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- Klinische proef NCT01731886
Lenalidomide and Dexamethasone With/Without Stem Cell Transplant in Patients With Multiple Myeloma
21 januari 2020 bijgewerkt door: Suzanne Lentzsch, MD, Columbia University
A Randomized Clinical Trial of Lenalidomide (CC-5013) and Dexamethasone With and Without Autologous Peripheral Blood Stem Cell Transplant in Patients With Newly Diagnosed Multiple Myeloma
The study is being done to compare the combination of lenalidomide and dexamethasone followed by autologous peripheral blood stem cell transplant (PBSCT) and lenalidomide and dexamethasone without PBSCT in patients with untreated multiple myeloma.
This comparison will include how the subjects respond to each study treatment combination, and what side effects are caused by each combination.
Studie Overzicht
Toestand
Voltooid
Conditie
Gedetailleerde beschrijving
Multiple myeloma is a malignant plasma cell proliferative disorder responsible for 11, 000 deaths each year in the United States.
Approximately one third of myeloma patients develop hypercalcemia and about two thirds present with anemia.
As the second most common hematologic malignancy, myeloma remains incurable.
In the last forty years, options for therapy have included melphalan-prednisone, anthracyclines, and vinca alkaloids; however, relapse with those regimens continues to be inevitable with a median survival of 3 years.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
60
Fase
- Fase 4
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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New York
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New York, New York, Verenigde Staten, 10032
- Columbia University
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- Histologically or cytologically confirmed Multiple Myeloma, Salmon-Durie Stage II or III or International Staging System II or III that has not been previously treated.
- Bone marrow plasmacytosis with > or = 10% plasma cells, or sheets of plasma cells or a biopsy-proven plasmacytoma.
- Measurable levels of monoclonal protein (M protein): 1 g/dL Immunoglobulin G (IgG) or .5 g/dL Immunoglobulin A (IgA) on serum protein electrophoresis or > 200 mg of monoclonal light chain on a 24 hour urine protein electrophoresis.
- Age > or = 18 years.
- Life expectancy of greater than 12 months.
- Eastern Cooperative Oncology Group (ECOG) performance status < or = 2 (Karnofsky > or = 60%).
Adequate organ and marrow function as defined below:
- Hgb > or = 9 g/dL
- Absolute Neutrophil Count > or = 1,500/ ml
- Platelets > or = 50,000/mm3
- Total Bilirubin < or = 1.5 mg/dL
- Aspartate aminotransferase (AST)(SGOT) / alanine aminotransferase (ALT)(SGPT) < or = 2.5 X upper limit of normal (ULN)
- Creatinine < 2.0 mg/dL
- Creatinine Clearance > or = 50 ml/min
- Registered into the mandatory Revlimid REMS® program, and be willing and able to comply with the requirements of the REMS® program.
- Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS® program.
- Ability to understand and the willingness to sign a written informed consent document.
- Subjects with a history of prior malignancy are eligible provided there is no active malignancy and a low expectation of recurrence within 6 months.
- Must be willing and able to take prophylaxis with either aspirin at 81 mg/day or alternative prophylaxis with either low molecular weight heparin or warfarin as recommended.
- Eligible for transplant with an age up to and including 75 years.
- Subjects in Arm A who are refusing transplant can go onto Arm B and will be evaluated separately.
- Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 milli-international units per millilitre (mIU/mL) within 10 - 14 days prior to and again within 24 hours of prescribing lenalidomide and must either commit to continued abstinence or 2 acceptable methods of birth control. FCBP must also agree to ongoing pregnancy testing. Males must agree to use a latex condom.
Exclusion Criteria:
- Have had chemotherapy or radiotherapy for multiple myeloma within 4 weeks of baseline.
- Receiving any other investigational agents or therapy within 28 days of baseline.
- Brain metastases.
- Subjects who are pregnant or breast feeding.
- History of previous deep vein thrombosis or pulmonary embolism must be on anticoagulation therapy with low molecular weight heparin or warfarin at therapeutic dosages (e.g. International Normalized Ratio (INR) 2-3).
If a subject is on full-dose anticoagulants, the following criteria should be met for enrollment:
- Must not have active bleeding or pathological conditions that carry high risk of bleeding (e.g. tumor involving major vessels, known varices).
- Must not have thrombocytopenia requiring transfusion.
- Must have a platelet count > 50,000.
- Must have stable INR between 2-3.
- Smoldering myeloma or monoclonal gammopathy of undetermined significance.
- Active, uncontrolled infection.
- Active, uncontrolled seizure disorder (seizures in the last 6 months).
- Concurrent use of other anti-cancer agents or treatments.
- Positive for HIV or infectious hepatitis, type B or C.
- Hypersensitivity to thalidomide.
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Actieve vergelijker: Arm A
Subjects will receive the current standard of care treatment.
Lenalidomide and dexamethasone for four 28-day cycles followed by steam cell collection and autologous peripheral blood stem cell transplant.
After 90 days, start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses).
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Subjects deemed suitable by the principal investigator will undergo autologous peripheral blood stem cell transplantation on day 0.
