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A Single Arm, Open-Label, Phase 2 Study of Melflufen in Combination With Dexamethasone in Patients With Relapsed Refractory Multiple Myeloma Who Are Refractory to Pomalidomide and/or Daratumumab - HORIZON

Studio Clinico

Patologia: Mieloma

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: II

Richiesta mandatoria di tessuto: No

Linee di trattamento: Terza/N linea

Criteri di inclusione: 

- Male or female, age 18 years or older
- A prior diagnosis of multiple myeloma with documented disease progression
- Measurable disease based on either of a) serum monoclonal protein by protein electrophoresis (SPEP), b) monoclonal protein in the urine on 24-hour urine electrophoresis (UPEP), and/or c) serum immunoglobulin free light chain combined with abnormal serum immunoglobulin kappa to lambda free light chain ratio
- A minimum of 2 prior lines of therapy including an IMiD and a PI and is refractory to pomalidomide and/or daratumumab
- Life expectancy of ≥ 6 months
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Female of child bearing potential (FCBP) and non-vasectomized male agree to practice appropriate methods of birth control
- Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information
- 12-lead ECG with QTc interval within defined limit
- Acceptable laboratory results during screening and prior to first study drug administration of the following parameters: absolute neutrophil count (ANC), platelet count, hemoglobin, total bilirubin, aspartate transaminase (AST/SGOT) and alanine transaminase (ALT/SGPT), renal function based on estimated creatinine clearance
- Must have, or accept to have, an acceptable central catheter for infusion of melflufen

Criteri di esclusione: 

- Evidence of mucosal or internal bleeding and/or is platelet transfusion refractory
- Any medical conditions that, in the Investigator's opinion, would impose excessive risk to the patient or would adversely affect his/her participating in this study
- Known active infection requiring parenteral or oral anti-infective treatment within defined period
- Primary refractory disease
- Other malignancy diagnosed or requiring treatment within the defined period with specific exceptions
- Pregnant or breast-feeding females
- Serious psychiatric illness, active alcoholism, or drug addiction that may hinder or confuse compliance or follow-up evaluation
- Known HIV or active hepatitis B or C viral infection
- Concurrent symptomatic amyloidosis or plasma cell leukemia
- POEMS syndrome [plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein (M-protein) and skin changes]
- Previous cytotoxic therapies, including cytotoxic investigational agents, for multiple myeloma within defined values prior to start of study treatment
- Residual side effects to previous therapy over specific grade prior to initiation of therapy
- Prior autologous or allogeneic stem cell transplant within defined period of initiation of therapy
- Prior allogeneic stem cell transplant with active graft-versus-host- disease (GVHD).
- Prior major surgical procedure or radiation therapy within specified period of the first dose of study treatment (with defined exception).
- Known intolerance to steroid therapy

Schema di trattamento: 

Melflufen 40 mg Day 1 and dexamethasone 40 mg (reduced dose for patients 75 years or older) on Days 1, 8, 15 and 22 of each 28-day cycle

Trattamento sperimentale: 

melflufen+dexamethasone

Trattamento di controllo: 

NA

Obiettivi primari dello studio: 

Overall Response Rate (ORR) [Time Frame: From date of response until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months]

The overall response rate (ORR) will be estimated as the proportion of patients in each group who achieve sCR, CR, VGPR, or PR as their best response

Centri partecipanti

Nord Italia

Ospedale S.Orsola Malpighi, Università di Bologna
Via Pietro Albertoni 15 - 40138 Bologna - BO

Riferimento: Prof. Michele Cavo
Email: michele.cavo@unibo.it

 

AOU Città della Salute e della Scienza di Torino
Corso Bramante 88 - 10126 Torino - TO

Riferimento: Dr.ssa Alessandra Larocca
Email: alessandra.larocca@unito.it

Informazioni Generali

Protocollo

Numero di iscrizione a registro: NCT02963493

Data di inserimento: 21.01.2019

Promotore

CRO

/

Principal Investigator ITALIA

Policlinico Sant'Orsola Malpighi - Istituto di Ematologia L.e A. Seràgnoli - Bologna

Riferimento: Prof. Michele Cavo

Telefono: 0512143537

Email: michele.cavo@unibo.it

Localita: Bologna

 

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