Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
477
Countries
1
Sites
42
NEWLY DIAGNOSED MULTIPLE MYELOMA (MM) PATIENTS ELEGIBLE FOR AUTOLOGOUS TRANSPLANT
To determine the efficacy, in term of at least very good partial response (VGPR), of the combination of Carfilzomib and dexamethasone with cyclophosphamide or lenalidomide after 4 cycles of induction treatment in newly diagnosed MM patients eligible for autologous transplantation (ASCT). To determine the progression-fr…
Key facts
- Sponsor
- Universita' Degli Studi Di Torino
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 12 Jan 2015 → 30 Mar 2026
- Decision date (initial)
- 2025-01-21
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Amgen (Europe) GmbH - ORG-100029468 - LOC-100082898 · Celgene International II S.a.r.l. ORG-100017122-LOC-100025921
External identifiers
- EU CT number
- 2024-516630-35-01
- EudraCT number
- 2014-000782-53
- ClinicalTrials.gov
- NCT02203643
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety
To determine the efficacy, in term of at least very good partial response (VGPR), of the combination of Carfilzomib and dexamethasone with cyclophosphamide or lenalidomide after 4 cycles of induction treatment in newly diagnosed MM patients eligible for autologous transplantation (ASCT).
To determine the progression-free survival in the 2 maintenance arms.
Secondary objectives 1
- Key secondary objectives: To determine the stringent complete response (sCR) rate in the 3 arms after complete induction/consolidation therapy (induction, ASCT and consolidation for the transplant arms and after 12 cycles in the long treatment arm) To determine the progression-free survival in in the 3 induction/consolidation arms Other secondary objectives: To determine Minimal Residual Disease (MRD) negativity rate in the 3 arms after complete primary therapy (induction, ASCT and consolidation for the transplant arms and after 12 cycles in the long treatment arm). To determine the Sustained MRD To determine the response in the 3 arms after complete primary therapy (induction, ASCT and consolidation for the transplant arms and after 12 cycles in the long treatment arm). To determine the safety in the 3 induction/consolidation arms (including ASCT) and in the 2 maintenance arms. To determine the time to next therapy in the 3 induction/consolidation arms and in the 2 maintenance arms. To determine the time to progression in the 3 induction/consolidation arms and in the 2 maintenance arms. To determine the progression-free survival 2 in the 3 induction/consolidation arms and in the 2 maintenance arms. To determine overall survival in the 3 induction/consolidation arms and in the 2 maintenance arms. To determine the duration of response (DOR) in the 3 induction/consolidation arms and in the 2 maintenance arms. Determine the success of stem cell harvest according to baseline characteristics and therapy Determine whether tumor response and outcome may change in subgroups with different prognosis according to current prognostic factors To perform explorative comparative analyses between subgroups of patients, defined according to known prognostic factors
Conditions and MedDRA coding
NEWLY DIAGNOSED MULTIPLE MYELOMA (MM) PATIENTS ELEGIBLE FOR AUTOLOGOUS TRANSPLANT
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10028228 | Multiple myeloma | 10029104 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | This protocol is a phase II randomized, multicenter study designed to assess safety and efficacy This protocol is a phase II randomized, multicenter study designed to assess the safety and the efficacy of different carfilzomib combinations in newly diagnosed MM patients eligible for autologous transplantation (ASCT).
