Multiple MyelomaPhase 3NCT02215980
STUDY TO DETERMINE THE EFFICACY AND SAFETY OF STANDARD SCHEDULE VERSUS A NEW ALGORITHM OF DOSE REDUCTIONS IN ELDERLY AND UNFIT NEWLY DIAGNOSED MULTIPLE MYELOMA PATIENTS RECEIVING LENALIDOMIDE PLUS STEROIDS
A Phase 3 study testing Lenalidomide and Dexamethasone in people with Multiple Myeloma, run by Fondazione EMN Italy Onlus at 1 site in Italy.
Trial summary
This protocol is a phase III multicenter, randomized, controlled study designed to assess the safety and the efficacy of standard schedule versus a new algoritm of dose reductions in elderly and unfit newly diagnosed Multiple Myeloma (MM) patients receiving lenalidomide plus steroids. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Lenalidomide and Dexamethasone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2014to 1 Jul 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients >65 years unfit and unsuitable, according to the investigator's opinion, to receive approved first line treatments for newly diagnosed MM.
- Patient is, in the investigator(s) opinion, willing and able to comply with the protocol requirements.
- Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
- Symptomatic MM based on standard CRAB criteria (5).
- Patient has measurable disease, defined as follows: any quantifiable serum monoclonal protein value (generally, but not necessarily, ≥ 0.5 g/dL of M-protein) and, where applicable, urine light-chain excretion of >200 mg/24 hours. For patients with oligo or non-secretory MM, it is required that they have measurable plasmacytoma > 2 cm as determined by clinical examination or applicable radiographs (i.e. MRI, CT-Scan) or an abnormal free light chain ratio (n.v.: 0.26-1.65). We anticipate that less than 10% of patients admitted to this study will be oligo- or non-secretory MM with free light chains only in order to maximize interpretation of benefit results.
- All randomized patients will be selected based on the use of 3 geriatric scales: IADL, ADL, Charlson. Unfit patients with clinical sign of frailty (mild, moderate or severe frailty), including need help for household tasks and personal care can be enrolled in this trial (2,4).
Show all 15Show fewer
- In order to include patients who normally are not select for clinical trials, also patients with the following abnormal laboratory values can be considered:
- absolute neutrophil count (ANC) < 1 x 10^9/L
- platelet count < 80 x 10^9/L
- haemoglobin < 8 g/dl.
- aspartate transaminase (AST): < 5 x the upper limit of normal (ULN).
- alanine transaminase (ALT): < 5 x the ULN.
- total bilirubin: > 1.5 x the ULN
- calculated or measured creatinine clearance: <30 mL/minute
- The geriatric assessment evaluations will select unfit patients to be randomized regardless of possible abnormal laboratory values at the study entry.
Who cannot join
- Pregnant or lactating females.
- Male patients not agreeing to use an acceptable method for contraception (i.e., condom or abstinence) for the duration of the study.
- Females of childbearing potential not agreeing to use two acceptable methods for contraception (e.g. a hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
- 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).
- Any significant medical disease or conditions that, in the investigator's opinion, may interfere with protocol adherence or subject's ability to give informed consent or could place the subject at unacceptable risk.
- Presence of clinical active infectious hepatitis type B or C, classified into Child-Pugh class C (see Appendix V) and HIV.
Show all 10Show fewer
- Presence of acute active infection requiring antibiotics or infiltrative pulmonary disease.
- Contraindication to any of the required drugs or supportive treatments.
- Presence of prior history of malignancies, other than multiple myeloma, with a life expectancy < 2 years.
- Known allergy to any of the study medications, their analogues, or excipients in the various formulations.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A PHASE III, MULTICENTRE, RANDOMIZED, CONTROLLED STUDY TO DETERMINE THE EFFICACY AND SAFETY OF STANDARD SCHEDULE VERSUS A NEW ALGORITHM OF DOSE REDUCTIONS IN ELDERLY AND UNFIT NEWLY DIAGNOSED MULTIPLE MYELOMA PATIENTS RECEIVING LENALIDOMIDE PLUS STEROIDS
This protocol is a phase III multicenter, randomized, controlled study designed to assess the safety and the efficacy of standard schedule versus a new algoritm of dose reductions in elderly and unfit newly diagnosed Multiple Myeloma (MM) patients receiving lenalidomide plus steroids.
Read the detailed description
TREATMENT PERIOD:
Arm A: Rd
- Lenalidomide: at the dose of 25 mg/daily as oral administration (PO) on days 1-21.
- Dexamethasone: at the dose of 20 mg as oral administration (PO) once weekly. Each cycle will be repeated every 28 days until progression or intolerance.
