DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Weill Medical College of Cornell University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Myeloma

Intervention: carfilzomib (Drug); Dexamethasone (Drug); Clarithromycin (Drug); Lenalidomide (Drug); Dexamethasone (Drug); Lenalidomide (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Weill Medical College of Cornell University

Official(s) and/or principal investigator(s):
Tomer Mark, M.D., Principal Investigator, Affiliation: Weill Cornell Medicial College

Overall contact:
Tomer Mark, M.D., Phone: (646) 962-2071, Email: tom9009@med.cornell.edu

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.

Clinical Details

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

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Response to Car-BiRD treatment.

Secondary outcome: Event free survival

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Tomer Mark, M.D., Phone: (646) 962-2071, Email: tom9009@med.cornell.edu

Weill Cornell Medicial College, New York, New York 10021, United States; Recruiting
Linda Tegnestam, R.N., Phone: 212-746-1480, Email: lit2011@med.cornell.edu
Tomer Mark, M.D., Principal Investigator
Ruben Niesvizky, M.D., Sub-Investigator
Roger Pearse, M.D., Sub-Investigator
Tsiporah Shore, M.D., Sub-Investigator
Additional Information

Starting date: March 2012
Last updated: June 17, 2013

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017