- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02516696
BiRd vs. Rd as Initial Therapy in Multiple Myeloma (BiRd vs Rd)
Lenalidomide and Dexamethasone (Rd) Versus Clarithromycin [Biaxin®] / Lenalidomide [Revlimid®] / Dexamethasone (BiRd) as Initial Therapy in Multiple Myeloma
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This research study is for men and women with newly diagnosed, previously untreated multiple myeloma. The purpose of this study is to observe the how well the different combinations of study drugs work as therapy for patients with newly diagnosed, transplant ineligible, previously untreated multiple myeloma.
The study will be done in two arms:
BiRd Arm:
- Clarithromycin 500mg PO twice daily on days 1-28 for a 28-day cycle
- Lenalidomide 25mg PO daily on days 1-21 of a 28-day cycle
- Dexamethasone 40mg PO will be given on days 1, 8, 15, 22 of a 28-day cycle
Rd Arm:
- Lenalidomide 25mg PO daily on days 1-21 of a 28-day cycle
- Dexamethasone 40mg PO will be given on days 1, 8, 15, 22 of a 28-day cycle
Subjects will be treated in 28-day cycles and may continue treatment as long as they are responding to therapy and not experiencing unacceptable side effects or disease progression. There will be an evaluation at the end of each cycle. Participants will be in the study until disease progression or unacceptable toxicity.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Colorado
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Aurora, Colorado, United States, 80045
- University of Colorado - Anschutz Cancer Center
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New York
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New York, New York, United States, 10065
- Weill Cornell Medical College
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Subject must voluntarily sign and understand written informed consent.
- Subject is at least 65 years old at the time of signing the consent form.
- Subject has histologically confirmed multiple myeloma that has never before been treated
- Subject has no prior anti-myeloma treatment therapy within 14 days prior to initiation of study treatment except for corticosteroids with a maximum allowed dosage equivalent to three pulses of dexamethasone (40mg daily for 4 days equals one pulse). Patients may have received prior adjuvant antiresorptive therapy (i.e., pamidronate or zoledronic acid) as routine care, or radiation therapy as palliation for pain and/or spinal cord compression.
- 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 is able to take prophylactic anticoagulation as detailed in section 9.1 (patients intolerant to aspirin may use warfarin or low molecular weight heparin).
- Subject is registered into the mandatory RevAssist® program, and is willing and able to comply with the requirements of RevAssist® program.
- If subject is a female of childbearing potential (FCBP),† she must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10 - 14 days prior to and again within 24 hours of prescribing lenalidomide
- 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 ≥ 30,000/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 total bilirubin <2.0 mg/dL (34 µmol/L)
- Creatinine clearance ≥ 45 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, clarithromycin, lenalidomide, or thalidomide
- 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.
- Subject has previously been treated for multiple myeloma
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BiRD treatment regimen
Subjects on the BiRD arm will receive clarithromycin, lenalidomide, and dexamethasone in 28-day cycles.
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500mg PO twice daily on days 1-28 for a 28-day cycle.
Other Names:
25 mg PO days 1-21 followed by a 7 day rest period for each 28-day cycle
Other Names:
20 mg PO on Days 1, 8, 15, and 22 for each cycle for subjects 75 years and younger.
Other Names:
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Active Comparator: Rd treatment regimen
Subjects on the Rd arm will receive lenalidomide and dexamethasone in 28-day cycles.
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25 mg PO days 1-21 followed by a 7 day rest period for each 28-day cycle
Other Names:
20 mg PO on Days 1, 8, 15, and 22 for each cycle for subjects 75 years and younger.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Survival Duration Without Disease Progression
Time Frame: Until disease progression or death from any cause, for a maximum of approximately 5 years
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Calculate rate of progression-free survival for subjects following treatment BiRd regimen compared to Rd treatment regimen.
Progression is determined by the International Myeloma Working Group Criteria.
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Until disease progression or death from any cause, for a maximum of approximately 5 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival
Time Frame: 4 years
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Survival following treatment to the date of death of subjects on BiRd regimen as compared to Rd.
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4 years
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Overall Response Rate
Time Frame: 2 years
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Capture the number of subjects who demonstrate a complete or partial response to treatment with BiRD regimen, as compared to Rd. Complete and partial responses are defined by the International Myeloma Working Group Criteria.
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2 years
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Number of Adverse Events Experienced
Time Frame: 2 years
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Capture the number of adverse events experienced with BiRd regimen as compared to Rd regimen
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2 years
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Number of Days After Initiating Treatment With BiRd Regimen to Disease Progression, as Compared to Subjects on Rd Treatment Regimen.
Time Frame: Until disease progression for a maximum of approximately 5 years
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Progression is determined by the International Myeloma Working Group Criteria.
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Until disease progression for a maximum of approximately 5 years
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Number of Patients With Objective Response Rate (CR+PR)
Time Frame: up to 3 years
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up to 3 years
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Number of Patients With Complete Response Rate (CR)
Time Frame: up to 3 years
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Complete response is defined by the International Myeloma Working Group Criteria.
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up to 3 years
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Number of Days for Event-Free Survival
Time Frame: approximately 5 years
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Descriptively presented for each treatment group and no formal statistical comparison will be made between treatment arms
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approximately 5 years
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Number of Days for Duration of Response
Time Frame: up to 3 years
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Descriptively presented for each treatment group and no formal statistical comparison will be made between treatment arms
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up to 3 years
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Number of Months to Progression-Free Survival 2
Time Frame: approximately 5 years
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Time from study entry until 2nd instance of disease progression.
Progression is determined by the International Myeloma Working Group Criteria.
Descriptively presented for each treatment group and no formal statistical comparison will be made between treatment arms.
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approximately 5 years
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Functional Assessment of Chronic Illness Therapy - Fatigue Subscale (FS; Version 4) Score of Patients Receiving BiRd vs Rd Treatment
Time Frame: up to 3 years
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The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) is a 40-item measure that assesses self-reported fatigue and its impact upon daily activities and function.
The FACIT- Fatigue Subscore (FS) is comprised of 13 items, within the total 40-item FACIT-F, that assess fatigue and its impact.
This analysis is only based on the FS score.
Items are scored on a 5 point Likert-type scale.
Item scores can range from 0 ("not at all") to 4 ("very much"), and the total, summed score from 0 to 52; lower scores indicate greater fatigue.
The recall period for each item is the past 7 days.
Data is descriptively presented for each treatment group and no formal statistical comparison will be made between treatment arms.
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up to 3 years
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jorge Monge, MD, Weill Medical College of Cornell University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Immunologic Factors
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Anti-Bacterial Agents
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- Protein Synthesis Inhibitors
- Dexamethasone
- Lenalidomide
- Clarithromycin
Other Study ID Numbers
- 1411015662
- RV-CL-MM-PI-004078 (Other Grant/Funding Number: Celgene Corporation)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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