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- Klinische proef NCT01159574
Study of Decadron, Biaxin, and Pomalidomide in Relapsed/Refractory Myeloma
A Phase II Study of Dexamethasone (DECADRON®), Clarithromycin (BIAXIN®), and Pomalidomide (CC-4047®) for Subjects With Relapsed or Refractory Multiple Myeloma
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
This phase II study is a treatment program for patients with relapsed or refractory multiple myeloma who have had prior treatment with lenalidomide. Up to 54 patients will be enrolled. Patients who sign informed consent form and fulfill all eligibility criteria will be enrolled.
ClaPd therapy:
Dexamethasone (40mg ) on days 1, 8, 15, 22 of a 28-day cycle. Clarithromycin given orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle.
Pomalidomide will be given 4mg daily for days 1-21 of each 28 day cycle.
Serial clinic visits and laboratory measurements will be performed to monitor for treatment response. Those patients who demonstrate progression of disease at any point during ClaPd therapy will be taken off study.
At the end of every cycle (which may coincide with day 1 of the new cycle), response and toxicity will be evaluated. During cycle 1, patients will have labwork done weekly (CBC with differential and blood electrolytes). All patients will remain on study until disease progression or side effects become excessive. Patients who achieve a stable plateau may be taken off study if eligible to proceed to high dose chemotherapy and autologous stem cell transplantation.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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New York
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New York, New York, Verenigde Staten, 10065
- Weill Cornell Medical College
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Subject must voluntarily sign and understand written informed consent.
- Age > 18 years at the time of signing the consent form.
- Histologically confirmed MM
- Relapsed or refractory myeloma, progression of disease either after prior therapy or lack of response to currently used therapy.
- Relapsed or progressive disease after at least 3 prior therapeutic treatments or regimens for multiple myeloma.
- Must have been previously treated with lenalidomide and has been determined to be refractory, resistant, or relapsed.
- Measurable disease as defined by > 0.5 g/dL serum monoclonal protein, >0.1 g/dL serum free light chains, >0.2 g/24 hrs urinary M-protein excretion, and/or measurable plasmacytoma(s).
- Karnofsky performance status ≥70% (>60% if due to bony involvement of myeloma
- Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours of prescribing lenalidomide and thalidomide (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 4 weeks 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. See Appendix V: Pomalidomide Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods. †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).
- Able to take aspirin daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin). †
- 1ife expectancy ≥ 3 months
- Subjects must meet the following laboratory parameters:
Absolute neutrophil count (ANC) ≥750 cells/mm3 (1.0 x 109/L) Platelets count ≥ 50,000/mm3 (75 x 109/L) Serum SGOT/AST ≤ 2.0 x upper limits of normal Serum SGPT/ALT <3.0 x upper limits of normal (ULN) Serum creatinine ≤ 2.5 x upper limits of normal Serum total bilirubin ≤ 1.5 x upper limits of normal
Exclusion Criteria:
- Patients with non-secretory MM (no measurable monoclonal protein, free light chains, and/or M-spike in blood or urine).
- Prior history of other malignancies (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless disease free for ≥ 5 years.
- Myocardial infarction within 6 months prior to enrollment, or NYHA(New York Hospital Association) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
- Known HIV infection
- Known hepatitis B or hepatitis C infection.
- Active viral or bacterial infections or any coexisting medical problem that would significantly increase the risks of this treatment program.
- Any coexisting medical problem or laboratory evaluation that, in the treating physician's or principal investigator's opinion, makes the patient unsuitable to participate in this clinical trial.
- Known hypersensitivity to thalidomide or lenalidomide.
- History of thromboembolic event within the past 6 months prior to enrollment.
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- Pregnant or breast feeding females.
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
- Use of any other experimental drug or therapy within 14 days of baseline.
- Known hypersensitivity to thalidomide or lenalidomide.
- The development of erythema nodorum if characterized by a desquamating rash while taking thalidomide, CC-4047 or similar drugs.
- Any prior use of CC-4047.
- Concurrent use of other anti-cancer agents or treatments.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: all patients
ClaPd therapy: Dexamethasone (40mg ) will be given on days 1, 8, 15, 22 of a 28-day cycle. Clarithromycin (Biaxin®) will be given orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle. Pomalidomide will be given 4mg daily for days 1-21 of each 28 day cycle. Dosing will be in the morning at approximately the same time each day. |
40mg will be given on days 1, 8, 15, 22 of a 28-day cycle
Andere namen:
orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle
Andere namen:
orally 4mg daily for days 1-21 of each 28 day cycle
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Overall Response Rate
Tijdsspanne: from baseline to cycle with maximum response, which was achieved on average after 2 cycles
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Best response rate was recorded for all patients, using the IMWG criteria.
