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Multiple MyelomaPhase 2IFM2014-01NCT03683277

IPD in RRMM Characterized With Genomic Abnormalities of Adverse Prognostic

A Phase 2 study testing Ixazomib/Pomalidomide/Dexamethasone in people with Multiple Myeloma and Relapsed and Refractory Multiple Myeloma, run by Intergroupe Francophone du Myelome at 28 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study is a Multicenter, Open-label, Phase II study of ixazomib, plus Pomalidomide and Dexamethasone regimen (IPD) in RRMM with adverse Genomic Abnormalities. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Ixazomib/Pomalidomide/Dexamethasone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
28 sitesFrance
Study dates
3 Nov 2019to 10 Feb 2023
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female patients 18 years or older.
  • Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
  • Life expectancy > 3 months.
  • Eastern Cooperative Oncology Group (ECOG) performance status and/or other performance status 0, 1, or 2.
  • Presence - at diagnosis or at relapse - of one of the following adverse genomic abnormalities determined using Interphase fluorescence in situ hybridization and Single nucleotide polymorphism (FISH/SNP) techniques at a significant rate validated centrally by Pr AVET - LOISEAU:
  • deletion 17p
Show all 40Show fewer
  • and/ or translocation (4; 14)
  • Must have an RRMM and have received a Lenalidomide line of treatment
  • Must have a Progressive Multiple Myeloma (MM) according to IMWG consensus recommendations for multiple myeloma treatment response criteria (DURIE 2007, RAJKUMAR 2011) :
  • Increase of 25% from lowest response value in any one of the following:
  • Serum M-component (absolute increase must be ≥ 0.5 g/dL),
  • Urine M-component (absolute increase must be ≥ 200 mg/24 hours),
  • Only in subjects without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC (Free Light-Chain) levels (absolute increase must be >10 mg/dL)
  • Bone marrow plasma cell percentage: the absolute percentage must be >10%
  • Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas
  • Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to the PC (Plasma Cell) proliferative disorder
  • Must have a measurable disease as defined by the following:
  • IgG (immunoglobulin G) and IgA (immunoglobulin A) (serum M-component > 5g/l)
  • IgD (immunoglobulin D) (serum M-component > 0.5g/l)
  • Light chain (Bence Jones > 200mg/24h)
  • For MM without measurable serum or urine M protein, involved FLC ≥100 mg/l and FLC abnormal ratio.
  • Patients must meet the following clinical laboratory criteria:
  • Absolute neutrophil count (ANC) ≥ 1,000/mm3 and platelet count ≥ 75,000/mm3. Platelet transfusions to help patients meet eligibility criteria are not allowed within 3 days before study enrollment.
  • Total bilirubin ≤1.5 x the upper limit of the normal range (ULN).
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN.
  • Calculated creatinine clearance ≥ 30 mL/min MDRD (Modification of Diet in Renal Disease) formula should be used for calculating creatinine clearance values: http://mdrd.com/
  • Able to undergo antithrombotic prophylactic treatment. HBPM (low weight heparin) is preferred. In case of anti-Vitamin K Agent, INR (international normalized ratio) must be used
  • Female patients who:
  • Have been postmenopausal for at least 2 years before the screening visit, OR
  • Are surgically sterile, OR
  • If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, OR
  • Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [e.g., calendar, ovulation, symptothermal and post-ovulation methods] and withdrawal are not acceptable methods of contraception.)
  • Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:
  • Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR
  • Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [e.g., calendar, ovulation, symptothermal and post-ovulation methods] and withdrawal are not acceptable methods of contraception.)
  • Patients agree:
  • not to share study medication with any other person and to return all unused study drugs to the investigator.
  • to abstain from donating blood while taking the study drug therapy and for one week following discontinuation of the study drug therapy.
  • Must be able to adhere to the study visit schedule and other protocol requirements including the pregnancy prevention program as detailed in section 13.4 of protocol
  • Affiliated with an appropriate social security system.

Who cannot join

  • Any other uncontrolled medical condition or comorbidity that might interfere with subject's participation.
  • Patients not having receive Lenalidomide
  • Pregnant or breast feeding females
  • Known positive for HIV or active hepatitis type B or C.
  • Patients with non-secretory MM
  • Patient with terminal renal failure that require dialysis and clearance creatinine < 30ml/min
Show all 27Show fewer
  • 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*
  • However, an exception (that is patients allowed to remain in the treatment phase of the study) is made for radiation therapy to a pathological fracture site to enhance bone healing or to treat post-fracture pain that is refractory to narcotic analgesics because pathologic bone fractures do not by themselves fulfill a criterion for disease progression.)
  • Evidence of central nervous system (CNS) involvement
  • Unable to take corticotherapy at study entry, Ixazomib or pomalidomide
  • Infection requiring systemic antibiotic therapy or other serious infection within 14 days before study enrollment
  • Ongoing Cardiac dysfunction: specify e.g. uncontrolled hypertension, MI (Myocardial Infarction) within 6 months, unstable Angina pectoris, Cardiac arrhythmia Grade 2 or higher
  • Patients planned to receive a transplantation while on IPd protocol
  • Patients who have had Ixazomib and Pomalidomide therapy as a previous line
  • Participation in other clinical trials, including those with other investigational agents not included in this trial, within 30 days of the start of this trial and throughout the duration of this trial.
  • Failure to have fully recovered (ie, ≤ Grade 1 toxicity) from the reversible effects of prior chemotherapy.
  • Inability or unwillingness to comply with birth control requirements
  • Unable to take antithrombotic medicines at study entry
  • Major surgery within 14 days before enrollment.
  • Systemic treatment, within 14 days before the first dose of ixazomib and Pomalidomide, with strong CYP3A (Cytochrome P450 3A) inducers (rifampicin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of St. John's wort.
  • Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
  • Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.
  • Known GI disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib and Pomalidomide including difficulty swallowing.
  • Patient has ≥ Grade 3 peripheral neuropathy, or Grade 2 with pain on clinical examination during the screening period.
  • Patients that have previously been treated with ixazomib, or participated in a study with ixazomib whether treated with ixazomib or not.
  • Subjects under juridical protection guardianship or tutelage measure

