BiRd vs. Rd as Initial Therapy in Multiple Myeloma

• Status: Active, not recruiting
• Trial end date: 2023-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Weill Medical College of Cornell University
• Collaborator: Celgene Corporation
• Treatments: BB 1101; Clarithromycin; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Lenalidomide; Thalidomide

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