Arm B: Rd-R (reduced)
- Lenalidomide: at the dose of 25 mg/daily as oral administration (PO) on days 1-21
- Dexamethasone: at the dose of 20 mg as oral administration (PO) once weekly. Each cycle will be repeated every 28 days, for a total of 9 cycles.
Maintenance until progression or intolerance:
- Lenalidomide: 10 mg/daily on days 1-21 of each 28-day cycle
- Conditions
- Multiple Myeloma
- Being tested
- Lenalidomide, Dexamethasone
- Keywords
- Multiple myeloma, Diagnosis, Elderly and unfit patients, Lenalidomide plus steroids
- Medical subject headings
- Multiple Myeloma, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenalidomideDrug
DexamethasoneDrug
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | * Lenalidomide: at the dose of 25 mg/daily as oral administration (PO) on days 1-21.
* Dexamethasone: at the dose of 20 mg as oral administration (PO) once weekly. Each cycle will be repeated every 28 days until progression or intolerance. Receives: Drug: Lenalidomide; Drug: Dexamethasone |
| B | Experimental | * Lenalidomide: at the dose of 25 mg/daily as oral administration (PO) on days 1-21
* Dexamethasone: at the dose of 20 mg as oral administration (PO) once weekly. Each cycle will be repeated every 28 days, for a total of 9 cycles.
Maintenance until progression or intolerance:
- Lenalidomide: 10 mg/daily on days 1-21 of each 28-day cycle Receives: Drug: Lenalidomide; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free survival
Determine the Event-free survival defined as:
- Progression
- Death for any cause
- Discontinuation of lenalidomide therapy
- Occurrence of any haematological grade 4 or non-haematological grade 3-4 adverse events (AES), including Secondary Primary Malignancies (SPMs)
Measured: 3 years
Secondary outcomes (11)
Progression-free survival (PFS)
Measured: 5 years
Overall survival (OS)
Measured: 5 years
Time to progression (TTP)
Measured: 5 years
Overall response rate (ORR)
Measured: 5 years
Time to response (TTR)
Measured: 5 years
Duration of response (DOR)
Measured: 5 years
Time to the next therapy (TNT)
Measured: 5 years
Incidence of dose reduction and drug discontinuation
Measured: 5 years
Health care cost
Measured: 5 years
Correlation between tumor response and outcome with baseline prognostic factors
Analysis of tumor response and outcome stratification by prognostic factors
Measured: 5 years
Quality of life assessment (HRQOL)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2014 (estimated)
- Study startJul 2014
- Primary completionJul 2022
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione EMN Italy Onlus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02215980
- Sponsor's protocol ID
- RV-MM-PI-0752
- Status last verified
- Jul 2024
- First submitted
- 28 Jul 2014
- Last updated
- 22 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Larocca A, Bonello F, Gaidano G, D'Agostino M, Offidani M, Cascavilla N, Capra A, Benevolo G, Tosi P, Galli M, Marasca R, Giuliani N, Bernardini A, Antonioli E, Rota-Scalabrini D, Cellini C, Pompa A, Monaco F, Patriarca F, Caravita di Toritto T, Corradini P, Tacchetti P, Boccadoro M, Bringhen S. Dose/schedule-adjusted Rd-R vs continuous Rd for elderly, intermediate-fit patients with newly diagnosed multiple myeloma. Blood. 2021 Jun 3;137(22):3027-3036. doi: 10.1182/blood.2020009507.
PubMed 33739404
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE III, MULTICENTRE, RANDOMIZED, CONTROLLED STUDY TO DETERMINE THE EFFICACY AND SAFETY OF STANDARD SCHEDULE VERSUS A NEW ALGORITHM OF DOSE REDUCTIONS IN ELDERLY AND UNFIT NEWLY DIAGNOSED MULTIPLE MYELOMA PATIENTS RECEIVING LENALIDOMIDE PLUS STEROIDS
- ClinicalTrials.gov ID
- NCT02215980
- Acronym / sponsor ID
- RV-MM-PI-0752
- Conditions
- Multiple Myeloma
- Keywords
- Multiple myeloma, Diagnosis, Elderly and unfit patients, Lenalidomide plus steroids
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Fondazione EMN Italy OnlusUniversity, hospital or other
- Study start
- Jul 2014 (actual)
- Primary completion
- Jul 2022 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 13 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This protocol is a phase III multicenter, randomized, controlled study designed to assess the safety and the efficacy of standard schedule versus a new algoritm of dose reductions in elderly and unfit newly diagnosed Multiple Myeloma (MM) patients receiving lenalidomide plus steroids.
Detailed description
TREATMENT PERIOD:
Arm A: Rd
- Lenalidomide: at the dose of 25 mg/daily as oral administration (PO) on days 1-21.
