GEM-CLARIDEX: Ld vs BiRd
GEM-CLARIDEX
GEM-CLARIDEX: Lenalidomide and Dexamethasone (Ld) Versus Clarithromycin / Lenalidomide [Revlimid®] / Dexamethasone (BiRd) as Initial Therapy in Multiple Myeloma
1 other identifier
interventional
286
1 country
26
Brief Summary
This phase III study, open-label, randomized study investigating lenalidomide and dexamethasone with and without biaxin in subjects with newly diagnosed, previously untreated MM. Eligible subjects will be randomized in a 1:1 ratio to receive a regimen consisting of either biaxin, lenalidomide, and low-dose dexamethasone (BiRd arm), or lenalidomide and low-dose dexamethasone (Rd arm). 306 patients will be included (50% in Spain (153) and 50% in the USA (153)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 multiple-myeloma
Started Sep 2015
Longer than P75 for phase_3 multiple-myeloma
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 12, 2015
CompletedFirst Posted
Study publicly available on registry
October 14, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2024
CompletedFebruary 1, 2022
January 1, 2022
9.1 years
October 12, 2015
January 17, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Progression free survival
Throught the study. Approximately 4 years
Study Arms (2)
BiRd
EXPERIMENTALSubjects on the BiRD arm will receive clarithromycin, Revlimid (lenalidomide), and dexamethasone in 28-day cycles. Dosing is as follows: * 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 for patients with a calculated creatinine clearance of \>60 cc/min. Patients with a calculated creatinine clearance of \<60 cc/min will receive 15 mgs PO daily on days 1-21 of a 28 cycle. * Dexamethasone 40mg PO will be given on days 1, 8, 15, 22 of a 28-day cycle.
Rd
ACTIVE COMPARATORSubjects on the Rd arm will receive Revlimid, and dexamethasone in 28-day cycles. Dosing is as follows: * Lenalidomide 25mg PO daily on days 1-21 of a 28-day cycle. If a dose of lenalidomide is missed, it should be taken as soon as possible on the same day. If it is missed for the entire day, it should not be made up. Vomited doses will not be made up.Patients with renal failure will recived an ajusted dose. * Dexamethasone 40mg PO will be given on days 1, 8, 15, 22 of a 28-day cycle. Missed or vomited doses will not be made up. If subject cannot tolerate oral dexamethasone, it will be given intravenously. In patients over 75 years old, dexametasona oral will be given at dose of 20mg on days 1, 8, 15, 22 .
Interventions
25mg PO daily on days 1-21 of a 28-day cycle for patients with a calculated creatinine clearance of \>60 cc/min
Eligibility Criteria
You may qualify if:
- Subject must voluntarily sign and understand written informed consent
- Subject is \>=65 years at the time of signing the consent form
- Subject has histologically confirmed MM 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)
- If subject is a female of childbearing potential (FCBP), ( A female of childbearing potential is a sexually mature woman who:
- has not undergone a hysterectomy or bilateral oophorectomy; or
- has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months). 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 FCBP even if they have had a successful vasectomy. See Appendix III: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods
- 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 ≥ 75,000/mm3 (30 x 109/L if extensive bone marrow infiltration)
- +3 more criteria
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 (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 MM
- Patients with symptomatic primary amiloidosis or symptomatic secondary amiloidosis (in patients with diagnosis of múltiple myeloma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- PETHEMA Foundationlead
- Cabyc, S.L.collaborator
Study Sites (26)
CHUAC
A Coruña, Spain
Hospital Universitario Germans Trias i Pujol
Badalona, Spain
Hospital Clinic
Barcelona, Spain
Hospital Universitario Vall d'Hebron
Barcelona, Spain
Hospital General de Castelló
Castelló, Spain
Hospital de Cabueñes
Gijón, Spain
Hospital Universitario Virgen de las Nieves
Granada, Spain
H. del SAS de Jerez
Jerez de la Frontera, Spain
Hospital de León
León, Spain
H. U. Gregorio Marañón
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario de la Princesa
Madrid, Spain
Hospital Costa del Sol
Marbella, Spain
Hospital Universitario Virgen de la Victoria
Málaga, Spain
Hospital General Universitario Morales Meseguer
Murcia, Spain
Complejo Hospitalario de Navarra
Pamplona, Spain
Hospital Univeristario Salamanca
Salamanca, Spain
Hospital Universitario de Canarias
Santa Cruz de Tenerife, Spain
Hospital Marqués de Valdecilla
Santander, Spain
Hospital Universitario de Santiago de Compostela
Santiago de Compostela, Spain
Hospital Universitario Virgen de Valme
Seville, Spain
Hospital Universitario Virgen del Rocío
Seville, Spain
H. Clínico de Valencia
Valencia, Spain
Hospital Universitario Dr Peset
Valencia, Spain
Hospital Universitario y Politécnico La Fe
Valencia, Spain
H. U. Txagorritxu
Vitoria-Gasteiz, Spain
Related Publications (2)
Jelinek T, Bezdekova R, Zihala D, Sevcikova T, Anilkumar Sithara A, Pospisilova L, Sevcikova S, Polackova P, Stork M, Knechtova Z, Venglar O, Kapustova V, Popkova T, Muronova L, Chyra Z, Hrdinka M, Simicek M, Garces JJ, Puig N, Cedena MT, Jurczyszyn A, Castillo JJ, Penka M, Radocha J, Mateos MV, San-Miguel JF, Paiva B, Pour L, Rihova L, Hajek R. More Than 2% of Circulating Tumor Plasma Cells Defines Plasma Cell Leukemia-Like Multiple Myeloma. J Clin Oncol. 2023 Mar 1;41(7):1383-1392. doi: 10.1200/JCO.22.01226. Epub 2022 Oct 31.
PMID: 36315921DERIVEDPuig N, Hernandez MT, Rosinol L, Gonzalez E, de Arriba F, Oriol A, Gonzalez-Calle V, Escalante F, de la Rubia J, Gironella M, Rios R, Garcia-Sanchez R, Arguinano JM, Alegre A, Martin J, Gutierrez NC, Calasanz MJ, Martin ML, Couto MDC, Casanova M, Arnao M, Perez-Persona E, Garzon S, Gonzalez MS, Martin-Sanchez G, Ocio EM, Coleman M, Encinas C, Vale AM, Teruel AI, Cortes-Rodriguez M, Paiva B, Cedena MT, San-Miguel JF, Lahuerta JJ, Blade J, Niesvizky R, Mateos MV. Lenalidomide and dexamethasone with or without clarithromycin in patients with multiple myeloma ineligible for autologous transplant: a randomized trial. Blood Cancer J. 2021 May 21;11(5):101. doi: 10.1038/s41408-021-00490-8.
PMID: 34021118DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 12, 2015
First Posted
October 14, 2015
Study Start
September 1, 2015
Primary Completion
October 1, 2024
Study Completion
October 1, 2024
Last Updated
February 1, 2022
Record last verified: 2022-01