NCT00151203

Brief Summary

PRIMARY STUDY OBJECTIVES

  • To evaluate the efficacy of the combination of clarithromycin (Biaxin®), lenalidomide (Revlimid™), and dexamethasone (Decadron®) as an induction therapy for patients with newly diagnosed multiple myeloma (MM).
  • To evaluate the safety of the combination of clarithromycin, lenalidomide, and dexamethasone as an induction therapy for patients with newly diagnosed MM. SECONDARY STUDY OBJECTIVES
  • To examine the role of clarithromycin on the pharmacokinetic properties of dexamethasone and lenalidomide.
  • To examine the angiogenesis profile in untreated patients and in patients receiving induction therapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_2 multiple-myeloma

Timeline
Completed

Started Dec 2004

Longer than P75 for phase_2 multiple-myeloma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
13.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2020

Completed
Last Updated

May 27, 2021

Status Verified

May 1, 2021

Enrollment Period

2.3 years

First QC Date

September 6, 2005

Last Update Submit

May 26, 2021

Conditions

Multiple Myeloma

Keywords

newly diagnosed multiple myeloma

Outcome Measures

Primary Outcomes (1)

  • Response rate, time to maximum response, toxicities

    3 years

Interventions

Clarithromycin, Lenalidomide, DexamethasoneDRUG

Dexamethasone (Decadron®) will be given orally at a dose of 40 mg on days 1, 2, 3, 8, 15 and 22 during the first cycle and once a week on days 1, 8, 15, and 22 for each subsequent cycle. Clarithromycin (Biaxin®) will be given orally at a dose of 500 mg twice a day beginning on day 2 of cycle 1. Lenalidomide (Revlimid®) will be given orally at a dose of 25 mg daily beginning on day 3 and ending on day 21 of cycle 1 and on days 1-21 of subsequent cycles.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject must voluntarily sign and understand written informed consent.
  • Histologically confirmed Durie-Salomon stage II or III MM (see Appendix II). Stage I MM patients will be eligible if they display poor prognostic factors (ß2M \> or = 5.5 mg/L, plasma cell proliferation index \> or = 5%, albumin of less then 3.0, and unfavorable cytogenetics).
  • Measurable disease as defined by \> 1.0 g/dL serum monoclonal protein, \>0.1 g/dL serum free light chains, \> 0.2 g/24 hrs urinary M-protein excretion, and/or measurable plasmacytoma(s).
  • Age \> or = 18 years at the time of signing the informed consent form.
  • Karnofsky performance status \> or = 70% (\>60% if due to bony involvement of myeloma (see Appendix V).
  • No prior treatment or less than one full course of first-line therapy. Patients may be receiving adjuvant antiresorptive therapy (i.e., pamidronate or zoledronic acid) as routine care.
  • If the patient is a woman of childbearing age, she must have a negative serum or urine pregnancy test within 7 days of starting study.
  • Due to the unknown risk of teratogenic side effects, subjects (women and men) must agree to use effective contraception throughout the duration of the study and for at least 1 month after discontinuation of study drugs.
  • Life expectancy \> 3 months
  • Absolute neutrophil count (ANC)\> or = 1000 cells/mm3 (1.0 x 109/L)
  • Platelets count \> or = 75,000/mm3 (75 x 109/L)
  • Serum SGOT/AST \< 3.0 x upper limits of normal (ULN)
  • Serum SGPT/ALT \< 3.0 x upper limits of normal (ULN)
  • Serum creatinine \< 2.5 mg/dL (221 µmol/L)
  • Serum total bilirubin \< 2.0 mg/dL (34 µmol/L)

You may not qualify if:

  • Patients with non-secretory MM (no measurable monoclonal protein, free light chains, and/or M-spike in blood or urine).
  • Prior history of other malignancies (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless disease free for ³ 5 years.
  • NYHA Class III or IV heart disease. History of active angina, congestive heart disease, or myocardial infarction within 6 months.
  • Pregnant or lactating women are ineligible.
  • Known HIV positivity
  • Active viral or bacterial infections or any coexisting medical problem that would significantly increase the risks of this treatment program.
  • Known hypersensitivity to dexamethasone, clarithromycin, lenalidomide, or thalidomide.
  • Prior therapy for the treatment of MM
  • History of thromboembolic event or other condition currently requiring anticoagulation with warfarin (Coumadin). Patients whose therapy is changed to heparin are eligible.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weill Medical College of Cornell University

New York, New York, 10021, United States

Location

Related Publications (2)

  • Rossi A, Mark T, Jayabalan D, Christos P, Zafar F, Pekle K, Pearse R, Chen-Kiang S, Coleman M, Niesvizky R. BiRd (clarithromycin, lenalidomide, dexamethasone): an update on long-term lenalidomide therapy in previously untreated patients with multiple myeloma. Blood. 2013 Mar 14;121(11):1982-5. doi: 10.1182/blood-2012-08-448563. Epub 2013 Jan 8.

    PMID: 23299315DERIVED

  • Niesvizky R, Jayabalan DS, Christos PJ, Furst JR, Naib T, Ely S, Jalbrzikowski J, Pearse RN, Zafar F, Pekle K, Larow A, Lent R, Mark T, Cho HJ, Shore T, Tepler J, Harpel J, Schuster MW, Mathew S, Leonard JP, Mazumdar M, Chen-Kiang S, Coleman M. BiRD (Biaxin [clarithromycin]/Revlimid [lenalidomide]/dexamethasone) combination therapy results in high complete- and overall-response rates in treatment-naive symptomatic multiple myeloma. Blood. 2008 Feb 1;111(3):1101-9. doi: 10.1182/blood-2007-05-090258. Epub 2007 Nov 7.

    PMID: 17989313DERIVED

MeSH Terms

Conditions

Multiple Myeloma

Interventions

ClarithromycinLenalidomideDexamethasone

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

ErythromycinMacrolidesPolyketidesLactonesOrganic ChemicalsPhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Ruben Niesvizky, MD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 8, 2005

Study Start

December 1, 2004

Primary Completion

April 1, 2007

Study Completion

September 29, 2020

Last Updated

May 27, 2021

Record last verified: 2021-05

Locations

US(1)