|
Randomised Controlled | None | ARM A: CCyd: Patients will be randomized to receive 4 cycles of CCyd followed by ASCT and subsequent consolidation with 4 cycles of CCyd vs 4 cycles of CRd followed by ASCT and subsequent consolidation with 4 cycles of CRd vs 12 cycles of continuous CRd. At the end of consolidation/12 cycles of CRd treatment patients will be randomized to receive R vs CR as maintenance treatment. Treatment schedule for induction/consolidation: All patients will be randomized to receive: ARM A: CCyd 1. Carfilzomib = 20 mg/m2 IV on days 1-2 cycle 1 only, followed by 36 mg/m2 IV once daily on days 8-9, 15-16 cycle 1 then for all subsequent doses 36 mg/m2 IV once daily on days 1-2, 8-9, 15-16. 2. Cyclophosphamide = 300 mg/m2 orally on days 1, 8, 15. 3. Dexamethasone = 20 mg orally or IV on days 1, 2, 8, 9, 15, 16, 22, 23. Repeat for 4 28-day cycles All patients will be given Cyclophosphamide at the dose of 2 g/m2, followed by G-CSF for stem cell collection. Cyclophosphamide will start 4-6 weeks after day 21 of cycle 4. Stem cell collection will be performed as soon as CD34+ cells are present in peripheral blood, which is usually between 9-14 days after first day of Cyclophosphamide. Stem cells will be harvested at a minimum of 4 x 106 CD34+ cells/kg and cryopreserved. In case insufficient stem cells are collected the procedure may be repeated or alternatively bone marrow stem cell collection may be performed or Plerixafor may be used. 4-6 weeks after chemotherapy patients will be treated with High Dose Melphalan followed by autologous stem cell reinfusion according to the schedule below. 90-120 days after Melphalan treatment: 1. Carfilzomib = 36 mg/m2 IV once daily on days 1-2, 8-9, 15-16. 2. Cyclophosphamide = 300 mg/m2 orally on days 1, 8, 15. 3. Dexamethasone = 20 mg orally or IV on days 1, 2, 8, 9, 15, 16, 22, 23. Repeat for 4 28-day cycles In case patients do not have the criteria to start the consolidation treatment (ANC ≥1.0x109/L and platelets ≥75 x109/L and no grade >1 extra-hematologic toxicity) within 120 days from Melphalan infusion, they will go on with the maintenance treatment. ARM B: CRd: ARM B: CRd 1. Carfilzomib = 20 mg/m2 IV on days 1-2 cycle 1 only, followed by 36 mg/m2 IV once daily on days 8-9, 15-16 cycle 1 then for all subsequent doses 36 mg/m2 IV once daily on days 1-2, 8-9, 15-16. 2. Lenalidomide= 25 mg PO daily on days 1-21. 3. Dexamethasone = 20 mg orally or IV on days 1, 2, 8, 9, 15, 16, 22, 23. Repeat for 4 28-day cycles All patients will be given Cyclophosphamide at the dose of 2 g/m2, followed by G-CSF for stem cell collection. Cyclophosphamide will start 4-6 weeks after day 21 of cycle 4. Stem cell collection will be performed as soon as CD34+ cells are present in peripheral blood, which is usually between 9-14 days after first day of Cyclophosphamide. Stem cells will be harvested at a minimum of 4 x 106 CD34+ cells/kg and cryopreserved. In case insufficient stem cells are collected the procedure may be repeated or alternatively bone marrow stem cell collection may be performed or Plerixafor may be used. 4-6 weeks after chemotherapy patients will be treated with High Dose Melphalan followed by autologous stem cell reinfusion according to the schedule below. Agent Dose/day Route Melphalan 200 mg/ m² day -2 i.v. rapid infusion Stem cell infusion Minimum of 2 x 106CD34+cells/kg day 0 90-120 days after Melphalan treatment: 1. Carfilzomib = 36 mg/m2 IV once daily on days 1-2, 8-9, 15-16. 2. Lenalidomide= 25 mg PO daily on days 1-21. 3. Dexamethasone = 20 mg orally or IV on days 1, 2, 8, 9, 15, 16, 22, 23. Repeat for 4 28-day cycles In case patients do not have the criteria to start the consolidation treatment (ANC ≥1.0x109/L and platelets ≥75 x109/L and no grade >1 extra-hematologic toxicity) within 120 days from Melphalan infusion, they will go on with the maintenance treatment. ARM C: CRd long treatment: ARM C: CRd long treatment 1. Carfilzomib = 20 mg/m2 IV on days 1-2 cycle 1 only, followed by 36 mg/m2 IV once daily on days 8-9, 15-16 cycle 1 then for all subsequent doses 36 mg/m2 IV once daily on days 1-2, 8-9, 15-16. 