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

NCT01559935 | Active Not Recruiting Phase 2 Results DMC FDA Drug

• 1 other identifier: 1108011903
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• 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.

  From baseline to best response, up to 116 weeks.

Secondary Outcomes (4)

• 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.

• MRD Negativity Following CarBiRD Regimen

  From start of study up to Revlimid Maintenance Cycle 4.

• Progression Free Survival

  From start of study drug until first incidence of progression, up to 1222 days.

• Stem Cells Collection

  At the end of the Car Phase, prior to the start of the BiRD Phase, on average after 162 days.

Study Arms (1)

Car-BiRD Therapy

EXPERIMENTAL

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

Drug: carfilzomib; Drug: Dexamethasone; Drug: Clarithromycin; Drug: Lenalidomide

Interventions

carfilzomib DRUG

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

Car-BiRD Therapy

Dexamethasone DRUG

20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib.

Also known as: DECADRON®

Car-BiRD Therapy

Clarithromycin DRUG

500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.

Also known as: Biaxin

Car-BiRD Therapy

Lenalidomide DRUG

25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.

Also known as: Revlimid

Car-BiRD Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

carfilzomib; Dexamethasone; Calcium Dobesilate; Clarithromycin; Lenalidomide

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Erythromycin; Macrolides; Polyketides; Lactones; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Ruben Niesvizky, MD
• Organization: Weill Cornell Medicine

run9001@med.cornell.edu

6469626500

Study Officials

• Ruben Niesvizky, M.D.

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2012
• First Posted: March 21, 2012
• Study Start: April 19, 2012
• Primary Completion: June 7, 2016
• Study Completion (Estimated): March 1, 2027
• Last Updated: September 8, 2025
• Results First Posted: March 22, 2017

Record last verified: 2025-08

Locations

US (1)