Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruitment ended
Participants planned
450
Countries
1
Sites
32
Newly diagnosed MM patients >= 65 years old or ineligible for autologous stem cell transplant
The primary objective is to compare the progression-free survival (PFS) of bortezomib-melphalan-prednisone (VMP) vs lenalidomide-dexamethasone (Rd) treatments with or without daratumumab (Dara-VMP, Dara-Rd) in real life unselected patient population.
Key facts
- Sponsor
- Universita' Degli Studi Di Torino
- Participant type
- Patients
- Age range
- 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 5 Sep 2018 → ongoing
- Decision date (initial)
- 2024-08-07
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- AIFA
External identifiers
- EU CT number
- 2024-512049-17-00
- EudraCT number
- 2017-004003-46
- ClinicalTrials.gov
- NCT03829371
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Therapy, Efficacy
The primary objective is to compare the progression-free survival (PFS) of bortezomib-melphalan-prednisone (VMP) vs lenalidomide-dexamethasone (Rd) treatments with or without daratumumab (Dara-VMP, Dara-Rd) in real life unselected patient population.
Secondary objectives 15
- To compare the overall response rate (ORR) between the VMP and Rd arms with or without daratumumab (Dara-VMP vs Dara-Rd, VMP vs Rd )
- To determine the minimal residual disease (MRD) negativity rate by NGF of DARA-VMP (A2) arm and DARA-Rd (B2) arm at 6th, 12th, 24th, 36th, 48th, 60th months
- To compare the duration of response (DOR) between the VMP and Rd arms with or without daratumumab (Dara-VMP vs Dara-Rd, VMP vs Rd)
- To compare the overall survival (OS) between the VMP and Rd arms with or without daratumumab (Dara-VMP vs Dara-Rd, VMP vs Rd)
- To compare the progression-free survival 2 (PFS2) between the VMP and Rd arms with or without daratumumab (Dara-VMP vs Dara-Rd, VMP vs Rd)
- To compare the time to next therapy (TNT) between the VMP and Rd arms with or without daratumumab (Dara-VMP vs Dara-Rd, VMP vs Rd)
- To compare the time to progression (TTP) between the VMP and Rd arms with or without daratumumab (Dara-VMP vs Dara-Rd, VMP vs Rd)
- To compare safety in terms of incidence of hematologic and non-hematologic adverse events between the VMP and Rd arms with or without daratumumab (Dara-VMP vs Dara-Rd, VMP vs Rd)
- To compare the rate of treatment discontinuation and dose reductions or death for toxicity between the VMP and Rd arms with or without daratumumab (Dara-VMP vs Dara-Rd, VMP vs Rd)
- To validate the frailty score in a real-life population, using geriatric assessment and considering patients’ non-Myeloma polydrug therapies
- To compare the Quality of Life (QoL) between the VMP and Rd arms with or without daratumumab (Dara-VMP vs Dara-Rd, VMP vs Rd)
- To compare direct health related costs and indirect costs between the VMP and Rd arms with or without daratumumab (Dara-VMP vs Dara-Rd, VMP vs Rd)
- To evaluate the risk of infectious complications between VMP and Rd arms with or without daratumumab (Dara-VMP vs Dara-Rd, VMP vs Rd)
- To determine the correlation between MRD negativity and PFS, PFS2, TTP, TNT, and OS
- To determine difference of response and outcome in subgroups with different prognostic factors
Conditions and MedDRA coding
Newly diagnosed MM patients >= 65 years old or ineligible for autologous stem cell 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 | Treatment All patients will be randomized in a 1:1 ratio to receive a standard treatment: daratumumab, bortezomib in combination with melphalan and prednisone (DARA-VMP– ArmA2) or the association of daratumumab, lenalidomide and dexamethasone (DARA-Rd– Arm B2).
Patients will be stratified according to frailty score (3 levels) and cytogenetic FISH results (2 levels) and then randomized using an unblinded web-based, computer generated, procedure completely concealed to study participants. Randomization will be performed according to a randomization list provided by statisticians.
The duration of treatment will depend on condition of patient and disease.
Each patient will be evaluated at diagnosis with standard prognostic tests, and with a geriatric assessment (GA). The treatment will be provided according to technical data sheet.