2. Lenalidomide= 25 mg PO daily on days 1-21. 3. Dexamethasone = 20 mg orally or IV on days 1, 2, 8, 9, 15, 16, 22, 23. Repeat for 4 28-days cycles All patients will be given Cyclophosphamide at the dose of 2 g/m2, followed by G-CSF. Cyclophosphamide will start 4-6 weeks after day 21 of cycle 4. Stem cell collection will be performed as soon as CD34+ cells are present in peripheral blood, which is usually between 9-14 days after first day of Cyclophosphamide. Stem cells will be harvested at a minimum of 4 x 106 CD34+ cells/kg and cryopreserved. In case insufficient stem cells are collected the procedure may be repeated or alternatively bone marrow stem cell collection may be performed or Plerixafor may be used. 30-60 days after Cyclophosphamide 1. Carfilzomib = 36 mg/m2 IV once daily on days 1-2, 8-9, 15-16. 2. Lenalidomide= 25 mg PO daily on days 1-21. 3. Dexamethasone = 20 mg orally or IV on days 1, 2, 8, 9, 15, 16, 22, 23. Repeat for 8 28-days cycles. Treatment schedule for maintenance: After the end of consolidation all patients will be randomized to receive: 1. Lenalidomide 10 mg PO daily on days 1-21 every 28 days. 2. Lenalidomide 10 mg PO daily on days 1-21 AND Carfilzomib* 70 mg/m2 IV once daily on days 1, 15 every 28 days for patients that have started maintenance within 6 months from amendment 5.0 approval. OR 2. Lenalidomide 10 mg PO daily on days 1-21 AND Carfilzomib* 36 mg/m2 IV once daily on days 1, 2, 15, 16 every 28 days for patients that have started maintenance more than 6 months before the amendment 5.0 approval. Patients will receive carfilzomib maintenance for a maximum of 2 years and lenalidomide maintenance until any sign of progression or intolerance. Patients that decreased carfilzomib and/or lenalidomide dose in the induction/consolidation treatment will continue with a reduced drug dose during the maintenance period. Maintenance can only start if ANC ≥ 0.75 x 109/l and platelets > 50 x 109/l. Moreover all extra-hematological toxicities should be resolved to ≤ grade 1. * Patients will receive 8 mg of dexamethasone as pre-medication before carfilzomib administration during the first cycle of maintenance and for subsequent cycles according to physician opinion. |
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-516630-35-00 | A MULTICENTER, RANDOMIZED, OPEN LABEL PHASE II STUDY OF CARFILZOMIB, CYCLOPHOSPHAMIDE AND DEXAMETHASONE (CCyd) as pre transplant INDUCTION and post transplant consolidation or CARFILZOMIB, LENALIDOMIDE AND DEXAMETHASONE (CRd) as pre transplant INDUCTION and post transplant consolidation or continuous treatment with CARFILZOMIB, LENALIDOMIDE AND DEXAMETHASONE (12 cycles) without transplant, all followed by MAINTENANCE with LENALIDOMIDE (R) versus LENALIDOMIDE AND CARFILZOMIB (CR) IN NEWLY DIAGNOSED MULTIPLE MYELOMA (MM) PATIENTS ELEGIBLE FOR AUTOLOGOUS TRANSPLANT | Universita' Degli Studi Di Torino |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Age ≥ 18 years Newly diagnosed MM based on standard CRAB criteria (see appendix B). Patient < 65 years* eligible for ASCT. Patient has measurable disease according to IMWG criteria. Patient has given voluntary written informed consent. Patient agrees to use acceptable methods for contraception. Patient has a Karnofsky performance status ≥ 60% (see appendix G). Pretreatment clinical laboratory values within 30 days of enrollment: Platelet count ≥75 x 109/L (≥50 x 109 /L if myeloma involvement in the bone marrow is > 50%) Absolute neutrophil count (ANC) ≥ 1 x 109/L without the use of growth factors Corrected serum calcium ≤14 mg/dL (3.5 mmol/L) Alanine transaminase (ALT): ≤ 3 x the ULN Aspartate transaminase (AST): ≤ 3 x the ULN Total bilirubin: ≤ 2 x the ULN Calculated or measured creatinine clearance: ≥ 30 mL/minute. LVEF ≥ 40%. 2-D transthoracic echocardiogram (ECHO) is the preferred method of evaluation. Multigated Acquisition Scan (MUGA) is acceptable if ECHO is not available *until the day before the 66th birthday Life expectancy ≥ 3 months
