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NCT00445692 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2019-11-13

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

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

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outcome · POSTED

Time to Disease Progression

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outcome · POSTED

Survival

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * Any autologous or syngeneic patient who underwent high dose melphalan (\>= 140 mg/m\^2) therapy/peripheral blood stem cell (PBSC) or bone marrow (BM) rescue for any stage of multiple myeloma and did not participate in another clinical transplant trial which is also evaluating long-term disease free survival or survival * Platelet count (transfusion independent) \> 50,000 cells/mm\^3 and absolute granulocyte count \> 1500 cells/mm\^3 for 5 calendar days after recovery from high dose therapy * Patients should be between 30 days to 120 days after transplant * Willingness and ability to comply with Food and Drug Administration (FDA)-mandated REV ASSIST Program, Celgene System for Lenalidomide Education and Prescribing Safety * Signing a written informed consent form Exclusion Criteria: * Karnofsky score less than 70 * A left ventricular ejection fraction less than 45% immediately pre transplant; patients with congestive heart disease with transplant, history of myocardial infarction (MI), or history of coronary artery disease * Total bilirubin greater than 2 mg/ml (unless history of Gilbert's disease), serum glutamic-oxaloacetic transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) \> 2.5 x upper limit of normal * Calculated by Cockcroft-Gault formula or measured serum creatinine clearance \< 25 ml/minute * Pregnant and/or lactating females * Patients who cannot give informed consent * Patients with untreated systemic infection * Patients with history prior to transplant of treatment with combination therapy Lenalidomide/Biaxin and steroid without response * Patients allergic to lenalidomide, biaxin or dexamethasone * Referring physician not registered with REV ASSIST program or unwilling to oversee the care of the patients on study and comply with the FDA-mandated REV ASSIST Program * Patients unwilling to practice adequate forms of contraception if clinically indicated until 30 days after stopping therapy; male patients on study need to be consulted to use latex condoms (even if they have had a vasectomy) every time they have sex with a woman who is able to have children while they are being treated and for 30 days after stopping drugs * Patients with \>= grade 3 peripheral neuropathy * Prior history of uncontrollable side effects to dexamethasone therapy * A prior history of human immunodeficiency virus (HIV) positivity with pre-transplant evaluation
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. 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.
    intervention Names
    1. Drug: Clarithromycin
    2. Drug: Dexamethasone
    3. Drug: Lenalidomide
    label
    Treatment (clarithromycin, dexamethasone, lenalidomide)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Treatment (clarithromycin, dexamethasone, lenalidomide)
    description
    Given Orally (PO)
    name
    Clarithromycin
    other Names
    1. Abbott-56268
    2. Biaxin
    type
    DRUG
  2. arm Group Labels
    1. Treatment (clarithromycin, dexamethasone, lenalidomide)
    description
    Given PO
    name
    Dexamethasone
    other Names
    1. Aacidexam
    2. Adexone
    3. Aknichthol Dexa
    4. Alba-Dex
    5. Alin
    6. Alin Depot
    7. Alin Oftalmico
    8. Amplidermis
    9. Anemul mono
    10. Auricularum
    11. Auxiloson
    12. Baycuten
    type
    DRUG
  3. arm Group Labels
    1. Treatment (clarithromycin, dexamethasone, lenalidomide)
    description
    Given Orally (PO)
    name
    Lenalidomide
    other Names
    1. CC-5013
    2. CC5013
    3. CDC 501
    4. Revlimid
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
32
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    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
    time Frame
    First year of therapy
  2. description
    International Myeloma Working Group Uniform Response Criteria was used
    measure
    Time to Disease Progression
    time Frame
    Up to 10.25 years
secondary Outcomes
  1. description
    number of patients alive or dead
    measure
    Survival
    time Frame
    From date of transplant until the date of death from any cause, assessed up to 10.25 years
Full study description
brief Summary
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.
detailed Description
PRIMARY OBJECTIVES: I. Evaluate the toxicity of the use of lenalidomide/biaxin (clarithromycin)/dexamethasone as maintenance therapy after autologous/syngeneic transplant. II. Evaluate the median time to disease progression. III. Evaluate survival. OUTLINE: Patients receive clarithromycin orally (PO) twice daily (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 once daily (QD) on days 1-14. Courses with lenalidomide repeat every 21 days in the absence of disease progression or unacceptable toxicity. NOTE: \*After one year of treatment, dexamethasone is tapered for an additional 4 weeks. After completion of study treatment, patients are followed up periodically.
Source references
Source notices and limitations
    Discovery and provenance
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      occurrences
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        exact text
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        start
        0
      offset unit
      unicode_code_points
      query cond
      Plasma Cell Neoplasms
      query disease state id
      ds-plasma-cell-neoplasms
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-plasma-cell-neoplasms-000.json
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      source string sha256
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    Preserved source evidence · Not medical advice