Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

GEM-CLARIDEX: Ld vs BiRd (GEM-CLARIDEX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02575144
Recruitment Status : Recruiting
First Posted : October 14, 2015
Last Update Posted : May 14, 2019
Sponsor:
Collaborator:
Cabyc, S.L.
Information provided by (Responsible Party):
PETHEMA Foundation

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)

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Clarithromycin Drug: Lenalidomide Drug: Dexamethasone Phase 3

Detailed Description:

BiRd Arm

Subjects 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. If a dose of clarithromycin 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.
  • 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. 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.
  • 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.

Rd Arm

Subjects 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 for patients with a calculated creatinine clearance of >60 cc/min. Patients with a calculated clearance of <60 cc/min will receive 15 mgs PO daily on days 1-21 of a28 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.
  • 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.

Correlative studies: Relative dose intensity: Projected total dose per cycle of each component of assigned drug will be divided by the actual dose received and a ratio will be assessed for each cycle delivered.

MRD: Minimal residual disease testing will be performed in subjects who achieve complete response. MRD testing may be performed either by flow cytometry or polymerase chain reaction (PCR), whichever is more readily available at the study institution.

Subjects will continue their randomized treatment assignment until disease progression or unacceptable toxicity (whichever occurs first). In case toxicity precludes dosing of one agent (i.e dexamethasone, clarithromycin, lenalidomide), treatment regimen will continue with the remaining agents. Subjects unable to receive ALL the components of the assigned treatment arms will be removed from study after reasonable attempts to dose reduce and manage side effects. Subjects can also be removed from study at investigator's discretion, or if they withdraw consent. At completion or early discontinuation of treatment, subjects will be followed for 30 additional days or up to the initiation of subsequent treatment (whichever occurs first), after which they will be off the active treatment phase of the study. Long-term follow-up for disease status and survival will proceed until the subject has withdrawn consent, is lost to follow-up, or has died.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 340 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: GEM-CLARIDEX: Lenalidomide and Dexamethasone (Ld) Versus Clarithromycin / Lenalidomide [Revlimid®] / Dexamethasone (BiRd) as Initial Therapy in Multiple Myeloma
Actual Study Start Date : September 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019


Arm Intervention/treatment
Experimental: BiRd

Subjects 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.
Drug: Clarithromycin
500mg PO twice daily on days 1-28 for a 28-day cycle

Drug: Lenalidomide
25mg PO daily on days 1-21 of a 28-day cycle for patients with a calculated creatinine clearance of >60 cc/min

Drug: Dexamethasone
40mg PO will be given on days 1, 8, 15, 22 of a 28-day cycle

Active Comparator: Rd

Subjects 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 .
Drug: Lenalidomide
25mg PO daily on days 1-21 of a 28-day cycle for patients with a calculated creatinine clearance of >60 cc/min

Drug: Dexamethasone
40mg PO will be given on days 1, 8, 15, 22 of a 28-day cycle




Primary Outcome Measures :
  1. Progression free survival [ Time Frame: 2 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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:

    1. has not undergone a hysterectomy or bilateral oophorectomy; or
    2. 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)
    • Serum SGOT/AST <3.0 x upper limits of normal (ULN)ç
    • Serum SGPT/ALT <3.0 x upper limits of normal (ULN)
    • 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 (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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02575144


Contacts
Layout table for location contacts
Contact: María-Victoria Mateos-Manteca, Dr mvmateos@usal.es