The duration of the study is approximately 10 years. In particular, a first report with available results will be provided 1 year after enrollment completion. The AE and SAE will be collected until 30th day from the last dose administration. Patients will be followed for 5 years; survival data will be collected until death.
|
Randomised Controlled | None | ArmA2: - Bortezomib (V): 1. 3 mg/m2 subcutaneously twice weekly on weeks 1, 2, 4, and 5 of cycle 1 and once weekly on weeks 1, 2, 4, and 5 of cycles 2 through 9. - Melphalan (M): 9 mg/m2 orally on days 1, 2, 3 and 4 of each cycle. - Prednisone (P):60 mg/m2 orally on days 1, 2, 3 and 4 of each cycle. Maximum 9 cycles of VMP can be performed. - Daratumumab (Dara) 16 mg per kilogram of body weight or 1800 mg Daratumumab subcutaneous (SC) (according to local clinical practice) with oral or intravenous dexamethasone (to manage infusion reactions) at a dose of 20 mg once weekly in cycle 1, every 3 weeks in cycles 2 through 9, and every 4 weeks thereafter until disease progression or unacceptable toxic effects. Dexamethasone at a dose of 20 mg was substituted for prednisone on day 1 of each cycle. ArmB2: - LenaIomide (R) 25 mg orally on days 1-21 of each cycle. - Dexamethasone (d) 40 mg orally on days 1, 8, 15 and 22 of each cycle. Each cycle is a 28-day cycles. - Daratumumab (Dara) intravenous at a dose of 16 mg per kilogram of body weight or 1800 mg Daratumumab subcutaneous (SC) (according to local clinical practice) once weekly during cycles 1 and 2, every 2 weeks during cycles 3 through 6, and every 4 weeks thereafter; preinfusion medications were administered approximately 1 hour before each daratumumab dose. ArmA (enrolment closed): -Bortezomib (V) * 1.3 mg/m2 subcutaneously on days 1, 4, 8, 11, 22, 25, 29 and 32 in cycles 1-4; * 1.3 mg/m2 subcutaneously on days 1, 8, 22 and 29 in cycles 5-9. - Melphalan (M) 9 mg/m2 orally on days 1, 2, 3 and 4 of each cycle. - Prednisone (P) 60 mg/m2 orally on days 1, 2, 3 and 4 of each cycle. Each cycle is to be repeated every 42 days. Treatment will last maximum 9 cycles, except in case of toxicity or early interruption for any cause. After 9 cycles of therapy, patients will be observed until progression disease or the start of a new line of therapy. ArmB (enrolment closed): - Lenalidomide (R) 25 mg orally on days 1-21 of each cycle. - Dexamethasone (d) 40 mg orally on days 1, 8, 15 and 22 of each cycle. Each cycle is a 28-day cycles. Patients will receive treatment until disease progression, any unacceptable toxicity or according to physicians’ opinion. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 16
- Patients has given voluntary written informed consent before the performance of any study related procedure
- Patients with newly diagnosed symptomatic multiple myeloma (NDMM) based on standard IMWG (International Myeloma Working Group) criteria:
- 1) Clonal bone marrow plasma cells ≥10% or biopsy-proven bony or extramedullary plasmacytoma and any one or more of the following CRAB features and myeloma-defining events:
- 1.1) Evidence of end organ damage that can be attributed to the underlying plasma cell proliferative disorder, specifically
- 1.1.1) Hypercalcemia: serum calcium >0.25 mmol/L (>1mg/dL) higher than the upper limit of normal or >2.75 mmol/L (>11mg/dL)
- 1.1.2) Renal insufficiency: creatinine clearance (CLcr)<40 mL per minute (measured or estimated by validated equations) or serum creatinine > 177 µmol/L (>2mg/dL)
- 1.1.3) Anemia: hemoglobin value of >20g/L below the lower limit of normal, or a hemoglobin value <100g/L
- 1.1.4) Bone lesions: one or more osteolytic lesion on skeletal radiography, CT, or PET/CT. If bone marrow has <10% clonal plasma cells, more than one bone lesion is required to distinguish from solitary plasmacytoma with minimal marrow involvement
- 1.2) Any one or more of the following biomarkers of malignancy:
- 1.2.1) Clonal bone marrow plasma cell percentage ≥60% (clonality should be established by showing κ/λ-light-chain restriction on flow cytometry, immunohistochemistry, or immunofluorescence. Bone marrow plasma cell percentage should preferably be estimated from a core biopsy specimen; in case of a disparity between the aspirate and core biopsy, the highest value should be used)
- 1.2.2) Involved/uninvolved serum free light chain ratio ≥100 (values based on the serum Freelite assay. The involved free light chain must be ≥100 mg/L)
- 1.2.3) >1 focal lesion detected by MRI (magnetic resonance imaging) studies (each focal lesion must be 5 mm or more in size
- According to physician’s opinion, patients can undergo either one of the two standard treatments and procedures
- Females of childbearing potential (FBCP) must use an effective contraceptive method for 28 days before the study treatment, during the treatment and for at least 3 months after the last dose of study drugs
- Male subjects must use an effective barrier method if sexually active with FCBP during treatment and for at least 6 months after the last dose of study drug
- Patients should be ineligible for ASCT, defined as: - ≥ 65 years old; - younger than 65 years but who reject the transplant procedure or with abnormal cardiac, pulmonary, hepatic and renal function defined as: • LVEF (left ventricular ejection fraction) < 40%; • FEV1 (forced expiratory volume-1 second) < 40%; • Bilirubin > 1.5 UNL, AST/ALT >2.5 UNL; • Creatinine clearance < 60 mL/min.