Exclusion criteria 1
- Previous treatment with anti-myeloma therapy (does not include radiotherapy, bisphosphonates, or a single short course of steroid < to the equivalent of dexamethasone 40 mg/day for 4 days) Patients with non-secretory MM unless serum free-light chains are present and the ratio is abnormal or a plasmocytoma with minimum largest diameters of > 2 cm Patients ineligible for autologous transplantation Pregnant or lactating females Presence of: Clinical active infectious hepatitis type A, B, C or HIV Acute active infection requiring antibiotics or infiltrative pulmonary disease Myocardial infarction or unstable angina ≤ 4 months or other clinically significant heart disease Peripheral neuropathy or neuropathic pain grade 2 or higher, as defined by National Cancer Institute Common Toxicity Criteria (NCI CTC) 4.0 (Appendix A) Known history of allergy to Captisol ® (a cyclodextrin derivative used to solubilize carfilzomib) Contraindication to any of the required drugs or supportive treatments Invasive malignancy within the past 3 years Serious medical condition, laboratory abnormality or psychiatric illness that prevented the subject from the enrollment or place the subject at unacceptable risk.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- All patients will be included in the Intent-to-Treat (ITT) analysis. Efficacy will be assessed by considering VGPR or better (VGPR, sCR and CR) at cycle 4 in the 3 arms. Assessment of VGPR rate will be performed according to the criteria of the International Myeloma Working Group (Appendix D). To determine the progression-free survival in the 2 maintenance arms.
Secondary endpoints 1
- To determine the stringent complete response (sCR) rate in the 3 arms after complete induction/consolidation therapy (induction, ASCT and consolidation for the transplant arms and after 12 cycles in the long treatment arm) To determine the progression-free survival in in the 3 induction/consolidation arms.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 5
PRD9264283 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 15120 mg milligram(s)
- Max treatment duration
- 72 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/07/391/002
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD9264284 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 5 mg milligram(s)
- Max total dose
- 7560 mg milligram(s)
- Max treatment duration
- 72 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/07/391/001
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD9264293 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 2.5 mg milligram(s)
- Max total dose
- 3780 mg milligram(s)
- Max treatment duration
- 72 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/07/391/005
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Kyprolis 60 mg powder for solution for infusion
PRD3374183 · Product
- Active substance
- Carfilzomib
- Substance synonyms
- PR-171
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 36 mg/m2 milligram(s)/square meter
- Max total dose
- 13024 mg/m2 milligram(s)/square meter
- Max treatment duration
- 32 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XG02 — -
- Marketing authorisation
- EU/1/15/1060/001
- MA holder
- AMGEN EUROPE B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/08/548
- Modified vs. Marketing Authorisation
- No
PRD9264271 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 6300 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/07/391/004
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universita' Degli Studi Di Torino
- Sponsor organisation
- Universita' Degli Studi Di Torino
- Address
- Via Nizza 52
- City