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from baseline to cycle with maximum response, which was achieved on average after 2 cycles
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Time to Maximum Response, Expressed as Number of Cycles of Treatment to Maximum Response
Tijdsspanne: From baseline to cycle of maximum response, which occurred on average after 2 cycles; 1 cycle = 28 days
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From baseline to cycle of maximum response, which occurred on average after 2 cycles; 1 cycle = 28 days
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Time to Disease Progression (Progression Free Survival)
Tijdsspanne: From start of treatment, to date of disease progression
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From start of treatment, to date of disease progression
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Medewerkers en onderzoekers
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Ruben Niesvizky, MD, Weill Medical College of Cornell University
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Hart-en vaatziekten
- Vaatziekten
- Ziekten van het immuunsysteem
- Neoplasmata per histologisch type
- Neoplasmata
- Lymfoproliferatieve aandoeningen
- Immunoproliferatieve aandoeningen
- Hematologische ziekten
- Hemorragische aandoeningen
- Hemostatische aandoeningen
- Paraproteïnemieën
- Bloed eiwit stoornissen
- Multipel myeloom
- Neoplasmata, plasmacel
- Fysiologische effecten van medicijnen
- Moleculaire mechanismen van farmacologische werking
- Anti-infectieuze middelen
- Autonome agenten
- Agenten van het perifere zenuwstelsel
- Enzymremmers
- Ontstekingsremmende middelen
- Antineoplastische middelen
- Immunologische factoren
- Anti-emetica
- Gastro-intestinale middelen
- Glucocorticoïden
- Hormonen
- Hormonen, hormoonvervangers en hormoonantagonisten
- Antineoplastische middelen, hormonaal
- Angiogenese-remmers
- Angiogenese modulerende middelen
- Groei stoffen
- Groeiremmers
- Antibacteriële middelen
- Cytochroom P-450 CYP3A-remmers
- Cytochroom P-450 enzymremmers
- Eiwitsyntheseremmers
- Dexamethason
- Pomalidomide
- Claritromycine
Andere studie-ID-nummers
- 1004011012
- PO-MM-PI-0023 (Ander subsidie-/financieringsnummer: Celgene)
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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Klinische onderzoeken op Multipel myeloom
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University of ArkansasVoltooidMEERDERE MYELOMAVerenigde Staten
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PETHEMA FoundationGlaxoSmithKlineWervingTERUGVALLEN EN/OF REFRACTAIRE MEERDERE MYELOMASpanje
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Mario BoccadoroActief, niet wervend
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Beth Israel Deaconess Medical CenterAmgenVoltooidAML | MDS | CLL | ALLE | CML Chronic Phase, Accelerated Phase, or Blast Crisis | RELAPSED NON-HODGKIN'S OR HODGKIN'S LYMPHOMA | APLASTIC ANEMIA | MEERDERE MYELOMA | MYELOPROLIFERATIVE DISORDER (P Vera, CMML, ET)
Klinische onderzoeken op dexamethasone
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Ottawa Hospital Research InstituteVoltooidPijn syndroom | Borstkanker in een vroeg stadiumCanada
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Universitätsklinikum Hamburg-EppendorfGemeinsamer Bundesausschuss (G-BA); Staburo GmbHWerving
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Vanderbilt University Medical CenterBeëindigdAstma | KruisVerenigde Staten
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Shanghai Jiao Tong University Affiliated Sixth...VoltooidAnalgesie | Tijd | Brachiaal Plexus Blok | Schouder Chirurgie | Dexamethason | Intraveneus drugsgebruikChina
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Centre hospitalier de l'Université de Montréal...VoltooidPreventie van overgevoeligheidsreacties op paclitaxelCanada
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Dr. Stephen ChoiThe Physicians' Services Incorporated FoundationVoltooidSchouder Chirurgie | Zenuw blokCanada
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Poznan University of Medical SciencesWervingPols verwondingen | Hand verwondingen | Handverwondingen en aandoeningen | Handziekte | Pols ziektePolen
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University of BelgradeVoltooid
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General Hospital of Ningxia Medical UniversityNog niet aan het werven
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Cairo UniversityOnbekend