A Phase 3 interventional study of Melphalan, Prednisone, Lenalidomide and Cyclophosphamide, Prednisone, Lenalidomide in Multiple Myeloma, sponsored by Fondazione EMN Italy Onlus. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-07.
Sponsored by Fondazione EMN Italy Onlus · Phase 3, Interventional, and Treatment
This is a multicenter, randomized, controlled, 3 arm parallel group study designed to evaluate the efficacy and safety of three all-oral combinations: lenalidomide with dexamethasone (Rd) in comparison with lenalidomide in association with MP (MPR) and lenalidomide in association with cyclophosphamide - prednisone (CPR) in newly diagnosed symptomatic MM patients. This protocol also provides a substudy designed to observe asymptomatic patients excluded to the protocol that in any case could be inserted in the study.
This is an intergroup multicenter, randomized, open label study designed to compare the efficacy and safety of Rd with MPR and CPR in newly diagnosed symptomatic MM patients who are 65 years of age or older. Potential study subjects will sign an informed consent prior to undergoing any study related procedure.
This study consists of 3 phases for each study subject: Pre-treatment, Treatment and Follow up.Pre-treatment period: patients will undergo screening for protocol eligibility within 28 days (4weeks) prior to randomization.
Subjects who meet all the inclusion criteria will be randomized based on a computer-generated randomization schedule prepared by the Coordinating Centre. The first randomization will occur for the induction treatment: Arm A (Rd) or B (MPR) or C (CPR). Within each arm patients will be then randomized for the maintenance treatment(lenalidomide or lenalidomide and prednisone): Arms A1 (R) and A2 (RP); Arms B1 (R) and B2 (RP); Arms C1 (R) and C2 (RP). Randomization will be concealed until the end of the induction period for the maintenance treatment. Patients will be stratified at randomization according to the International Staging System (5) and age (\< 75 years vs > 75 years).Treatment period includes induction and maintenance. During the induction and maintenance phases, all patients will attend periodic study center visits in order to asses the safety and efficacy of the treatment. This protocol also provides a substudy designed to observe asymptomatic patients excluded to the protocol that in any case could be inserted in the study . The asymptomatic patient is characterized by the absence of end-organ damage or tissue involvement, such as anemia, bone lesions, hypercalcemia, and renal failure, or by other relevant clinical conditions, such as hyperviscosity, amyloidosis, and recurrent infections (CRAB).
3,760 studies on the registry are indexed under Multiple Myeloma; 769 are open to participants now.
This study's enrollment of 660 is above the median of 41 across 3,005 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Fondazione EMN Italy Onlus is the lead sponsor of 21 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Female patient is either or surgically sterilized or, if at †, must:
Combined oral contraceptive pills are not recommended. If a subject was using combined oral contraception, she must switch to one of the methods above. The increased risk of VTE continues for 4 to 6 weeks after stopping combined oral contraception.
prophylactic antibiotics should be considered at the time of insertion particularly in patients with neutropenia due to risk of infection
Agree to have a medically supervised pregnancy test every 4 weeks including 4 weeks after the end of study treatment, except in the case of confirmed tubal sterilization. These tests should be performed not more than 3 days before the start of next treatment. This requirement also applies to women of childbearing potential who practice complete and continued abstinence
Agree not to donate semen during study drug therapy and for one week after end of study drug therapy.
Agree not to share study medication with another person and to return all unused study drug to the investigator.
Non-secretory myeloma: > 30% plasma cells in the bone marrow and at least one plasmacytoma > 2 cm as determined by clinical examination or applicable radiographs (i.e., MRI or CT scan).
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Induction treatment with oral Lenalidomide and low dose dexamethasone followed by maintenance therapy with Lenalidomide alone or Lenalidomide and Prednisone
Drug: Lenalidomide, dexamethasone
Induction treatment with oral Lenalidomide, Prednisone and Melphalan followed by maintenance therapy with Lenalidomide alone or Lenalidomide and Prednisone
Drug: Melphalan, Prednisone, Lenalidomide
Induction treatment with oral Lenalidomide, Cyclophosphamide and Prednisone for followed by maintenance therapy with Lenalidomide alone or Lenalidomide and Prednisone.
Drug: Cyclophosphamide, Prednisone, Lenalidomide
Drug pages: Melphalan · Prednisone · Lenalidomide
Induction: 9 courses every 28 days - oral Lenalidomide for 21 days followed by a 7 days rest period; oral Melphalan for 4 days, followed by a 24 days rest period \[different doses according to the age of patients (65-75 or \>75 years old);oral Prednisone for 4 days followed by a 24 day rest period. Maintenance: ARM A1, B1 and C1 - oral Lenalidomide on day 1-21 followed by a 7 days rest period. ARM A2,B2 and C2:oral Lenalidomide on day 1-21 followed by a 7 days rest period and oral Prednisone every other day.Each cycle will be repeated every 28 days, until any sign of disease progression(PD).
Drug pages: Cyclophosphamide · Prednisone · Lenalidomide
Induction: 9 cycles every 28 days:Lenalidomide will be given orally at the dose of 25 mg/day for 21 days followed by a 7 days rest period (day 22 to 28;Cyclophosphamide will be given orally at the dose of 50 mg /day for 21 days followed by a 7 day rest period (days 1 to 28) in patients 65-75 years old and 50 mg every other day (days 1 to 20 followed by a 8 days rest period \[day 21 to 28\]) in patients older than 75 years.Prednisone will be given orally at the dose of 25 mg every other day (days 1 to 28.Each cycle will be repeated every 28 days, until any sign of disease progression(PD).
Drug pages: Lenalidomide · Dexamethasone
Induction: 9 course every 28 days-Lenalidomide will be given orally at the dose of 25 mg/day for 21 days followed by a 7 days rest period (day 22 to 28); Dexamethasone will be given orally at the dose of 40 mg on days 1, 8, 15 and 22 every 28 days in patients 65-75 years old and at the dose of 20 mg on days 1,8,15 and 22 every 28 days in patients older than 75 years. Maintenance:After 2-3 months from the completion of the last induction cycle, patients will start maintenance therapy according to physician willing and general dose-reduction rules.ARM A1, B1 and C1:Lenalidomide will be given at the dose of 10 mg/day on day 1-21 followed by a 7 days rest period. ARM A2, B2 and C2:Lenalidomide will be given at the dose of 10 mg/day on day 1-21 followed by a 7 days rest period; Prednisone will be given orally at the dose of 25 mg every other day (days 1 to 28) Each cycle will be repeated every 28 days, until any sign of disease progression (PD).
Progression Free Survival
Time frame: 5 years
Overall Survival
Time frame: 5 years
Overall Response Rate
Time frame: 5 years
Time to progression
Time frame: 5 years
Time and duration of response
Time frame: 5 years
Time to next therapy
Time frame: 5 years
Grade 3-4 hematological and non-hematological adverse events (AEs)
Time frame: 5 years
Prognosis and cytogenetic abnormalities
Time frame: 5 years
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Melphalan · Prednisone · Lenalidomide · Cyclophosphamide
Fondazione EMN Italy Onlus