CarBiRD: Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) [Car-BiRD] Therapy for Subjects With Multiple Myeloma

Sponsor
Weill Medical College of Cornell University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT01559935
Collaborator
Onyx Therapeutics, Inc. (Industry)
74
Enrollment
1
Location
1
Arm
120
Anticipated Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief 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 dexamethasone (Decadron®) [BiRD] then lenalidomide alone.

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
74 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Mar 1, 2012
Actual Primary Completion Date :
Jun 7, 2016
Anticipated Study Completion Date :
Mar 1, 2022

Arms and Interventions

ArmIntervention/Treatment
Experimental: Car-BiRD Therapy

Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) [Car-BiRD]

Drug: carfilzomib
45 mg/m2 IV on days 1, 2, 8, 9, 15 and 16 of each 28 day cycles.

Drug: Dexamethasone
20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib.
Other Names:
  • DECADRON®
  • Drug: Clarithromycin
    500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.
    Other Names:
  • Biaxin
  • Drug: Lenalidomide
    25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.
    Other Names:
  • Revlimid
  • Drug: Dexamethasone
    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.

    Drug: Lenalidomide
    10 mg orally on days 1-21 or each 28 day cycle of maintenance. Maintenance begins after BiRD treatment has been completed.
    Other Names:
  • Revlimid
  • Outcome Measures

    Primary Outcome Measures

    1. Response to Car-BiRD Treatment. [From baseline to best response, up to 116 weeks.]

      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.

    Secondary Outcome Measures

    1. Event Free Survival [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.]

      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.

    2. MRD Negativity Following CarBiRD Regimen [From start of study up to Revlimid Maintenance Cycle 4.]

      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.

    3. Progression Free Survival [From start of study drug until first incidence of progression, up to 1222 days.]

      Progression was defined using the IMWG criteria.

    4. Stem Cells Collection [At the end of the Car Phase, prior to the start of the BiRD Phase, on average after 162 days.]

      At the end of the Car Phase, all participants underwent stem cell collection.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • 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).

    • 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)

    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, 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 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.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Weill Cornell Medical CollegeNew YorkNew YorkUnited States10021

    Sponsors and Collaborators

    • Weill Medical College of Cornell University
    • Onyx Therapeutics, Inc.

    Investigators

    • Principal Investigator: Adriana Rossi, M.D., Weill Medical College of Cornell University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Weill Medical College of Cornell University
    ClinicalTrials.gov Identifier:
    NCT01559935
    Other Study ID Numbers:
    • 1108011903
    First Posted:
    Mar 21, 2012
    Last Update Posted:
    May 17, 2021
    Last Verified:
    May 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Weill Medical College of Cornell University
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment DetailTwo subjects were ineligible and therefore never started treatment.
    Arm/Group TitleCar-BiRD Therapy
    Arm/Group DescriptionCarfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) [Car-BiRD] Car Phase: carfilzomib: 45 mg/m2 IV on days 1, 2, 8, 9, 15 and 16 of each 28 day cycles. Dexamethasone: 20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib. BiRD Phase: Clarithromycin: 500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed. Lenalidomide: 25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed. Dexamethasone: 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. Maintenance Phase: Lenalidomide: 10 mg orally on days 1-21 or each 28 day cycle of maintenance. Maintenance begins after BiRD treatment has been completed.
    Period Title: Car Phase
    STARTED72
    COMPLETED58
    NOT COMPLETED14
    Period Title: Car Phase
    STARTED58
    COMPLETED54
    NOT COMPLETED4
    Period Title: Car Phase
    STARTED54
    COMPLETED0
    NOT COMPLETED54

