NCT00445692

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

Completed Phase 2 Results posted Last updated 13 November 2019

What this trial tests

Phase 2 trial testing Clarithromycin in DS Stage I Plasma Cell Myeloma in 32 participants. Completed in 24 April 2017.

Timeline

10 January 2007

Primary endpoint
24 April 2017

24 April 2017

Quick facts

Lead sponsor	Fred Hutchinson Cancer Center
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	32
Start date	10 January 2007
Primary completion	24 April 2017
Estimated completion	24 April 2017
Sites	1 location across United States

Drugs / interventions tested

• Clarithromycin (clarithromycin) — full drug profile →
• Dexamethasone (dexamethasone) — full drug profile →
• Lenalidomide — full drug profile →

Conditions studied

• DS Stage I Plasma Cell Myeloma — all drugs for DS Stage I Plasma Cell Myeloma →
• DS Stage II Plasma Cell Myeloma — all drugs for DS Stage II Plasma Cell Myeloma →
• DS Stage III Plasma Cell Myeloma — all drugs for DS Stage III Plasma Cell Myeloma →
• Refractory Plasma Cell Myeloma — all drugs for Refractory Plasma Cell Myeloma →

Sponsor

Fred Hutchinson Cancer Center — full company profile →

Who can join

18 and older, any sex, with DS Stage I Plasma Cell Myeloma or DS Stage II Plasma Cell Myeloma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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 Primary · First year of therapy

Neutropenia

Group	Value	95% CI
Treatment (Clarithromycin, Dexamethasone, Lenalidomide)	6

Thrombocytopenia

Group	Value	95% CI
Treatment (Clarithromycin, Dexamethasone, Lenalidomide)	1

Deep venous thrombus/Pulmonary Embolism

Group	Value	95% CI
Treatment (Clarithromycin, Dexamethasone, Lenalidomide)	1

Anemia

Group	Value	95% CI
Treatment (Clarithromycin, Dexamethasone, Lenalidomide)	1

Pneumonia

Group	Value	95% CI
Treatment (Clarithromycin, Dexamethasone, Lenalidomide)	4

Upper respiratory infections

Group	Value	95% CI
Treatment (Clarithromycin, Dexamethasone, Lenalidomide)	12

Sinusitis/acute otitis media

Group	Value	95% CI
Treatment (Clarithromycin, Dexamethasone, Lenalidomide)	3

Epiglottic appendagitis

Group	Value	95% CI
Treatment (Clarithromycin, Dexamethasone, Lenalidomide)	1

Time to Disease Progression Primary · Up to 10.25 years

International Myeloma Working Group Uniform Response Criteria was used

Group	Value	95% CI
Treatment (Clarithromycin, Dexamethasone, Lenalidomide)	30.5	15 – 68.4

Survival Secondary · From date of transplant until the date of death from any cause, assessed up to 10.25 years

number of patients alive or dead

Group	Value	95% CI
Treatment (Clarithromycin, Dexamethasone, Lenalidomide)	10
Treatment (Clarithromycin, Dexamethasone, Lenalidomide)	1
Treatment (Clarithromycin, Dexamethasone, Lenalidomide)	1
Treatment (Clarithromycin, Dexamethasone, Lenalidomide)	1

Adverse events — posted to ClinicalTrials.gov

Time frame: 10.25 years. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment (Clarithromycin, Dexamethasone, Lenalidomide)

Serious: 11/31 (35%)

Deaths: 13/31

Serious adverse events (10 terms)

Reaction	System	Treatment (Clarithromycin,…
Pneumonia	Infections and infestations	—
Upper Respiratory Syncytial Virus infection	Infections and infestations	—
Varicella-zoster virus pneumonia	Infections and infestations	—
Cellulitis	Infections and infestations	—
Peripheral edema	Cardiac disorders	—
Pneumocystis Carinii Pneumonia	Infections and infestations	—
H1N1 influenza / Streptococcus pneumonia	Infections and infestations	—
Ileus	Gastrointestinal disorders	—
Secondary cancer, Acute Myeloid Leukemia	Blood and lymphatic system disorders	—
Upper respiratory syncytial viurs infection/Leukocytoclastic vasculitis	Infections and infestations	—

Other adverse events (6 terms — click to expand)

Reaction	System	Treatment (Clarithromycin,…
upper respiratory infection	Infections and infestations	—
Peripheral Neuropathy	Nervous system disorders	—
Neutropenia	Investigations	—
sinus/acute otitis	Infections and infestations	—
cellulitis	Infections and infestations	—
vaginitis	Infections and infestations	—

Most-reported serious reactions: Pneumonia, Upper Respiratory Syncytial Virus infection, Varicella-zoster virus pneumonia, Cellulitis, Peripheral edema, Pneumocystis Carinii Pneumonia, H1N1 influenza / Streptococcus pneumonia, Ileus.

Data from ClinicalTrials.gov NCT00445692 adverse events section.

Sponsor's own description

This phase II trial studies lenalidomide, dexamethasone, and clarithromycin in treating patients who have undergone stem cell transplant for multiple myeloma. Biological therapies, such as lenalidomide and clarithromycin, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with dexamethasone and clarithromycin may be an effective treatment for multiple myeloma.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Autophagy Modulators in Cancer Therapy.
   Buzun K, Gornowicz A, Lesyk R, Bielawski K, et al · · 2021 · cited 50× · PMID 34071600 · DOI 10.3390/ijms22115804
2. Targeting Autophagy with Natural Products as a Potential Therapeutic Approach for Cancer.
   Al-Bari MAA, Ito Y, Ahmed S, Radwan N, et al · · 2021 · cited 34× · PMID 34575981 · DOI 10.3390/ijms22189807