide is taken 4 hours or more after last dose of daily clarithromycin.

NOTE: *After one year of treatment, dexamethasone is tapered for an additional 4 weeks.

Clarithromycin: Given Orally (PO)

Dexamethasone: Given PO

Lenalidomide: Given PO

Overall Number of Participants Analyzed 31
Measure Type: Count of Participants
Unit of Measure: Participants
Multiple meyloma deaths
10
  32.3%
Acute Myeloid Leukemia death
1
   3.2%
Lung cancer death
1
   3.2%
Heart attack death
1
   3.2%
Alive
18
  58.1%
Time Frame 10.25 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Clarithromycin, Dexamethasone, Lenalidomide)
Hide Arm/Group Description

Patients receive clarithromycin orally (PO) twice daily and dexamethasone PO once a week. Treatment with clarithromycin and dexamethasone continues for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients also receive lenalidomide PO once daily on days 1-14. Courses with lenalidomide repeat every 21 days in the absence of disease progression or unacceptable toxicity. Lenalidomide is taken 4 hours or more after last dose of daily clarithromycin.

NOTE: *After one year of treatment, dexamethasone is tapered for an additional 4 weeks.

Clarithromycin: Given Orally (PO)

Dexamethasone: Given PO

Lenalidomide: Given PO

All-Cause Mortality
Treatment (Clarithromycin, Dexamethasone, Lenalidomide)
Affected / at Risk (%)
Total   13/31 (41.94%) 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Clarithromycin, Dexamethasone, Lenalidomide)
Affected / at Risk (%)
Total   11/31 (35.48%) 
Blood and lymphatic system disorders   
Secondary cancer, Acute Myeloid Leukemia   1/31 (3.23%) 
Cardiac disorders   
Peripheral edema   1/31 (3.23%) 
Gastrointestinal disorders   
Ileus   1/31 (3.23%) 
Infections and infestations   
Upper Respiratory Syncytial Virus infection   1/31 (3.23%) 
Varicella-zoster virus pneumonia   1/31 (3.23%) 
Cellulitis   1/31 (3.23%) 
Pneumonia   2/31 (6.45%) 
Pneumocystis Carinii Pneumonia   1/31 (3.23%) 
H1N1 influenza / Streptococcus pneumonia   1/31 (3.23%) 
Upper respiratory syncytial viurs infection/Leukocytoclastic vasculitis   1/31 (3.23%) 
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 5%
Treatment (Clarithromycin, Dexamethasone, Lenalidomide)
Affected / at Risk (%)
Total   19/31 (61.29%) 
Infections and infestations   
upper respiratory infection   11/31 (35.48%) 
Investigations   
Neutropenia  [1]  9/31 (29.03%) 
Nervous system disorders   
Peripheral Neuropathy  [2]  10/31 (32.26%) 
Indicates events were collected by systematic assessment
[1]
Adverse Event reporting, only inclusive of events over Grade 1.
[2]
Based Adverse Event reporting, grade 2 -3
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: Leona A. Holmberg, MD, PhD
Organization: Fred Hutch Cancer Research Center
Phone: 206-667-6447
EMail: lholmber@fredhutch.org
Layout table for additonal information
Responsible Party: Leona Holmberg, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT00445692     History of Changes
Other Study ID Numbers: 2135.00
NCI-2010-02116 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2135.00p
2135
2135.00 ( Other Identifier: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium )
P30CA015704 ( U.S. NIH Grant/Contract )
First Submitted: March 7, 2007
First Posted: March 9, 2007
Results First Submitted: February 22, 2018
Results First Posted: March 21, 2018
Last Update Posted: July 9, 2018