- Dexamethasone: at the dose of 20 mg as oral administration (PO) once weekly. Each cycle will be repeated every 28 days until progression or intolerance.
Arm B: Rd-R (reduced)
- Lenalidomide: at the dose of 25 mg/daily as oral administration (PO) on days 1-21
- Dexamethasone: at the dose of 20 mg as oral administration (PO) once weekly. Each cycle will be repeated every 28 days, for a total of 9 cycles.
Maintenance until progression or intolerance:
- Lenalidomide: 10 mg/daily on days 1-21 of each 28-day cycle
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Lenalidomide, Drug: Dexamethasone* Lenalidomide: at the dose of 25 mg/daily as oral administration (PO) on days 1-21. * Dexamethasone: at the dose of 20 mg as oral administration (PO) once weekly. Each cycle will be repeated every 28 days until progression or intolerance. |
| B | Experimental | Drug: Lenalidomide, Drug: Dexamethasone* Lenalidomide: at the dose of 25 mg/daily as oral administration (PO) on days 1-21 * Dexamethasone: at the dose of 20 mg as oral administration (PO) once weekly. Each cycle will be repeated every 28 days, for a total of 9 cycles. Maintenance until progression or intolerance: - Lenalidomide: 10 mg/daily on days 1-21 of each 28-day cycle |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (15 listed)
- Patients >65 years unfit and unsuitable, according to the investigator's opinion, to receive approved first line treatments for newly diagnosed MM.
- Patient is, in the investigator(s) opinion, willing and able to comply with the protocol requirements.
- Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
- Symptomatic MM based on standard CRAB criteria (5).
- Patient has measurable disease, defined as follows: any quantifiable serum monoclonal protein value (generally, but not necessarily, ≥ 0.5 g/dL of M-protein) and, where applicable, urine light-chain excretion of >200 mg/24 hours. For patients with oligo or non-secretory MM, it is required that they have measurable plasmacytoma > 2 cm as determined by clinical examination or applicable radiographs (i.e. MRI, CT-Scan) or an abnormal free light chain ratio (n.v.: 0.26-1.65). We anticipate that less than 10% of patients admitted to this study will be oligo- or non-secretory MM with free light chains only in order to maximize interpretation of benefit results.
Key exclusion criteria (10 listed)
- Pregnant or lactating females.
- Male patients not agreeing to use an acceptable method for contraception (i.e., condom or abstinence) for the duration of the study.
- Females of childbearing potential not agreeing to use two acceptable methods for contraception (e.g. a hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
- 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).
- Any significant medical disease or conditions that, in the investigator's opinion, may interfere with protocol adherence or subject's ability to give informed consent or could place the subject at unacceptable risk.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lenalidomide | Drug | A, B |
| Dexamethasone | Drug | A, B |
Primary outcome
Event-free survival
Time frame: 3 years
Determine the Event-free survival defined as: * Progression * Death for any cause * Discontinuation of lenalidomide therapy * Occurrence of any haematological grade 4 or non-haematological grade 3-4 adverse events (AES), including Secondary Primary Malignancies (SPMs)
11 secondary outcomes
Progression-free survival (PFS)
Time frame: 5 years
Overall survival (OS)
Time frame: 5 years
Time to progression (TTP)
Time frame: 5 years
Overall response rate (ORR)
Time frame: 5 years
Time to response (TTR)
Time frame: 5 years
Duration of response (DOR)
Time frame: 5 years
Time to the next therapy (TNT)
Time frame: 5 years
Incidence of dose reduction and drug discontinuation
Time frame: 5 years
Health care cost
Time frame: 5 years
Correlation between tumor response and outcome with baseline prognostic factors
Time frame: 5 years
Quality of life assessment (HRQOL)
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
- Derived from this study: PubMed 33739404Larocca A, Bonello F, Gaidano G, D'Agostino M, Offidani M, Cascavilla N, Capra A, Benevolo G, Tosi P, Galli M, Marasca R, Giuliani N, Bernardini A, Antonioli E, Rota-Scalabrini D, Cellini C, Pompa A, Monaco F, Patriarca F, Caravita di Toritto T, Corradini P, Tacchetti P, Boccadoro M, Bringhen S. Dose/schedule-adjusted Rd-R vs continuous Rd for elderly, intermediate-fit patients with newly diagnosed multiple myeloma. Blood. 2021 Jun 3;137(22):3027-3036. doi: 10.1182/blood.2020009507.
Related trials for Multiple Myeloma
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lenalidomide and Dexamethasone in people with Multiple Myeloma, run by Fondazione EMN Italy Onlus at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event-free survival (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02215980, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2024.