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Multiple MyelomaPhase 2IFM2012-03NCT02302495

Study of Carfilzomib Weekly Plus Melphalan and Prednisone in Untreated Symptomatic Elderly Multiple Myeloma

A Phase 2 study testing Carfilzomib in people with Multiple Myeloma, run by University Hospital, Lille at 33 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

IFM 2012-03 protocol is a Phase 2 multicenter nonrandomized open in elderly patients with multiple myeloma at diagnosis. Study primary objectives are in the first step to determine Maximum tolerated dose (MTD) of Carfilzomib Weekly based on definition of Dose-limiting toxicities (DLTs) and in the second step to… 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?
Carfilzomib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
33 sitesFrance
Study dates
8 Jan 2014to 31 Jul 2021
Phase
Phase 2
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

  • able to understand and voluntarily sign an informed consent form
  • able to adhere to the study visit schedule and other protocol requirements.
  • age ≥ 65 years.
  • life expectancy > 6 months.Patients must have Symptomatic Measurable previously Untreated MM
  • have measurable disease as defined by the following: quantifiable monoclonal M-component value in the serum and/or urine
  • eastern Cooperative Oncology Group performance status score ≤2
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  • dequate bone marrow function, documented within 72 hours and without transfusion 5 days prior to the first intake of investigational product no growth factor support Adequate organ function
  • subjects affiliated with an appropriate social security system.
  • male subjects must:Understand the potential teratogenic,and genotoxic risk of Melphalan if engaged in sexual activity with a pregnant female or a female of childbearing potential.
  • understand the potential genotoxic risk of Carfilzomib if engaged in sexual activity with a pregnant female or a female of childbearing potential.
  • practice complete abstinence or understand the need and agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential throughout the entire duration of study treatment, during dose interruptions and until at least 3 months after the end of treatment discontinuation of CMP, even if he has undergone a successful vasectomy.
  • if pregnancy or a positive pregnancy test does occur in the partner of a male study patient during study participation, the investigator must be notified immediately.
  • agree not to donate semen or sperm during study drug therapy and until at least 3 months after the end of treatment discontinuation of CMP.

Who cannot join

  • any other uncontrolled medical condition or comorbidity that might interfere with subject's participation.
  • known positive for HIV or active infectious hepatitis, type B or C.
  • patient with terminal renal failure that require dialysis and clearance creatinine < 30 ml/min.
  • prior history of malignancies, other than multiple myeloma, unless the patients has been free of the disease for ≥ 5 years.
  • prior local irradiation within two weeks before first dose
  • evidence of central nervous system (CNS) involvement.
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  • unable to take corticotherapy at study entry
  • any ongoing adverse event or medical history > grade 2 severity
  • persons protected by a legal regime (guardianship, trusteeship).Alkeran's (Melphalan) contraindication: Hypersensitivity to Melphalan or to any other constituents.
  • patients with heart failure class 3 and 4 according to the NYHA criteria, or patients with past history of myocardial infarction within the last 6 months or no controlled cardiac conduction abnormalities.
  • patients with a left ventricular ejection fraction under or equal to 45 % (LVEF ≤ 45%)

Trial locations and contacts

33 sites in 1 country.