Exclusion criteria 10
- Hypersensitivity to any active substance or to any of the excipients (lactose, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, boron, mannitol, nitrogen, crospovidone, colloidal anhydrous silica, hypromellose, titanium dioxide, macrogol, talc, sodium starch glycolate, sodium benzoate, propylene glycol, sodium dihydrogen phosphate, hydroxypropyl beta cyclodextrin, sodium saccharin, sodium EDTA, sodium hydroxide, L-histidine, L-histidine hydrochloride monohydrate, L-methionine, polysorbate 20, sorbitol (E420), recombinant human hyaluronidase (rHuPH20))
- Hereditary intolerance to fructose
- Pregnant and lactating women
- FBCP that do not follow the Pregnancy Prevention Plan requirements
- Acute diffuse infiltrative pulmonary and pericardial disease
- Acute viral infections (e.g. herpes simplex or ocular herpes simplex, herpes zoster, varicella)
- Systemic mycotic or bacterial infections, unless specific anti-infectious therapy is ongoing
- Peptic ulcer
- Psychosis
- Administration of prophylactic vaccine from 8 to 2 weeks before starting treatment
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- PFS will be measured from the date of randomization to the date of first observation of PD, or death from any cause as an event. Subjects who withdraw from the study will be censored at the time of the last complete disease assessment. Subjects who complete the study, have not progressed, and are still alive at the cut-off date of final analysis will be censored at the cut-off date. All subjects who were lost to FU will also be censored at the time of last contact.
Secondary endpoints 13
- The rate of MRD negativity at 6 months after the start of treatment is determined as the proportion of patients with MRD negativity (≥10-5 sensitivity level) at 6 months using ITT principle. For patients who withdraw from the study or are lost to follow up before these timepoints, the best MRD assessment will be considered.
- The rate of MRD negativity is determined as the proportion of patients with MRD negativity by Next Generation Flow (≥10-5 sensitivity level) at 6, 12, 24-, 36-, 48- and 60-months using ITT principle. For patients who withdraw from the study or are lost to follow up before 6, 12, 24, 36, 48 and 60 months, the best MRD assessment will be considered. Patients will be classified as MRD positive if they have only MRD positive test results or do not undergo MRD assessment.
- ORR will include complete response (CR) and partial response (PR) using the International Response Criteria reported by Durie et al. Categories of response will include stringent CR (sCR), CR, very good partial response (VGPR), PR and PD. If, during the course of the study, other relevant categories are identified in literature, such new categories may be added. Responders are defined as subjects with at least a PR.
- DOR is defined as time between first documentation of response and PD. Responders without disease progression will be censored either at the time of lost to FU, at the time of death due to other cause than PD, or at the end of the study.
- PFS2 is defined as the time from randomization to objective tumor progression on next-line treatment or death from any cause.
- OS is defined as the time between randomization and death. Subjects who die will be censored at time of death as an event, regardless cause of death. Subjects who withdraw consent will be censored at the time of withdrawal. Subjects who complete the study and are still alive at the cut-off date of final analysis will be censored at the cut-off date. Subjects lost to FU will also be censored at the time of last contact.
- TNT will be measured from the date of randomization to the date of next anti-myeloma therapy. Death due to any cause before starting therapy will be considered an event. Subjects who withdraw consent will be censored at the time of the last complete disease assessment. Subjects who complete the study and are still alive at the cut-off date of final analysis will be censored at the cut-off date. Subjects lost to FU will also be censored at the time of last contact.