    Baseline Characteristics

    Arm/Group TitleCar-BiRD Therapy
    Arm/Group DescriptionCarfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) [Car-BiRD] Car Phase: carfilzomib: 45 mg/m2 IV on days 1, 2, 8, 9, 15 and 16 of each 28 day cycles. Dexamethasone: 20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib. BiRD Phase: Clarithromycin: 500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed. Lenalidomide: 25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed. Dexamethasone: 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. Maintenance Phase: Lenalidomide: 10 mg orally on days 1-21 or each 28 day cycle of maintenance. Maintenance begins after BiRD treatment has been completed.
    Overall Participants72
    Age, Customized (years) [Mean (Full Range) ]
    Car Phase
    60.4
    BiRD Phase
    59.6
    Maintenance Phase
    59.2
    Sex: Female, Male (Count of Participants)
    Female
    29
    40.3%
    Male
    43
    59.7%
    Female
    26
    36.1%
    Male
    32
    44.4%
    Female
    23
    31.9%
    Male
    31
    43.1%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    3
    4.2%
    Not Hispanic or Latino
    61
    84.7%
    Unknown or Not Reported
    8
    11.1%
    Hispanic or Latino
    3
    4.2%
    Not Hispanic or Latino
    48
    66.7%
    Unknown or Not Reported
    7
    9.7%
    Hispanic or Latino
    2
    2.8%
    Not Hispanic or Latino
    45
    62.5%
    Unknown or Not Reported
    7
    9.7%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    Asian
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    Black or African American
    5
    6.9%
    White
    29
    40.3%
    More than one race
    6
    8.3%
    Unknown or Not Reported
    32
    44.4%
    American Indian or Alaska Native
    0
    0%
    Asian
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    Black or African American
    4
    5.6%
    White
    22
    30.6%
    More than one race
    5
    6.9%
    Unknown or Not Reported
    27
    37.5%
    American Indian or Alaska Native
    0
    0%
    Asian
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    Black or African American
    3
    4.2%
    White
    20
    27.8%
    More than one race
    5
    6.9%
    Unknown or Not Reported
    26
    36.1%

    Outcome Measures

    1. Primary Outcome
    TitleResponse to Car-BiRD Treatment.
    DescriptionThe 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.
    Time FrameFrom baseline to best response, up to 116 weeks.

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleCar-BiRD Therapy
    Arm/Group DescriptionCarfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) [Car-BiRD] Car Phase: carfilzomib: 45 mg/m2 IV on days 1, 2, 8, 9, 15 and 16 of each 28 day cycles. Dexamethasone: 20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib. BiRD Phase: Clarithromycin: 500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed. Lenalidomide: 25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed. Dexamethasone: 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. Maintenance Phase: Lenalidomide: 10 mg orally on days 1-21 or each 28 day cycle of maintenance. Maintenance begins after BiRD treatment has been completed.
    Measure Participants72
    sCR/CR
    28
    38.9%
    VGPR
    31
    43.1%
    PR
    11
    15.3%
    SD
    1
    1.4%
    PD
    0
    0%
    Not Evaluable
    1
    1.4%
    2. Secondary Outcome
    TitleEvent Free Survival
    Descriptionan 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.
    Time FrameFrom 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.

    Outcome Measure Data

    Analysis Population Description
    44 participants analyzed out of the 72 participants initially enrolled in the study. 28 participants are active and therefore have not experienced any events leading to removal from study.
    Arm/Group TitleCar-BiRD Therapy
    Arm/Group DescriptionCarfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) [Car-BiRD] Car Phase: carfilzomib: 45 mg/m2 IV on days 1, 2, 8, 9, 15 and 16 of each 28 day cycles. Dexamethasone: 20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib. BiRD Phase: Clarithromycin: 500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed. Lenalidomide: 25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed. Dexamethasone: 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. Maintenance Phase: Lenalidomide: 10 mg orally on days 1-21 or each 28 day cycle of maintenance. Maintenance begins after BiRD treatment has been completed.
    Measure Participants44
    Median (Full Range) [Days]
    401.5
    3. Secondary Outcome
    TitleMRD Negativity Following CarBiRD Regimen
    DescriptionMinimal 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.
    Time FrameFrom start of study up to Revlimid Maintenance Cycle 4.

    Outcome Measure Data

    Analysis Population Description
    28 participants achieved CR or sCR.
    Arm/Group TitleCar-BiRD Therapy
    Arm/Group DescriptionCarfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) [Car-BiRD] Car Phase: carfilzomib: 45 mg/m2 IV on days 1, 2, 8, 9, 15 and 16 of each 28 day cycles. Dexamethasone: 20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib. BiRD Phase: Clarithromycin: 500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed. Lenalidomide: 25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed. Dexamethasone: 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. Maintenance Phase: Lenalidomide: 10 mg orally on days 1-21 or each 28 day cycle of maintenance. Maintenance begins after BiRD treatment has been completed.
    Measure Participants28
    MRD positive
    10
    13.9%
    MRD negative
    17
    23.6%
    Not Evaluable
    1
    1.4%
    4. Secondary Outcome
    TitleProgression Free Survival
    DescriptionProgression was defined using the IMWG criteria.
    Time FrameFrom start of study drug until first incidence of progression, up to 1222 days.