33 sites in 1 country

France33 sites

  • Centre Hospitalier H. Duffaut

    Avignon, 84902

  • Centre Hospitalier de la côte basque

    Bayonne, 64109

  • Hôpital Jean Minjoz

    Besançon, 25030

  • Institut Bergonie

    Bordeaux, 33076

  • Polyclinique Bordeaux Nord Aquitaine

    Bordeaux, 33300

  • Centre Hospitalier William Morey

    Chalon-sur-Saône, 71100

  • Centre Hospitalier de Chambery

    Chambéry, 73011

  • Hôpital St Antoine Béclére

    Clamart, 92140

  • CH Louis Pasteur

    Colmar, 68024

  • CH Francilien

    Corbeil-Essonnes, 91106

  • CHU Henri Mondor

    Créteil, 94010

  • Hématologie Clinique, CHU, Hôpital d'Enfants

    Dijon, 21000

  • Centre hospitalier départemental La Roche sur Yon

    La Roche-sur-Yon, 85025

  • Centre Jean Bernard

    Le Mans, 72000

  • Hôpital St Vincent de Paul - GH-ICL

    Lille, 59020

  • Chru Lille

    Lille, 59037

  • CHU de Limoges

    Limoges, 87000

  • Hématologie, Institut Paoli Calmette

    Marseille, 13273

  • CH Meaux

    Meaux, 77104

  • Hôpital Notre Dame de Bon Secours

    Metz, 57038

  • Hopital J Monod

    Montivilliers, 76290

  • Hôpital E Muller

    Mulhouse, 68100

  • CHRU, Hôtel Dieu

    Nantes, 44035

  • Centre de NICE 2/ Hôpital Archet

    Nice, 06202

  • CHU Nimes CAREMEAU

    Nîmes, 30029

  • Hôpital St Antoine

    Paris, 75571

  • Groupe hospitalier Pitié Salpétrière

    Paris, 75651

  • Unité de Recherche Clinique - CH Perigueux

    Périgueux, 24019

  • Hôpital Haut-Leveque

    Pessac, 33604

  • Centre Hospitalier Lyon Sud -1

    Pierre-Bénite, 69495

  • Hématologie Clinique, Hôpital Robert Debré, CHU Reims

    Reims, 51092

  • Hématologie, IUCT oncopole

    Toulouse, 31059

  • CHRU, Hôpitaux de Brabois

    Vandœuvre-lès-Nancy, 54511

Other trials in France

About this study

Official title: A Multicenter Open Label Phase 2 Study of Carfilzomib Weekly Plus Melphalan and Prednisone in Untreated Symptomatic Elderly Multiple Myeloma

IFM 2012-03 protocol is a Phase 2 multicenter nonrandomized open in elderly patients with multiple myeloma at diagnosis. Study primary objectives are in the first step to determine Maximum tolerated dose (MTD) of Carfilzomib Weekly based on definition of Dose-limiting toxicities (DLTs) and in the second step to expanded cohort, to determine the VGPR (Very Good Partial Response) + CR (Complete Response) rate of Carfilzomib Weekly at the MTD in combination with Melphalan Prednisone at the end of the 9 induction cycles.

Read the detailed description

Overall design. This study is a Multicenter, Open-label, Phase 2 study of Carfilzomib Weekly +MP in Untreated Elderly MM. Eligible patients must have a symptomatic, untreated MM with a measurable disease. There is a dose escalation part in the study as the MTD remained to be determined for carfilzomib weekly given for 4 infusions (day 1, 8, 15, 22) on a 35-days cycle.

This study will thus comprise 2 parts. Step 1. To determine MTD of Carfilzomib Weekly based on definition of DLTs - (N=6 patients per cohort, maximum 5 cohorts of carfilzomib weekly +MP) The patients will be included into three cohorts at 36 mg/m², 45 mg/m², 56 mg/m² and 70mg/m² of Carfilzomib Weekly given for 4 infusions (day 1, 8, 15, 22) +MP given on days 1 to 4 of a 35-days cycle. Carfilzomib will be administered at a dose of 36mg/m² for the first cohort where the 20 mg/m² dose is administered on Day 1 of Cycle 1 only and then 36 mg/m² for all subsequent doses.

If dose-limiting toxicities (DLTs) occur in fewer or equal than 2 of these patients, the next cohort of 6 patients (cohort 2) will be opened and patients will receive a dose of 20/45 mg/m². If DLTs occur in fewer or equal than 2 of the patients in cohort 2, the third cohort of 6 patients will receive a dose of 20/56 mg/m² where the 20 mg/m² dose is administered on Day 1 of Cycle 1 only and then 56 mg/m² for all subsequent doses. If DLTs occur in fewer or equal than 2 of the patients in cohort 3, the fourth and five cohort of 6 patients will receive a dose of 20/70 mg/m² where the 20 mg/m² dose is administered on Day 1 of Cycle 1 only and then 70 mg/m² for all subsequent doses.

If at any time during cycle 1 of a dose cohort, > 2 subjects experience a drug-related DLT, the MTD will have been exceeded, additional enrolment within the cohort will cease, and dose escalation will stop. The MTD will be defined as the dose level below which DLT is observed in > 33% (i.e. > 2 of 6) subjects in a cohort.

The following are defined as DLTs:

  • Any hematologic toxicity of grade 4 intensity or preventing administration of 2 or more of the 4 carfilzomib doses of the first treatment cycle
  • Grade ≥ 3 febrile neutropenia
  • Grade ≥ 3 gastrointestinal toxicities
  • Any other grade ≥ 3 nonhematologic toxicity considered related to CMP by the principal investigator.
  • Grade ≥ 3 peripheral neuropathy persisting for more than 3 weeks after discontinuation of study drugs.

Exceptions are:

  1. grade 4 thrombocytopenia without bleeding lasting ≤ 7 days or
  2. grade 4 neutropenia lasting ≤ 7 days
  3. grade ≥ 3 nausea/ vomiting if the patient had not received adequate antiemetic prophylaxis Adverse events (AEs) will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE, version 4.0). MTD determination will be based on occurrence of DLTs during the first induction treatment cycle only.

Step 2. Expanded Cohort (N=50 patients; Carfilzomib weekly at the MTD +MP only) After identification of the MTD, it is planned for the dose cohort to be expanded to include up to a total of 50 patients treated at the MTD of carfilzomib weekly for the step 2 of the study. A full treatment course is the same as for step 1, see "dosing regimen".

