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CompletedNCT00182663Updated Jun 26, 2017

Thalidomide, Dexamethasone, and Clarithromycin in Treating Patients With Multiple Myeloma Previously Treated With Transplant

A Phase 2 interventional study of clarithromycin and thalidomide in Refractory Multiple Myeloma, Stage I Multiple Myeloma and Stage II Multiple Myeloma, sponsored by Fred Hutchinson Cancer Center. Completed at 1 site in United States. Open to participants aged 14 Years and older. Per ClinicalTrials.gov, last updated 2017-06-26.

Sponsored by Fred Hutchinson Cancer Center · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
14 Years and older
Sex
All
01

Study summary

This phase II trial studies the side effects and how well giving thalidomide, dexamethasone, and clarithromycin together works in treating patients with multiple myeloma previously treated with transplant. Biological therapies, such as thalidomide and clarithromycin, may stimulate the immune system in different ways and stop cancer cells from growing. Dexamethasone also works in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving thalidomide together with dexamethasone and clarithromycin after a transplant may be an effective treatment for multiple myeloma

Read the detailed description

OBJECTIVES:

I. Evaluate the toxicity of the use of Thalidomide/Biaxin (Clarithromycin)/Dexamethasone as maintenance therapy after autologous/syngeneic transplant.

II. Evaluate the median time to disease progression. III. Evaluate survival.

OUTLINE:

Patients receive thalidomide orally (PO) once daily (QD), dexamethasone PO once weekly, and clarithromycin PO twice daily (BID). Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity. Treatment with thalidomide continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up periodically.

02

Conditions studied

  • Refractory Multiple Myeloma
  • Stage I Multiple Myeloma
  • Stage II Multiple Myeloma
  • Stage III Multiple Myeloma
03

In context

Multiple Myeloma

3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.

This study's planned enrollment of 30 is below the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

Fred Hutchinson Cancer Center is the lead sponsor of 537 studies on the registry; 79 are open to participants now.

Of its 57 completed or terminated interventional studies of FDA-regulated products, 45 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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 disease free survival or survival
  • Platelet count (transfusion independent) > 50,000 cells/mm\^3 for 5 calendar days after recovery from high dose
  • Absolute granulocyte count > 1500 cells/mm\^3 for 5 calendar days after recovery from high dose
  • Patients will start therapy between 30 days to 120 days after transplant
  • Willingness and ability to comply with Food and Drug Administration (FDA)-mandated S.T.E.P.S. (Celgene System for Thalidomide Education and Prescribing Safety) Program
  • Signing a written informed consent form

Exclusion criteria

Exclusion Criteria:

  • Karnofsky score less than 70
  • A left ventricular ejection fraction less than 45%; patients with congestive heart disease, history of myocardial infarction (MI), or coronary artery disease
  • Total bilirubin greater than 2 mg/ml (unless history of Gilbert's disease)
  • Serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT) > 2.5 x upper limit of normal
  • History of deep venous thrombus, arterial occlusions, or pulmonary emboli
  • 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 Thalidomide/Biaxin and Steroid without response
  • Patients allergic to Thalidomide, Biaxin or Dexamethasone
  • Referring physician not registered with S.T.E.P.S. program or unwilling to oversee the care of the patients on study and comply with the FDA-mandated S.T.E.P.S. Program
  • Patients unwilling to practice adequate forms of contraception if clinically indicated; 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 four weeks after stopping drugs
  • Patients with history of seizures
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Treatment (immunomodulator, antiangiogenesis, steroid therapy)

    Patients receive thalidomide PO QD dexamethasone PO once weekly, and clarithromycin PO BID. Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity. Treatment with thalidomide continues in the absence of disease progression or unacceptable toxicity.

    Drug: clarithromycin · Drug: thalidomide · Drug: dexamethasone

Interventions

  • Drugclarithromycin

    Given PO

    Also known as: Abbott-56268, Biaxin, CLARITH

  • Drugthalidomide

    Given PO

    Also known as: Kevadon, Synovir, THAL, Thalomid

  • Drugdexamethasone

    Given PO

    Also known as: Aeroseb-Dex, Decaderm, Decadron, DM, DXM

06

What researchers measure

Primary outcomes

  1. Toxicity of proposed treatment with clarithromycin, dexamethasone, and thalidomide

    Time frame: First 3 months of therapy

Secondary outcomes

  1. Time to disease progression

    Time frame: Up to 15 years

07

Study locations

1 site
  • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
    Seattle, Washington 98109, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 26, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00182663
Lead sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Sep 16, 2005
Start date
Jun 2003
Primary completion
Apr 2007
Last update
Jun 26, 2017

Study contacts

Leona Holmberg
principal investigator · Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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