- TTP will be measured from the date of randomization to the date of first observation of PD, or deaths related to PD. Subjects who withdraw from the study or die from causes other than PD will be censored at the time of the last complete disease assessment. Subjects who complete the study, have not progressed, and are still alive at the cut-off date of final analysis will be censored at the cut-off date. Subjects lost to FU will also be censored at the time of last contact.
- Safety will be evaluated by assessing the incidence, severity and type of AEs according to NCI-CTCAE v. 4.0. and the incidence of toxicities as well as the rate of treatment discontinuation or death for toxicity will be evaluated during the entire duration of the trial.
- Validation of frailty score will be made by estimating efficacy and safety endpoints in patients stratified according to Myeloma Frailty Score and by considering patients’ non-Myeloma polydrug therapies.
- QoL will be evaluated through Health-Related QoL (HRQoL) questionnaires: EORTC-QLQ-C30 (a generic, multidimensional, cancer-specific QoL questionnaire), QLQ-MY20 (a specific 20- item MM module) and EQ-5D-5L (a generic assessment of five health categories and overall health score). After baseline visit, questionnaires should be collected every 3 months for the first year and every 6 months thereafter.
- Health-related costs will be reported through questionnaires. Every 3 months for the first year and every 6 months thereafter, patients or care-givers will be asked to fill out self-reported questionnaire regarding outpatient and GPs visits, emergency care, in-patient stays, home care, nursing home or residential care, care-giving, and personal use and expenditure for health related services.
- Infectious risk complications will be evaluated in terms of incidence, severity, type of infection, need for hospitalization, deferral or suspension of study treatment with possible impact on PFS.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 14
VELCADE 3.5 mg powder for solution for injection
PRD3349073 · Product
- Active substance
- Bortezomib
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 1.3 mg/m2 milligram(s)/sq. meter
- Max total dose
- 67.6 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 54 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XG01 — -
- Marketing authorisation
- EU/1/04/274/001
- MA holder
- JANSSEN-CILAG INTERNATIONAL NV
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD9264285 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 24150 mg milligram(s)
- Max treatment duration
- 46 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/07/391/007
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD9264283 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 24150 mg milligram(s)
- Max treatment duration
- 46 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
PRD9264267 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 24150 mg milligram(s)
- Max treatment duration
- 46 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/07/391/009
- 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
- 25 mg milligram(s)
- Max total dose
- 24150 mg milligram(s)
- Max treatment duration
- 46 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
PRD9264271 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 24150 mg milligram(s)
- Max treatment duration
- 46 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
PRD9264282 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 24150 mg milligram(s)
- Max treatment duration
- 46 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/07/391/003
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
DARZALEX 1800 mg solution for injection
PRD8157846 · Product
- Active substance
- Daratumumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 1800 mg milligram(s)
- Max total dose
- 140400 mg milligram(s)
- Max treatment duration
- 70 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01FC01 — -
- Marketing authorisation
- EU/1/16/1101/004
- MA holder
- JANSSEN-CILAG INTERNATIONAL NV
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/13/1153
- Modified vs. Marketing Authorisation
- No
DARZALEX 20 mg/mL concentrate for solution for infusion
PRD4091129 · Product
- Active substance
- Daratumumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 16 mg/kg milligram(s)/kilogram
- Max total dose
- 1248 mg/kg milligram(s)/kilogram
- Max treatment duration
- 70 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01FC01 — -
- Marketing authorisation
- EU/1/16/1101/001
- MA holder
- JANSSEN-CILAG INTERNATIONAL NV
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/13/1153
- Modified vs. Marketing Authorisation
- No
DARZALEX 20 mg/mL concentrate for solution for infusion
PRD4091122 · Product
- Active substance
- Daratumumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 16 mg/kg milligram(s)/kilogram
- Max total dose
- 1248 mg/kg milligram(s)/kilogram
- Max treatment duration
- 70 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01FC01 — -
- Marketing authorisation
- EU/1/16/1101/002
- MA holder
- JANSSEN-CILAG INTERNATIONAL NV
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/13/1153
- Modified vs. Marketing Authorisation
- No
DARZALEX 20 mg/mL concentrate for solution for infusion
PRD6808129 · Product
- Active substance
- Daratumumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 16 mg/kg milligram(s)/kilogram
- Max total dose
- 1248 mg/kg milligram(s)/kilogram
- Max treatment duration
- 70 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01FC01 — -
- Marketing authorisation
- EU/1/16/1101/003
- MA holder
- JANSSEN-CILAG INTERNATIONAL NV
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/13/1153
- Modified vs. Marketing Authorisation
- No
Prednisone Teva 5 mg compresse
PRD4140796 · Product
- Active substance
- Prednisone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 60 mg/m2 milligram(s)/sq. meter
- Max total dose
- 2160 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 54 Week(s)
- Authorisation status
- Authorised
- ATC code
- H02AB — GLUCOCORTICOIDS
- Marketing authorisation
- 043411026
- MA holder
- TEVA ITALIA S.R.L.
