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BiRd vs. Rd as Initial Therapy in 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: Clarithromycin (Drug); Lenalidomide (Drug); Dexamethasone (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Weill Medical College of Cornell University

Official(s) and/or principal investigator(s):
Tomer Mark, MD, Principal Investigator, Affiliation: Weill Medical College of Cornell University

Summary

This is a randomized, open-label, phase III study to investigate the efficacy of combination therapy with an induction phase utilizing a combination clarithromycin (Biaxin®), lenalidomide (Revlimid®), dexamethasone (Decadron®), in multiple myeloma patients who are newly diagnosed and require treatment when compared to patients who receive lenalidomide and dexamethasone alone.

Clinical Details

Official title: Lenalidomide and Dexamethasone (Rd) Versus Clarithromycin [Biaxin®] / Lenalidomide [Revlimid®] / Dexamethasone (BiRd) as Initial Therapy in Multiple Myeloma

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Survival duration without disease progression

Secondary outcome:

Number of subjects who demonstrate a response to BiRd treatment regimen

Number of adverse events experienced

Overall Survival

Number of months after initiating treatment with BiRd regimen to disease progression, as compared to subjects on Rd treatment regimen.

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.

Eligibility

Minimum age: 65 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Weill Cornell Medical College, New York, New York 10065, United States
Additional Information

Starting date: August 2015
Last updated: August 5, 2015

Page last updated: August 23, 2015

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