Multiple MyelomaPhase 2CarBiRDNCT01559935
Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) [Car-BiRD] Therapy for Subjects With Multiple Myeloma
A Phase 2 study testing carfilzomib, Dexamethasone and Clarithromycin in people with Multiple Myeloma, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of an investigational new drug called carfilzomib, in combination with dexamethasone in subjects with newly diagnosed multiple myeloma followed by treatment with a combination of drugs clarithromycin (Biaxin®), lenalidomide (Revlimid®) and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- carfilzomib, Dexamethasone and Clarithromycin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Apr 2012to 19 Mar 2026
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must voluntarily sign and understand written informed consent.
- Subject is ≥ 18 years at the time of signing the consent form.
- Subject has histologically confirmed multiple myeloma that has never before been treated.
- Subject had no anti-myeloma 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 VI).
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- 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 (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with females of child bearing potential even if they have had a successful vasectomy.
- 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 creatinine < 2.5 mg/dL (221 µmol/L)
- Serum total bilirubin < 2.0 mg/dL (34 µmol/L)
Who cannot join
- 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, 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.
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- Subject has active viral or bacterial infections or any coexisting medical problem that would significantly increase the risks of this treatment program.
- Subject has known hypersensitivity to dexamethasone, clarithromycin, lenalidomide, thalidomide, allopurinol, or carfilzomib.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medical College
New York, New York, 10021
About this study
Official title: A Phase II Study of Sequential Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) [Car-BiRD] Therapy for Subjects With Newly Diagnosed Multiple Myeloma
The purpose of this study is to evaluate the safety and effectiveness of an investigational new drug called carfilzomib, in combination with dexamethasone in subjects with newly diagnosed multiple myeloma followed by treatment with a combination of drugs clarithromycin (Biaxin®), lenalidomide (Revlimid®) and dexamethasone (Decadron®) [BiRD] then lenalidomide alone.
Read the detailed description
While new anti-myeloma therapies such as bortezomib and immunomodulatory drugs have been developed, multiple myeloma remains an incurable malignancy. Given that obtaining a complete remission (CR) with therapy will allow patients with newly diagnosed multiple myeloma to enjoy a higher quality of life and longer duration of freedom from disease symptoms, finding an optimally effective and well-tolerated regimen is imperative.
The robust overall response rate of 91% with the BiRD regimen for patients with newly diagnosed multiple myeloma is encouraging and we believe that by adding carfilzomib the overall response rate and CR rate can be improved. As carfilzomib has proven efficacy in myeloma and in patient's who have relapsed on bortezomib, we anticipate that it will synergize with the previous BiRD regimen to induce greater reduction of tumor burden overall.
The primary endpoints include best response rate, toxicities, progression free survival, event free survival, and overall survival. In those patients who are eligible for autologous stem cell transplantation, we will also study the effect of carfilzomib on CD 34+ stem cell yield following mobilization.
- Conditions
- Multiple Myeloma
- Being tested
- carfilzomib, Dexamethasone, Clarithromycin, Lenalidomide
- Keywords
- Multiple Myeloma
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carfilzomibDrug
45 mg/m2 IV on days 1, 2, 8, 9, 15 and 16 of each 28 day cycles.
DexamethasoneDrug
Also called DECADRON®
20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib.
ClarithromycinDrug
Also called Biaxin
500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.
LenalidomideDrug
Also called Revlimid
25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.
DexamethasoneDrug
40 mg orally on days 1, 8, 15 and 22 of each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.
LenalidomideDrug
Also called Revlimid
10 mg orally on days 1-21 or each 28 day cycle of maintenance. Maintenance begins after BiRD treatment has been completed.
| Study group | Role | What they receive |
|---|---|---|
| Car-BiRD Therapy | Experimental | Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) [Car-BiRD] Receives: Drug: carfilzomib; Drug: Dexamethasone; Drug: Clarithromycin; Drug: Lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to Car-BiRD Treatment.
The best response for all patients who had at least one dose of drug was measured.
Response categories:
Stringent Complete Response (sCR), Complete Remission(CR), Very Good Partial Remission(VGPR), Partial Remission (PR), Progressive Disease (PD), Stable Disease (SD).
The response is evaluated based on the IMWG criteria.
Measured: From baseline to best response, up to 116 weeks.
Secondary outcomes (4)
Event Free Survival
an event is defined by coming off protocol for any reason, including progression of disease, lack of disease response, regimen intolerability, withdrawal of consent or death.
Measured: From date of study enrollment until the date of removal of study due to progression of disease, toxicity or withdrawal of consent, up to 1222 days.
MRD Negativity Following CarBiRD Regimen
Minimal Residual Disease (MRD) was assessed for all participants as soon as they achieved CR/sCR, regardless of what phase they were on.
MRD negativity is defined as the complete absence of plasma cells on bone marrow biopsy.
MRD positivity is defined as the presence of residual plasma cells (<5%) on bone marrow biopsy.
The IMWG criteria were used to determine CR and sCR.
Measured: From start of study up to Revlimid Maintenance Cycle 4.
Progression Free Survival
Progression was defined using the IMWG criteria.
Measured: From start of study drug until first incidence of progression, up to 1222 days.
Stem Cells Collection
At the end of the Car Phase, all participants underwent stem cell collection.
Measured: At the end of the Car Phase, prior to the start of the BiRD Phase, on average after 162 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2012 (estimated)
- Study start19 Apr 2012
- Primary completion7 Jun 2016
- Study completion19 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Onyx Therapeutics, Inc.
- Responsible party
- Sponsor
- Investigators
- Ruben Niesvizky, M.D., Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01559935
- Sponsor's protocol ID
- 1108011903
- Acronym
- CarBiRD
- Status last verified
- Sep 2026
- First submitted
- 16 Feb 2012
- Last updated
- 29 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No