- MA country
- Italy
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
ALKERAN 2 mg Compresse rivestite con film
PRD981238 · Product
- Active substance
- Melphalan
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 9 mg/m2 milligram(s)/sq. meter
- Max total dose
- 324 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 54 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01AA03 — MELPHALAN
- Marketing authorisation
- 021250030
- MA holder
- ASPEN PHARMA TRADING LIMITED
- MA country
- Italy
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SOLDESAM 0,2% gocce orali, soluzione
PRD362173 · Product
- Active substance
- Dexamethasone Sodium Phosphate
- Pharmaceutical form
- ORAL DROPS, SOLUTION
- Route of administration
- ORAL USE
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 7360 mg milligram(s)
- Max treatment duration
- 46 Month(s)
- Authorisation status
- Authorised
- ATC code
- H02AB02 — DEXAMETHASONE
- Marketing authorisation
- 019499072
- MA holder
- LABORATORIO FARMACOLOGICO MILANESE S.R.L.
- MA country
- Italy
- 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 Cherasco 15
- City
- Turin
- Postcode
- 10126
- Country
- Italy
Scientific contact point
- Organisation
- Universita' Degli Studi Di Torino
- Contact name
- Alessandra Larocca
Public contact point
- Organisation
- Universita' Degli Studi Di Torino
- Contact name
- Francesco Novelli
Third parties 6
| Organisation | City, country | Duties |
|---|---|---|
| Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico ORG-100010060
|
Bologna, Italy | Laboratory analysis |
| Mipharm S.p.A. ORG-100000724
|
Milan, Italy | Other |
| Universita' Degli Studi Di Torino ORG-100008619
|
Turin, Italy | Laboratory analysis |
| IRCCS Centro Di Riferimento Oncologico Della Basilicata ORG-100048195
|
Rionero In Vulture, Italy | Laboratory analysis |
| Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco Di Catania ORG-100009880
|
Catania, Italy | Laboratory analysis |
| Azienda Ospedaliero Universitaria Parma ORG-100007024
|
Parma, Italy | Laboratory analysis |
Locations
1 EU/EEA country · 32 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ongoing, recruitment ended | 450 | 32 |
| Rest of world | — | 0 | — |
Investigational sites
Ospedale San Raffaele S.r.l.
U.O. Ematologia e TMO, Via Olgettina 60, 20132, Milan
Azienda Ospedaliero Universitaria Parma
Sezione di ematologia e CTMO, Viale Antonio Gramsci 14, 43126, Parma
Azienda Ospedaliera Universitaria Gaetano Martino Messina
U.O.C Ematologia, Via Consolare Valeria N 1, 98124, Messina
Fondazione IRCCS San Gerardo Dei Tintori
Dipartimento di Ematologia, Via Giovanni Battista Pergolesi 33, 20900, Monza
Careggi University Hospital
SODc Ematologia, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Ematologia, Viale Del Policlinico 155, 00161, Rome
Azienda Ospedaliera di Padova
Ematologia-Immunologia Clinica, Via Nicolo' Giustiniani 2, 35128, Padova
Azienda Sanitaria Universitaria Friuli Centrale
SOC Clinica Ematologica, Piazzale Santa Maria Della Misericordia 15, 33100, Udine
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Reparto di Ematologia, Via Piero Maroncelli 40, 47014, Meldola
Grande Ospedale Metropolitano Bianchi Melacrino Morelli
Ematologia, Via Giuseppe Melacrino 21, 89124, Reggio Calabria
Azienda Ospedaliera Papardo
Ematologia, Viale Ferdinando Stagno D'alcontres Contrada Papardo, 98158, Messina
Centro Di Riferimento Oncologico Di Aviano
Oncoematologia, trapianti emopoietici e terapie cellulari, Via Franco Gallini 2, 33081, Aviano
Azienda Ospedaliera Santa Croce E Carle
S.C Ematologia, Via Michele Coppino 26, 12100, Cuneo
Azienda Ospedaliero-Universitaria Maggiore Della Carita
Divisione di Ematologia, Corso Giuseppe Mazzini 18, 28100, Novara
Azienda Ulss 6 Euganea
Ematologia, Via Enrico Degli Scrovegni 14, 35131, Padova
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Dipartimento malattie oncologiche ed ematologiche, Via Pietro Albertoni 15, 40138, Bologna
Azienda Unita Sanitaria Locale Della Romagna
U.O. Ematologia, Viale Luigi Settembrini 2, 47923, Rimini
University Hospital Consorziale Policlinico
U.O.C. Medicina Interna Universitaria ''G. Baccelli'', Piazzale Giulio Cesare 11, 70124, Bari