    Outcome Measure Data

    Analysis Population Description
    21 participants had an incidence of progression.
    Arm/Group TitleCar-BiRD Therapy
    Arm/Group DescriptionCarfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) [Car-BiRD] Car Phase: carfilzomib: 45 mg/m2 IV on days 1, 2, 8, 9, 15 and 16 of each 28 day cycles. Dexamethasone: 20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib. BiRD Phase: Clarithromycin: 500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed. Lenalidomide: 25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed. Dexamethasone: 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. Maintenance Phase: Lenalidomide: 10 mg orally on days 1-21 or each 28 day cycle of maintenance. Maintenance begins after BiRD treatment has been completed.
    Measure Participants21
    Median (Full Range) [months]
    18.3
    5. Secondary Outcome
    TitleStem Cells Collection
    DescriptionAt the end of the Car Phase, all participants underwent stem cell collection.
    Time FrameAt the end of the Car Phase, prior to the start of the BiRD Phase, on average after 162 days.

    Outcome Measure Data

    Analysis Population Description
    58 participants reached the end of the Car Phase. From those 58 participants, 52 were collected, 5 participants declined stem cell collection and 1 participant's results were not evaluable.
    Arm/Group TitleCar-BiRD Therapy
    Arm/Group DescriptionCarfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) [Car-BiRD] Car Phase: carfilzomib: 45 mg/m2 IV on days 1, 2, 8, 9, 15 and 16 of each 28 day cycles. Dexamethasone: 20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib. BiRD Phase: Clarithromycin: 500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed. Lenalidomide: 25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed. Dexamethasone: 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. Maintenance Phase: Lenalidomide: 10 mg orally on days 1-21 or each 28 day cycle of maintenance. Maintenance begins after BiRD treatment has been completed.
    Measure Participants52
    Mean (Standard Deviation) [Number of stem cells collected per Kg]
    12854635
    (5388946.9)

