Trial Outcomes & Findings for Lenalidomide, Dexamethasone, and Clarithromycin in Treating Patients Who Have Undergone Stem Cell Transplant for Multiple Myeloma (NCT NCT00445692)
NCT ID: NCT00445692
Last Updated: 2019-11-13
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
32 participants
Primary outcome timeframe
First year of therapy
Results posted on
2019-11-13
Participant Flow
32 patients were enrolled. 31 patients started therapy. 1 patient was consented but was deemed ineligible prior to therapy initiation.
Participant milestones
| Measure |
Treatment (Clarithromycin, Dexamethasone, Lenalidomide)
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
|
|---|---|
|
Overall Study
STARTED
|
31
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
16
|
Reasons for withdrawal
| Measure |
Treatment (Clarithromycin, Dexamethasone, Lenalidomide)
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
|
|---|---|
|
Overall Study
Adverse Event
|
11
|
|
Overall Study
Lack of Efficacy
|
5
|
Baseline Characteristics
Lenalidomide, Dexamethasone, and Clarithromycin in Treating Patients Who Have Undergone Stem Cell Transplant for Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Treatment (Clarithromycin, Dexamethasone, Lenalidomide)
n=31 Participants
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
|
|---|---|
|
Age, Continuous
|
58 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 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
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: First year of therapyOutcome measures
| Measure |
Treatment (Clarithromycin, Dexamethasone, Lenalidomide)
n=31 Participants
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
|
|---|---|
|
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
Neutropenia
|
6 episodes
|
|
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
Thrombocytopenia
|
1 episodes
|
|
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
Deep venous thrombus/Pulmonary Embolism
|
1 episodes
|
|
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
Anemia
|
1 episodes
|
|
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
Pneumonia
|
4 episodes
|
|
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
Upper respiratory infections
|
12 episodes
|
|
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
Sinusitis/acute otitis media
|
3 episodes
|
|
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
Epiglottic appendagitis
|
1 episodes
|
|
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
Cellulitis
|
3 episodes
|
|
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
Clostridium difficile colitis
|
1 episodes
|
|
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
Vaginitis
|
3 episodes
|
|
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
Peripheral neuropathy
|
10 episodes
|
|
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
Dermal leukocytic vasculitis
|
1 episodes
|
|
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
Secondary cancer Acute Myeloid Leukemia
|
1 episodes
|
|
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
Re-occurrence of skin cancer
|
1 episodes
|
PRIMARY outcome
Timeframe: Up to 10.25 yearsPopulation: Measured among the 20 patients who progressed
International Myeloma Working Group Uniform Response Criteria was used
Outcome measures
| Measure |
Treatment (Clarithromycin, Dexamethasone, Lenalidomide)
n=20 Participants
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
|
|---|---|
|
Time to Disease Progression
|
30.5 months
Interval 15.0 to 68.4
|
SECONDARY outcome
Timeframe: From date of transplant until the date of death from any cause, assessed up to 10.25 yearsnumber of patients alive or dead
Outcome measures
| Measure |
Treatment (Clarithromycin, Dexamethasone, Lenalidomide)
n=31 Participants
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
|
|---|---|
|
Survival
Multiple meyloma deaths
|
10 Participants
|
|
Survival
Acute Myeloid Leukemia death
|
1 Participants
|
|
Survival
Lung cancer death
|
1 Participants
|
|
Survival
Heart attack death
|
1 Participants
|
|
Survival
Alive
|
18 Participants
|
Adverse Events
Treatment (Clarithromycin, Dexamethasone, Lenalidomide)
Serious events: 11 serious events
Other events: 19 other events
Deaths: 13 deaths
Serious adverse events
| Measure |
Treatment (Clarithromycin, Dexamethasone, Lenalidomide)
n=31 participants at risk
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
|
|---|---|
|
Infections and infestations
Upper Respiratory Syncytial Virus infection
|
3.2%
1/31 • 10.25 years
|
|
Infections and infestations
Varicella-zoster virus pneumonia
|
3.2%
1/31 • 10.25 years
|
|
Infections and infestations
Cellulitis
|
3.2%
1/31 • 10.25 years
|
|
Infections and infestations
Pneumonia
|
6.5%
2/31 • 10.25 years
|
|
Cardiac disorders
Peripheral edema
|
3.2%
1/31 • 10.25 years
|
|
Infections and infestations
Pneumocystis Carinii Pneumonia
|
3.2%
1/31 • 10.25 years
|
|
Infections and infestations
H1N1 influenza / Streptococcus pneumonia
|
3.2%
1/31 • 10.25 years
|
|
Gastrointestinal disorders
Ileus
|
3.2%
1/31 • 10.25 years
|
|
Blood and lymphatic system disorders
Secondary cancer, Acute Myeloid Leukemia
|
3.2%
1/31 • 10.25 years
|
|
Infections and infestations
Upper respiratory syncytial viurs infection/Leukocytoclastic vasculitis
|
3.2%
1/31 • 10.25 years
|
Other adverse events
| Measure |
Treatment (Clarithromycin, Dexamethasone, Lenalidomide)
n=31 participants at risk
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
|
|---|---|
|
Nervous system disorders
Peripheral Neuropathy
|
32.3%
10/31 • 10.25 years
|
|
Investigations
Neutropenia
|
29.0%
9/31 • 10.25 years
|
|
Infections and infestations
upper respiratory infection
|
35.5%
11/31 • 10.25 years
|
|
Infections and infestations
sinus/acute otitis
|
9.7%
3/31 • 10.25 years
|
|
Infections and infestations
cellulitis
|
9.7%
3/31 • 10.25 years
|
|
Infections and infestations
vaginitis
|
9.7%
3/31 • 10.25 years
|
Additional Information
Leona A. Holmberg, MD, PhD
Fred Hutch Cancer Research Center
Phone: 206-667-6447
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place