Administered orally at a dose 25 mg daily on days 1-21 of each 28-day cycle.
Andere namen:
Administered orally at a dose of 40 mg daily on days 1, 8, 15, 22 of each cycle.
Andere namen:
Peripheral stem cell collection will be performed at marrow recovery, usually when white blood cell (WBC) is >2500 x 109 cells/liter; platelet count is >20 x 103/mm3.
Andere namen:
Subjects undergoing autologous peripheral blood stem cell transplant will receive melphalan 200 mg/m2 intravenously on days -2 and -1 or only on day -2.
Andere namen:
Subjects will receive G-CSF subcutaneously daily beginning on day 5 and until blood counts recover.
Andere namen:
Subjects may receive up to the maximum recommended high-dose of cyclophosphamide at 4 gm/m2 intravenously.
Andere namen:
Mesna will be provided with the cyclophosphamide.
Andere namen:
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Actieve vergelijker: Arm B
Subjects will receive the new treatment that will be compared with the standard of care.
Lenalidomide and dexamethasone for eight 28-day cycles.
After four cycles your stem cells will be collected (stem cell collection).
After an additional four cycles of lenalidomide (a total of 8 cycles), start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses).
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Administered orally at a dose 25 mg daily on days 1-21 of each 28-day cycle.
Andere namen:
Administered orally at a dose of 40 mg daily on days 1, 8, 15, 22 of each cycle.
Andere namen:
Peripheral stem cell collection will be performed at marrow recovery, usually when white blood cell (WBC) is >2500 x 109 cells/liter; platelet count is >20 x 103/mm3.
Andere namen:
Subjects may receive up to the maximum recommended high-dose of cyclophosphamide at 4 gm/m2 intravenously.
Andere namen:
Mesna will be provided with the cyclophosphamide.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Complete Response Rate
Tijdsspanne: 3 years
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The primary objective of this study is to determine the complete response rate of lenalidomide and low-dose dexamethasone versus that of lenalidomide and low-dose dexamethasone followed by autologous peripheral blood stem cell transplant in patients with newly diagnosed multiple myeloma (will include unconfirmed complete response (CR), CR and stringent complete response (sCR)).
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3 years
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Overall Survival Rate (OS)
Tijdsspanne: 4 years
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To compare overall survival in subjects receiving autologous peripheral blood stem cell transplant after undergoing induction therapy with lenalidomide and dexamethasone versus in those receiving only lenalidomide and dexamethasone, followed by lenalidomide maintenance in both arms.
Only patients who achieved at least a partial response (PR) following 4 cycles of induction were included in the analysis.
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4 years
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Overall Survival Rate (OS)
Tijdsspanne: 2 years
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To compare overall survival in subjects receiving autologous peripheral blood stem cell transplant after undergoing induction therapy with lenalidomide and dexamethasone versus in those receiving only lenalidomide and dexamethasone, followed by lenalidomide maintenance in both arms.
Only patients who achieved at least a partial response (PR) following 4 cycles of induction were included in the analysis.
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2 years
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Progression Free Survival (PFS)
Tijdsspanne: 4 years
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PFS is the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.
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4 years
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Progression Free Survival (PFS)
Tijdsspanne: 2 years
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PFS is the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.
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2 years
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Suzanne Lentzsch, MD, Columbia University
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 september 2012
Primaire voltooiing (Werkelijk)
11 april 2017
Studie voltooiing (Werkelijk)
11 april 2017
Studieregistratiedata
Eerst ingediend
19 november 2012
Eerst ingediend dat voldeed aan de QC-criteria
19 november 2012
Eerst geplaatst (Schatting)
22 november 2012
Updates van studierecords
Laatste update geplaatst (Werkelijk)
5 februari 2020
Laatste update ingediend die voldeed aan QC-criteria
21 januari 2020
Laatst geverifieerd
1 januari 2020
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
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
- Autonome agenten
- Agenten van het perifere zenuwstelsel
- Ontstekingsremmende middelen
- Antireumatische middelen
- Antineoplastische middelen
- Immunosuppressieve middelen
- Immunologische factoren
- Anti-emetica
- Gastro-intestinale middelen
- Glucocorticoïden
- Hormonen
- Hormonen, hormoonvervangers en hormoonantagonisten
- Antineoplastische middelen, hormonaal
- Antineoplastische middelen, alkylering
- Alkyleringsmiddelen
- Myeloablatieve agonisten
- Angiogenese-remmers
- Angiogenese modulerende middelen
- Groei stoffen
- Groeiremmers
- Adjuvantia, immunologisch
- Dexamethason
- Cyclofosfamide
- Lenalidomide
- Lenograstim
- Melfalan
Andere studie-ID-nummers
- AAAJ2355
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Beschrijving IPD-plan
Individual participant data (IPD) will be coded and shared with the University of Pittsburgh at the end of the trial.
IPD-tijdsbestek voor delen
After completion of the study.
IPD-toegangscriteria voor delen
All data will be coded with study identifiers.
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Ja
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
product vervaardigd in en geëxporteerd uit de V.S.
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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)