Clinical trial · Interventional
Clarithromycin,Lenalidomide and Dexamethasone for Relapsed/Refractory Myeloma
Efficacy and Safety Study of BiRD (Biaxin [Clarithromycin]/Revlimid [Lenalidomide]/Dexamethasone) Combination Therapy in Relapsed/Refractory Myeloma
NCT02986451CI-TRIAL-00034338withdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This phase II study investigating the efficacy and safety of a combination of biaxin,lenalidomide and dexamethasone in subjects with relapsed/refractory MM.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Relapse/Refractory Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| clarithromycin | Drug | — | UNRESOLVED |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Lenalidomide | Drug | Lenalidomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intervention
- description
- All patients received clarithromycin, lenalidomide, and dexamethasone in 28-day cycles. Dexamethasone (40 mg) was given orally on days 1, 8, 15, and 22. Clarithromycin (500 mg) was given orally twice daily.Lenalidomide (25 mg) was given orally daily on days 1 to 21
- interventionNames
- Drug: clarithromycin
- Drug: Lenalidomide
- Drug: Dexamethasone
Primary outcomes (1)
- measure
- Overall Response Rate (ORR)
- timeFrame
- 30 months
- description
- ORR is defined as the proportion of patients with CR, nCR or partial response (PR) based on modified EBMT criteria per investigator assessment
Secondary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Patient has a previous diagnosis of multiple myeloma * Patient requires retreatment for multiple myeloma * Subject has measurable disease as defined by \> 0.5 g/dL serum monoclonal protein, \>10 mg/dL involved serum free light chain (either kappa or lambda) provided that the serum free light chain ratio is abnormal, \>0.2 g/24 hrs urinary M-protein excretion, and/or measurable plasmacytoma(s) of at least 1cm in greatest dimension as measured by either CT scanning or MRI * Subject has a Karnofsky performance status ≥60% (\>50% if due to bony involvement of myeloma (see Appendix IV) * Subject has a life expectancy ≥ 3 months * Subjects must meet the following laboratory parameters: Absolute neutrophil count (ANC) ≥750 cells/mm3 (1.0 x 109/L) Hemoglobin ≥ 7 g/dL Platelet count ≥ 75,000/mm3 (30 x 109/L if extensive bone marrow infiltration) Serum SGOT/AST \<3.0 x upper limits of normal (ULN) Serum SGPT/ALT \<3.0 x upper limits of normal (ULN) Serum total bilirubin \<2.0 mg/dL (34 µmol/L) Creatinine clearance ≥ 30 cc/min Exclusion Criteria: * Subject has immeasurable MM (no measurable monoclonal protein, free light chains in blood or urine, or measureable plasmacytoma on radiologic scanning) * Subject has a prior history of other malignancies unless disease-free for ≥ 5 years, except for basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or localized prostate cancer with Gleason score \< 7 with stable prostate specific antigen (PSA) levels * Subject has had myocardial infarction within 6 months prior to enrollment, or NYHA (New York Hospital Association) Class III or IV heart failure (see Appendix VI), Ejection Fraction \< 35%, uncontrolled angina, severe uncontrolled ventricular arrhythmias, electrocardiographic evidence of acute ischemia or active conduction system abnormalities * Female subject who is pregnant or lactating * Subject has known HIV infection * Subject has known active hepatitis B or hepatitis C infection * Subject has active viral or bacterial infections or any coexisting medical problem that would significantly increase the risks of this treatment program * Subject is unable to reliably take oral medications * Subject has known hypersensitivity to dexamethasone,cyclophosphamide,paclitaxel * Subject has a history of thromboembolic event within the past 4 weeks prior to enrollment * Subject has any clinically significant medical or psychiatric disease or condition that, in the investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent
References
Publications (0)
Data not yet available
No reference posted for this study.