Fondazione IRCCS Policlinico San Matteo
Ematologia, Viale Camillo Golgi 19, 27100, Pavia
Azienda Sanitaria Locale Della Provincia Di Biella
S.S.D. Ematologia, Via Dei Ponderanesi 2, 13875, Ponderano
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
S.C. Ematologia, Corso Bramante 88, 10126, Turin
ASST Grande Ospedale Metropolitano Niguarda
Dipartimento Ematologia, Oncologia e Medicina Molecolare, Piazza Dell'ospedale Maggiore 3, 20162, Milan
Azienda Sanitaria Locale Di Pescara
U.O.C Ematologia, Via Renato Paolini 47, 65124, Pescara
Azienda Ospedaliera S Maria Di Terni
S.C.Oncoematologia, Viale Tristano Di Joannuccio 1, 05100, Terni
Azienda Ospedaliera Policlinico Universitario Tor Vergata
U.O.C. Patologie Linfoproliferative, Viale Oxford 81, 00133, Rome
Azienda Ospedaliero Universitaria Di Modena
Oncologia ed Ematologia, Largo Del Pozzo 71, 41124, Modena
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Ematologia, Piazzale Spedali Civili 1, 25123, Brescia
Ospedale Generale Provinciale Di Macerata
Ematologia, Via Santa Lucia 2, 62100, Macerata
ARNAS G. Brotzu
U.O. Ematologia-CTMO, Piazzale Alessandro Ricchi 1, 09121, Cagliari
Azienda Ospedaliero Universitaria Delle Marche
Clinica di Ematologia, Via Conca 71, 60126, Ancona
University Hospital Consorziale Policlinico
U.O. di Ematologia con Trapianto, Piazzale Giulio Cesare 11, 70124, Bari
Casa Sollievo Della Sofferenza
U.O. Ematologia, Viale Convento Cappuccini 1, 71013, San Giovanni Rotondo
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 | 2018-09-05 | 2018-12-14 | 2025-07-07 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 25 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024_512049_17 v2_0_18102021_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_REAL MM_2024 512049 17 00_Note to File NA | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main v2_0_18102021_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Addendum ICF v1_0_02012023 | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Foglio assunzione farmaco_Braccio RD v1_1_03082018 | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Foglio assunzione farmaco_Braccio VMP v1_1_03082018 | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material HCP_Checklist_Revlimid_2017 | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material ICF partner in gravidanza v2_0_18102021_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Lettera medico curante v2_0_18102021 | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Manuale_Op Sanitari_Revlimid_2017_copertina | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Manuale_Op Sanitari_Revlimid_2017_interno | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Manuale_Paziente_Revlimid_2017 | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Modulo_Gravidanza_Revlimid_2017 | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Questionari ADL IADL v1_0_19122017 | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Questionari costi paziente v1_0_19122017 | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Questionari QLQ-C30 QLQ-MY20 v1_0_19122017 | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Questionario EQ-5D-5L v1_0_19122017 | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Scheda_Paziente_Revlimid_2017 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Daratumumab_16072021 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Dexamethasone_25072017 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Lenalidomide_30092017 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Melphalan_10062016 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Prednisone_25052018 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Velcade_21022018 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis IT 2024_512049_17 v2_0_18102021_Redacted | 2.0 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-12 | Italy | Acceptable 2024-08-02
|
2024-08-07 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-10-16 | Italy | Acceptable | 2024-11-26 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-01-27 | Italy | Acceptable | 2025-01-27 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-12-05 | Italy | Acceptable | 2025-12-05 |