Locations
Layout table for location information
Spain
CHUAC Recruiting
A Coruña, Spain
Contact: Ana Mª Vale, Dr       Ana.MA.Vale.Lopez@sergas.es   
Hospital Universitario Germans Trias i Pujol Recruiting
Badalona, Spain
Contact: Albert Oriol, Dr       aoriol@iconcologia.net   
Hospital Clinic Recruiting
Barcelona, Spain
Contact: Joan Blade, Dr       JBLADE@clinic.ub.es   
Hospital Universitario Vall d'Hebrón Recruiting
Barcelona, Spain
Contact: Mercedes Gironella, Dr       mgironella@vhebron.net   
Hospital General de Castelló Recruiting
Castellón, Spain
Contact: Adriana Gascon, Dr       adriana.gascon@uv.es   
Hospital de Cabueñes Recruiting
Gijon, Spain
Contact: Esther Gonzalez, Dr       esthergongar@yahoo.es   
Hospital Universitario Virgen de las Nieves Recruiting
Granada, Spain
Contact: Rafael Ríos, Dr       rafael.rios.sspa@juntadeandalucia.es   
H. del SAS de Jerez Recruiting
Jerez De La Frontera, Spain
Contact: Sebastián Garzón, Dr       sebastianf.garzon.sspa@juntadeandalucia.es   
Hospital de León Recruiting
León, Spain
Contact: Fernando Escalante, Dr       fescalanteb@yahoo.es   
H. U. Gregorio Marañó Not yet recruiting
Madrid, Spain
Contact: Cristina Encinas, Dr       cristina.encinas@salud.madrid.org   
Hospital del Henares Not yet recruiting
Madrid, Spain
Contact: Juan Francisco Del Campo, dr       jfran.delcampo@salud.madrid.org   
Hospital Universitario 12 de Octubre Recruiting
Madrid, Spain
Contact: Juan José Lahuerta, Dr       jjlahuerta@telefonica.net   
Hospital Universitario de la Princesa Recruiting
Madrid, Spain
Contact: Adrián Alegre, Dr       aalegre.hlpr@salud.madrid.org   
Hospital Costa del Sol Not yet recruiting
Marbella, Spain
Contact: María Casanova, Dr       mariacasanova@yahoo.com   
Hospital Geenral Universitario Morales Messeguer Recruiting
Murcia, Spain
Contact: Felipe de Arriba, DR       farriba@um.es   
Hospitral Virgen de la Arrixaca Not yet recruiting
Murcia, Spain
Contact: Valentin Cabañas, Dr       valentin.cabanas@gmail.com   
Hospital Universitario Virgen de la Victoria Recruiting
Málaga, Spain
Contact: Ricarda García, Dr       ricarda_g@yahoo.es   
Complejo Hospitalario de Navarra Recruiting
Pamplona, Spain
Contact: Jose Mª Arguiñano, Dr       jm.arguinano.perez@cfnavarra.es   
Hospital Univeristario Salamanca Recruiting
Salamanca, Spain
Contact: Mª Victoria Mateos, Dr       mvmateos@usal.es   
Hospital Marqués de Valdecilla Not yet recruiting
Santander, Spain
Contact: Guillermo Martin, Dr       guillermo.martin@scsalud.es   
Hospital Universitario de Santiago de Compostela Recruiting
Santiago de Compostela, Spain
Contact: Marta Sonia González, Dr       marta.sonia.gonzalez.perez@sergas.es   
Hospital Universitario Virgen de Valme Recruiting
Sevilla, Spain
Contact: María del Carmen Couto Caro, Dr       trcccm@yahoo.es   
Hospital Universitario Virgen del Rocío Recruiting
Sevilla, Spain
Contact: Jesús Martín, Dr       jesus.martin.sspa@juntadeandalucia.es   
Hospital Universitario de Canarias Recruiting
Tenerife, Spain
Contact: Miguel Teodoro Hernández, Dr       mthernan@ull.edu.es   
H. Clínico de Valencia Recruiting
Valencia, Spain
Contact: Anabel Teruel, Dr       ateruelc@hotmail.com   
Hospital Universitario Dr Peset Recruiting
Valencia, Spain
Contact: Javier de la Rubia, Dr       delarubia_jav@gva.es   
Hospital Universitario y Politécnico La Fe Not yet recruiting
Valencia, Spain
Contact: Isidro Jarque, Dr       jarque_isi@gva.es   
Hospital Povisa Not yet recruiting
Vigo, Spain
Contact: Cesar Soto, Dr       cesar.soto@hotmail.es   
H. U. Txagorritxu Recruiting
Vitoria, Spain
Contact: Ernesto Perez, Dr       ernesto.perezpersona@osakidetza.eus   
H. Virgen de la Concha Not yet recruiting
Zamora, Spain
Contact: Roberto Hernández, Dr       rhernandezm@saludcastillayleon.es   
Sponsors and Collaborators
PETHEMA Foundation
Cabyc, S.L.

Additional Information:
Layout table for additonal information
Responsible Party: PETHEMA Foundation
ClinicalTrials.gov Identifier: NCT02575144     History of Changes
Other Study ID Numbers: GEM-CLARIDEX
First Posted: October 14, 2015    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019

Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Clarithromycin
Dexamethasone
Dexamethasone acetate
Lenalidomide
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents