---
title: Phase II Study of Biaxin, Revlimid, and Dexamethasone for Untreated Multiple Myeloma
nct_id: NCT00151203
overall_status: COMPLETED
phase: PHASE2
sponsor: Weill Medical College of Cornell University
study_type: INTERVENTIONAL
primary_condition: Multiple Myeloma
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00151203.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00151203"
ct_last_update_post_date: 2021-05-27
last_seen_at: "2026-05-12T06:16:05.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Phase II Study of Biaxin, Revlimid, and Dexamethasone for Untreated Multiple Myeloma

**Official Title:** A Phase II Study of Clarithromycin (Biaxin), Lenalidomide (Revlimid), and Dexamethasone (Decadron) for Newly Diagnosed Subjects With Multiple Myeloma

**NCT ID:** [NCT00151203](https://clinicaltrials.gov/study/NCT00151203)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 50
- **Lead Sponsor:** Weill Medical College of Cornell University
- **Collaborators:** Celgene Corporation
- **Conditions:** Multiple Myeloma
- **Start Date:** 2004-12
- **Completion Date:** 2020-09-29
- **CT.gov Last Update:** 2021-05-27

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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.
```

## Interventions

- **Clarithromycin, Lenalidomide, Dexamethasone** (DRUG) — 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.

## Primary Outcomes

- **Response rate, time to maximum response, toxicities** _(time frame: 3 years)_

## Locations (1)

- Weill Medical College of Cornell University, New York, New York, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.weill medical college of cornell university|new york|new york|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00151203.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00151203*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*