- Turin
- Postcode
- 10126
- Country
- Italy
Scientific contact point
- Organisation
- Universita' Degli Studi Di Torino
- Contact name
- Clinical Trial Office
Public contact point
- Organisation
- Universita' Degli Studi Di Torino
- Contact name
- Clinical Trial Office
Third parties 5
| Organisation | City, country | Duties |
|---|---|---|
| Dana-Farber Cancer Institute Inc. ORG-100022897
|
Boston, United States | Laboratory analysis |
| Celgene International II SARL ORG-100017122
|
Couvet, Switzerland | Other |
| Amgen (Europe) GmbH ORG-100029468
|
Rotkreuz, Switzerland | Other |
| Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino ORG-100010457
|
Turin, Italy | Laboratory analysis |
| Universita' Degli Studi Di Torino ORG-100008619
|
Turin, Italy | Laboratory analysis |
Locations
1 EU/EEA country · 42 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ended | 477 | 42 |
| Rest of world | — | 0 | — |
Investigational sites
University Hospital Consorziale Policlinico
U.O. di Ematologia con Trapianto, Piazza Giulio Cesare 11, 70124, Bari
Azienda Sanitaria Universitaria Giuliano Isontina
S.C. II Medicina-Ematologia - Ospedale Riuniti di Trieste, Strada Di Fiume 447, 34149, Trieste
Grande Ospedale Metropolitano Bianchi Melacrino Morelli
Divisione di Ematologia, Viale Europa, 89133, Reggio Calabria
Azienda Sanitaria Locale Roma 2
Divisione Ematologia Ospedale Sant'Eugenio, Via Dei Monti Tiburtini 385, 00157, Rome
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I G M Lancisi G Salesi
Clinica di Ematologia, Via Filippo Corridoni 11, 60123, Ancona
Azienda Ospedaliero Universitaria Renato Dulbecco
U.O. di Oncologia Medica, Viale Tommaso Campanella 115, 88100, Catanzaro
Azienda Sanitaria Locale Di Pescara
U.O. di Ematologia Generale Azienda USL di Pescara, Via Renato Paolini 47, 65124, Pescara
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Divisione di ematologia, Viale Del Policlinico 155, 00161, Rome
Azienda USL IRCCS Di Reggio Emilia
Ematologia, Viale Risorgimento 80, 42123, Reggio Emilia
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
Divisione di Ematologia-A.O. Giovanni Papa XXIII, Piazza Oms 1, 24127, Bergamo
Azienda Ospedaliera-Universitaria Di Cosenza
U.O. Ematologia Presidio Ospedaliero dell'Annunziata, Via Felice Migliori 1, 87100, Cosenza
Azienda Ospedaliero Universitaria Parma
Ematologia, Viale Antonio Gramsci 14, 43126, Parma
IRCCS Ospedale Policlinico San Martino
Unità Operativa di Ematologia-A.O.U. San Martino, Largo Rosanna Benzi 10, 16132, Genoa
Fondazione IRCCS Istituto Nazionale Dei Tumori
Ematologa - Trapianto di Midollo Osseo, Via Giacomo Venezian 1, 20133, Milan
Azienda Unita Sanitaria Locale Della Romagna
Ematologia, Viale Luigi Settembrini 2, 47923, Rimini
Azienda Ulss 3 Serenissima
U.O.Ematologia - Ospedale dell'Angelo - Mestre, Mestre-Venezia, Via Don Federico Tosatto 147, Venice
Ospedale San Francesco – ASSL Nuoro ATS Regione Sardegna
Ematologia Ospedale San Francesco, Via Salvatore Mannironi, Italy, Nuoro
Azienda Ospedaliera S Maria Di Terni
S.C. Oncoematologia A.O. Santa Maria, Viale Tristano Di Joannuccio 1, 05100, Terni
Universita' Campus Bio-medico Di Roma
Area di Ematologia - Policlinico Universitario - Campus bio Medico di Roma, Via Alvaro Del Portillo 200, 00128, Rome
Azienda Ospedaliera Universitaria Senese
Divisione di Ematologia, Viale Mario Bracci 2, 53100, Siena
Central Hospital Of Bolzano
Divisione di Ematologia-CTMO, Via Lorenz Boehler 5, 39100, Bolzano
Istituto Di Ricovero E Cura A Carattere Scientifico Centro Di Riferimento Oncologico Della Basilicata
[email protected], Via Padre Pio 1, 85028, Rionero In Vulture
Azienda Ospedaliera Di Perugia
Divisione di Ematologia, Piazzale Giorgio Menghini 9, 06129, Perugia
Azienda Ospedaliera di Padova
Divisione di Ematologia e Immunologia Clinica Universitaria, Via Nicolo' Giustiniani 2, 35128, Padova
Azienda Ospedaliero Universitaria Di Modena