    Adverse Events

    Time Frame
    Adverse Event Reporting Description Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
    Arm/Group TitleCar-BiRD Therapy
    Arm/Group DescriptionCarfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) [Car-BiRD] Car Phase: carfilzomib: 45 mg/m2 IV on days 1, 2, 8, 9, 15 and 16 of each 28 day cycles. Dexamethasone: 20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib. BiRD Phase: Clarithromycin: 500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed. Lenalidomide: 25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed. Dexamethasone: 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. Maintenance Phase: Lenalidomide: 10 mg orally on days 1-21 or each 28 day cycle of maintenance. Maintenance begins after BiRD treatment has been completed.
    All Cause Mortality
    Car-BiRD Therapy
    Affected / at Risk (%)# Events
    Total1/72 (1.4%)
    Serious Adverse Events
    Car-BiRD Therapy
    Affected / at Risk (%)# Events
    Total26/72 (36.1%)
    Cardiac disorders
    atrial fibrilation1/72 (1.4%) 1
    massive heart attack1/72 (1.4%) 1
    acute coronary syndrome1/58 (1.7%) 1
    cardiac chest pain1/54 (1.9%) 1
    Gastrointestinal disorders
    diarrhea1/54 (1.9%) 2
    Infections and infestations
    abnominal infection1/72 (1.4%) 2
    lung infection3/72 (4.2%) 4
    URI2/72 (2.8%) 2
    UTI2/72 (2.8%) 2
    lung infection3/58 (5.2%) 3
    lung infection4/54 (7.4%) 4
    acute kidney infection1/54 (1.9%) 1
    enterocolitis infection1/54 (1.9%) 1
    Injury, poisoning and procedural complications
    fall1/72 (1.4%) 1
    Metabolism and nutrition disorders
    increased creatinine1/72 (1.4%) 1
    dehydration1/72 (1.4%) 1
    creatinine increase1/54 (1.9%) 1
    Musculoskeletal and connective tissue disorders
    femur fracture1/72 (1.4%) 1
    spinal fracture1/72 (1.4%) 1
    back pain1/72 (1.4%) 1
    non-cardiac chest pain1/58 (1.7%) 1
    abdominal pain (small intestinal obstruction)1/58 (1.7%) 1
    non-cardiac chest pain3/54 (5.6%) 3
    spinal cord compression1/54 (1.9%) 1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    thyroid cancer1/72 (1.4%) 1
    secondary malignancy1/54 (1.9%) 1
    Nervous system disorders
    syncope1/72 (1.4%) 1
    confusion1/72 (1.4%) 1
    Respiratory, thoracic and mediastinal disorders
    dyspnea2/72 (2.8%) 2
    pulmonary embolism1/72 (1.4%) 1
    Surgical and medical procedures
    surgical procedure1/72 (1.4%) 1
    Vascular disorders
    fever2/72 (2.8%) 3
    thromboembolic event1/54 (1.9%) 1
    Other (Not Including Serious) Adverse Events
    Car-BiRD Therapy
    Affected / at Risk (%)# Events
    Total72/72 (100%)
    Blood and lymphatic system disorders
    anemia52/72 (72.2%)
    thrombocytopenia64/72 (88.9%)
    neutropenia13/72 (18.1%)
    leukopenia25/72 (34.7%)
    lymphopenia69/72 (95.8%)
    neutropenia6/58 (10.3%)
    leukopenia5/58 (8.6%)
    lymphopenia5/58 (8.6%)
    thrombocytopenia3/54 (5.6%)
    neutropenia18/54 (33.3%)
    leukopenia11/54 (20.4%)
    Cardiac disorders
    high BNP10/72 (13.9%)
    bradycardia5/54 (9.3%)
    Eye disorders
    blurry vision5/54 (9.3%)
    Gastrointestinal disorders
    dyspepsia13/72 (18.1%)
    constipation18/72 (25%)
    nausea17/72 (23.6%)
    anorexia6/72 (8.3%)
    diarhhea25/72 (34.7%)
    vomiting8/72 (11.1%)
    flatulance7/72 (9.7%)
    dyspepsia4/58 (6.9%)
    constipation15/58 (25.9%)
    nausea7/58 (12.1%)
    anorexia4/58 (6.9%)
    diarhhea4/58 (6.9%)
    vomiting3/58 (5.2%)
    dry mouth4/58 (6.9%)
    flatulance3/58 (5.2%)
    dyspepsia13/54 (24.1%)
    constipation5/54 (9.3%)
    nausea4/54 (7.4%)
    diarhhea20/54 (37%)
    vomiting7/54 (13%)
    dry mouth3/54 (5.6%)
    flatulance3/54 (5.6%)
    General disorders
    insomnia27/72 (37.5%)
    fatigue22/72 (30.6%)
    chills4/72 (5.6%)
    insomnia5/58 (8.6%)
    malaise3/58 (5.2%)
    fatigue9/58 (15.5%)
    fatigue5/54 (9.3%)
    gait disturbance4/54 (7.4%)
    hair loss4/54 (7.4%)
    Infections and infestations
    URI12/72 (16.7%)
    UTI5/72 (6.9%)
    Skin Infection4/72 (5.6%)
    URI22/54 (40.7%)
    skin Infection4/54 (7.4%)
    ear infection3/54 (5.6%)