Being tested
Carfilzomib
Keywords
Carfilzomib weekly, and Melphalan and Prednisone
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CarfilzomibDrug

    Also called Melphalan, Prednisone

    DOSING REGIMEN.

    The regimen will have 2 parts:

    Part 1. Induction. Nine 5 weeks cycles (35-days each) of weekly Carfilzomib Melphalan Prednisone are planned Carfilzomib. 36, 45, 56 or 70 mg/m² on days 1, 8, 15, 22 IV route followed by a 13-day rest period per 35-days cycle. Patients will start the first cycle day 1 with 20mg/m².

    In combination with oral Melphalan 0.25mg/kg/j and oral prednisone 60mg/m², both on days 1 to 4.

    Part 2. Maintenance. Carfilzomib. 36 mg/m² weekly, every two weeks IV route for 1 year. Melphalan and Prednisone is not pursued at this phase of the study.

Study groups in NCT02302495
Study groupRoleWhat they receive
Carfilzomib weekly+Melphalan+PrednisoneOtherone arm, two steps and two parts.In the first step of the study: 5 cohorts of 6 patients with Carfilzomib weekly administrated at different dose regimen will be opened one after the other to determine Maximum tolerated dose of Carfilzomib based on definition of Dose-limiting toxicities.In the second step of the study:expanded Cohort, 50 patients received Carfilzomib at the MTD. In Part 1. Induction.Nine 5 weeks cycles of weekly CMP are plannedCarfilzomib. 36, 45, 56 or 70 mg/m² on days 1, 8, 15, 22 IV route . Patients will start the first cycle day 1 with 20mg/m². In combination with oral Melphalan 0.25mg/kg/j and oral prednisone 60mg/m², both on days 1 to 4.Part 2. Maintenance.Carfilzomib. 36 mg/m² weekly, every two weeks IV route for 1 year.
Receives: Drug: Carfilzomib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose Maximum Tolerate of Carfilzomib Weekly

    If dose-limiting toxicities occur in fewer than 3 of these patients per cohort, the next cohort of 6 patients (cohort 2,3 and 4) will be open. If at any time during cycle 1 of a dose cohort, > 2 subjects experience a drug-related dose-limiting toxicities, the Maximum Tolerate Dosing will have been exceeded, additional enrolment within the cohort will cease, and dose escalation will stop. The Maximum Tolerate Dosing will be defined as the dose level below which dose-limiting toxicities is observed in >33% subjects in a cohort.

    Measured: 35 days

Secondary outcomes (1)

  1. number of patients who reach Very Good Partial Response and Complete

    Expanded cohort, the primary endpoint is the Very Good Partial Response and Complete Response rate of Carfilzomib Weekly at the Maximum Tolerate Dosing and melphalan prednisone at the end of the 9 induction cycles using International Myeloma Working Group response criteria.

    Measured: 315 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Nov 2014 (estimated)
  2. Study start8 Jan 2014
  3. Primary completion17 Jul 2016
  4. Study completion31 Jul 2021

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02302495
Sponsor's protocol ID
2012_32
Other IDs
2012-004490-10
Acronym
IFM2012-03
Status last verified
Apr 2026
First submitted
12 Nov 2014
Last updated
7 Apr 2026
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Leleu X, Fouquet G, Richez V, Guidez S, Duhamel A, Machuron F, Karlin L, Kolb B, Tiab M, Araujo C, Meuleman N, Malfuson JV, Bourquard P, Lenain P, Roussel M, Jaccard A, Petillon MO, Belhadj-Merzoug K, Lepeu G, Chretien ML, Fontan J, Rodon P, Schmitt A, Offner F, Voillat L, Cereja S, Kuhnowski F, Rigaudeau S, Decaux O, Humbrecht-Kraut C, Frayfer J, Fitoussi O, Roos-Weil D, Eisenmann JC, Dorvaux V, Voog EG, Attal M, Moreau P, Avet-Loiseau H, Hulin C, Facon T. Carfilzomib Weekly plus Melphalan and Prednisone in Newly Diagnosed Transplant-Ineligible Multiple Myeloma (IFM 2012-03): A Phase I Trial. Clin Cancer Res. 2019 Jul 15;25(14):4224-4230. doi: 10.1158/1078-0432.CCR-18-3642. Epub 2019 May 3.

    PubMed 31053600

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Carfilzomib in people with Multiple Myeloma, run by University Hospital, Lille at 33 sites in France.

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 13 inclusion and 11 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 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in France. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Dose Maximum Tolerate of Carfilzomib Weekly (time frame: 35 days). 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 NCT02302495, 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 7 Apr 2026.

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