Reparto di Ematologia, Largo Del Pozzo 71, 41124, Modena
Azienda Ospedaliera Universitaria Gaetano Martino Messina
Divisione di Ematologia, Via Consolare Valeria N 1, 98124, Messina
I.F.O. Istituti Fisioterapici Ospitalieri
U.O.C. Ematologia - Istituto Nazionale dei Tumori Regina Elena, Via Elio Chianesi N 53, 00144, Rome
Azienda Ospedaliero-Universitaria Ss.Antonio E Biagio E C.Arrigo Alessandria
Dipartimento di Ematologia e Medicina Trasfusionale, Via Venezia 16, 15121, Alexandria
Azienda Ospedaliera Di Rilievo Nazionale Antonio Cardarelli
Ematologia con TMO, Via Antonio Cardarelli 9, 80131, Naples
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
[email protected], Via Pietro Albertoni 15, 40138, Bologna
Azienda Sanitaria Locale Della Provincia Di Lecce
Ematologia-A.O. “Cardinale G.Panico” -Tricase, Via Antonio Miglietta 5, 73100, Lecce
IRCCS Ospedale Policlinico San Martino
Clinica Ematologica -Ospedale San Martino -Università di Genova, Largo Rosanna Benzi 10, 16132, Genoa
Istituto Di Candiolo Fondazione Del Piemonte Per L'Oncologia IRCCS
Divisione di Ematologia, Strada Provinciale 142 Orba Km 3,95, 10060, Candiolo
ASST Grande Ospedale Metropolitano Niguarda
S.C. Ematologia -Ospedale Niguarda Cà Grande, Piazza Dell'ospedale Maggiore 3, 20162, Milan
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
U.O. Ematologia, Piazzale Spedali Civili 1, 25123, Brescia
Azienda Ospedaliera Santa Croce E Carle
Divisione di Ematologia, Via Michele Coppino 26, 12100, Cuneo
Azienda Sanitaria Territoriale Di Ascoli Piceno
U.O.C. Ematologia-Ospedale C.e G. Mazzoni, Via Degli Iris 1, 63100, Ascoli Piceno
Azienda Sanitaria Universitaria Friuli Centrale
Clinica Ematologica- Centro Trapianti e Terapia Cellulari "Carlo Melzi", Via Pozzuolo 330, 33100, Udine
San Camillo Forlanini Hospital
U.O. Ematologia e Trapianto di Midollo Osseo, Circonvallazione Gianicolense 87, 00152, Rome
Azienda Unita Sanitaria Locale Della Romagna
Sezione di Ematologia, Via Alcide De Gasperi 8, 48121, Ravenna
Azienda Socio Sanitaria Locale N. 8 Di Cagliari
Presidio Ospedaliero Businco, Via Edward Jenner 18, 09121, Cagliari
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Oncologia Medica, Via Piero Maroncelli 40, 47014, Meldola
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Italy | 2015-01-12 | 2026-03-30 | 2015-02-19 | 2017-03-31 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 15 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_Forte version_2024_616630_35_01_V6_1_29092020_Redacted | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | D4_Patient facing documents_Neurological assessment_v1 | 1 |
| Subject information and informed consent form (for publication) | D4_Patient facing documents_QLQ-C30 e QLQ-MY20_ita_v3 | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main v9_0_20102020 | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main v9_0_20102020_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material ICF partner in gravidanza v3_0_11022019 | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material ICF partner in gravidanza v3_0_11022019_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Lettera medico curante v4_0_06082018 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Lenalidomide_30092017 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Lenalidomide_30092017 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Lenalidomide_30092017 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Lenalidomide_30092017 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Carfilzomib_19072016 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2024_616630_35_01_V4_0_11062020_Redacted | 1 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-03 | Italy | Acceptable 2025-01-13
|
2025-01-21 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-01-31 | Italy | Acceptable 2025-01-13
|
2025-01-31 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-07-14 | Italy | Acceptable | 2025-09-25 |