    Injury, poisoning and procedural complications
    fall4/54 (7.4%)
    Metabolism and nutrition disorders
    hypocalcemia56/72 (77.8%)
    hyponatremia42/72 (58.3%)
    hypoglycemia21/72 (29.2%)
    hyperglycemia63/72 (87.5%)
    hypophosphatemia35/72 (48.6%)
    hyperkalemia20/72 (27.8%)
    hypokalemia4/72 (5.6%)
    hypomagnesemia14/72 (19.4%)
    hypermagnesemia10/72 (13.9%)
    hypoalbuminemia39/72 (54.2%)
    hyperbilirubinemia23/72 (31.9%)
    hyperuricemia5/72 (6.9%)
    hyperhidrosis8/72 (11.1%)
    elevated ALT26/72 (36.1%)
    elevated AST30/72 (41.7%)
    elevated alkaline phosphatase34/72 (47.2%)
    increased creatinine35/72 (48.6%)
    hypocalcemia6/58 (10.3%)
    hypoglycemia14/58 (24.1%)
    hypokalemia4/58 (6.9%)
    hypomagnesemia7/58 (12.1%)
    elevated ALT3/58 (5.2%)
    ALK increase6/58 (10.3%)
    increased creatinine4/58 (6.9%)
    hypocalcemia7/54 (13%)
    hypercalcemia3/54 (5.6%)
    hypoglycemia7/54 (13%)
    hypophosphatemia5/54 (9.3%)
    hypokalemia4/54 (7.4%)
    hypomagnesemia13/54 (24.1%)
    hypoalbuminemia8/54 (14.8%)
    hyperbilirubinemia5/54 (9.3%)
    hyponatremia3/54 (5.6%)
    hypernatremia5/54 (9.3%)
    elevated ALT5/54 (9.3%)
    elevated AST4/54 (7.4%)
    increased creatinine7/54 (13%)
    Musculoskeletal and connective tissue disorders
    muscle spasms/cramps13/72 (18.1%)
    muscle weakness6/72 (8.3%)
    pain in legs8/72 (11.1%)
    hip pain7/72 (9.7%)
    back pain17/72 (23.6%)
    knee pain4/72 (5.6%)
    lower extremity pain4/72 (5.6%)
    muscle spasms/cramps6/58 (10.3%)
    hip pain3/58 (5.2%)
    bone pain3/58 (5.2%)
    muscle spasms/cramps5/54 (9.3%)
    shoulder pain5/54 (9.3%)
    rib pain6/54 (11.1%)
    chest pain (muscular)4/54 (7.4%)
    pain in legs5/54 (9.3%)
    hip pain10/54 (18.5%)
    back pain8/54 (14.8%)
    arthralgias11/54 (20.4%)
    neck pain3/54 (5.6%)
    pain in foot3/54 (5.6%)
    lower extremity pain6/54 (11.1%)
    upper extremity pain6/54 (11.1%)
    knee pain3/54 (5.6%)
    Nervous system disorders
    peripheral neuropathy12/72 (16.7%)
    tremor10/72 (13.9%)
    anxiety/stress13/72 (18.1%)
    dizziness / lightheaded9/72 (12.5%)
    paresthesias4/72 (5.6%)
    forgetful4/72 (5.6%)
    dysgeusia4/72 (5.6%)
    headache12/72 (16.7%)
    irritability5/72 (6.9%)
    agitation4/72 (5.6%)
    concentration impairment7/72 (9.7%)
    peripheral neuropathy3/58 (5.2%)
    tremor11/58 (19%)
    dizziness / lightheaded5/58 (8.6%)
    parethesias4/58 (6.9%)
    dysgeusia17/58 (29.3%)
    irritability7/58 (12.1%)
    peripheral neuropathy7/54 (13%)
    dizziness / lightheaded5/54 (9.3%)
    headache3/54 (5.6%)
    Psychiatric disorders
    depression6/72 (8.3%)
    anxiety/stress3/54 (5.6%)
    depression5/54 (9.3%)
    Renal and urinary disorders
    low eGFR37/72 (51.4%)
    genitourinary frequency4/72 (5.6%)
    low eGFR4/58 (6.9%)
    genitourinary frequency3/54 (5.6%)
    Respiratory, thoracic and mediastinal disorders
    Dyspnea11/72 (15.3%)
    cough12/72 (16.7%)
    sinus congestion10/72 (13.9%)
    sore throat4/72 (5.6%)
    dyspnea3/58 (5.2%)
    lung infection3/58 (5.2%)
    cough3/58 (5.2%)
    sinus congestion3/58 (5.2%)
    lung infection3/54 (5.6%)
    cough13/54 (24.1%)
    sore throat3/54 (5.6%)
    sinus congestion9/54 (16.7%)
    allergic rhinitis7/54 (13%)
    Skin and subcutaneous tissue disorders
    rash7/72 (9.7%)
    rash13/58 (22.4%)
    pruritus3/58 (5.2%)
    rash10/54 (18.5%)
    skin darknening5/54 (9.3%)
    pruritus4/54 (7.4%)
    dry skin7/54 (13%)
    Vascular disorders
    edema14/72 (19.4%)
    hypertension4/72 (5.6%)
    fever14/72 (19.4%)
    edema10/58 (17.2%)
    cushingoid appearance3/58 (5.2%)
    edema14/54 (25.9%)
    hypertension5/54 (9.3%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/TitleJennifer Hess
    OrganizationWeill Cornell Medicine
    Phone6469629440
    Emailjmh2004@med.cornell.edu
    Responsible Party:
    Weill Medical College of Cornell University
    ClinicalTrials.gov Identifier:
    NCT01559935
    Other Study ID Numbers:
    • 1108011903
    First Posted:
    Mar 21, 2012
    Last Update Posted:
    May 17, 2021
    Last Verified:
    May 1, 2021