Trial locations and contacts

28 sites in 1 country.

28 sites in 1 country

France28 sites

  • CHU Angers

    Angers, 49033

  • CH Avignon - Centre Hospitalier H.Duffaut

    Avignon, 84000

  • Centre hospitalier de la côte basque

    Bayonne, 64109

  • Hôpital Avicenne

    Bobigny, 93009

  • CHU de Caen

    Caen, 14033

  • Hôpital Privé Sévigné

    Cesson-Sévigné, 35510

  • CHU Henri Mondor

    Créteil, 94010

  • CHU de Dijon

    Dijon, 21000

  • Centre hospitalier de Dunkerque

    Dunkirk, 59386

  • CHU de Grenoble

    Grenoble, 38043

  • Centre hospitalier départemental de Vendée

    La Roche-sur-Yon, 85925

  • CHRU Hôpital Claude Huriez

    Lille, 59037

  • CHU de Limoges

    Limoges, 87042

  • CHU Saint Eloi

    Montpellier, 34295

  • CHRU Hôtel Dieu

    Nantes, 44035

  • Hôpital de l'Archet 1

    Nice, 06202

  • Hôpital Saint Louis

    Paris, 75475

  • Centre Hospitalier de Périgueux

    Périgueux, 24019

  • CHU Bordeaux - Hôpital Haut Leveque

    Pessac, 33604

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • CHU de Poitiers

    Poitiers, 86021

  • CHU de Reims Hôpital Robert Debré

    Reims, 51092

  • CHU Pontchaillou

    Rennes, 35033

  • Centre Henri Becquerel

    Rouen, 76038

  • Institut de cancérologie Strasbourg Europe (ICANS)

    Strasbourg, 67091

  • Institut Universitaire du Cancer de Toulouse Oncopole

    Toulouse, 31059

  • CHRU Bretonneau

    Tours, 37044

  • Hôpitaux de Brabois - CHRU de Nancy

    Vandœuvre-lès-Nancy, 54511

Other trials in France

About this study

Official title: Multicenter Open Label Phase 2 Single Arm Study of Ixazomib, Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma Characterized With Genomic Abnormalities of Adverse Adverse Prognostic

This study is a Multicenter, Open-label, Phase II study of ixazomib, plus Pomalidomide and Dexamethasone regimen (IPD) in RRMM with adverse Genomic Abnormalities.

Read the detailed description

There is no escalation dose study, the maximum tolerated dose has already been determined in previous phase 1 escalation dose studies. The proposed dose of dexamethasone is considered standard. Patients will receive the IPd regimen until progression.

The hypothesis is that this IPd regimen based combination will eventually improve time to disease progression, with no additional toxicity, as compared to other available regimens, in this subgroup of patients with myeloma characterized with a very adverse prognosis.

Study design. This trial will study the efficacy and safety of IPd regimen in Relapsed and Refractory Multiple Myeloma with adverse Genomic Abnormalities until progression in 2 separate phases.

  • Induction phase: 17 cycles - 21-days cycles Ixazomib 3 mg D1, D4, D8 and D11 Pomalidomide 4mg D1 to D14 Dexamethasone 40 mg/d D1, D8 and D15 if patient aged <75 years Dexamethasone 20 mg/d D1, D8 and D15 if patient aged ≥ 75 years
  • Maintenance phase: until progression - 28-days cycles Ixazomib 4mg D1, D8 and D15 Pomalidomide 4mg D1 to D21
  • It is not planned for the patients to receive autologous stem-cell transplantation as part of the study trial
Being tested
Ixazomib/Pomalidomide/Dexamethasone
Medical subject headings
Multiple Myeloma, Recurrence, Genetic Diseases, Inborn

What participants receive

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

  • Ixazomib/Pomalidomide/DexamethasoneDrug

    Also called Multicentric, phase 2, RRMM, refractory, relapse, myeloma

    Treatment with association of Ixazomib, Pomalidomide and Dexamethasone (IPD)

    Induction phase : 21-days cycles - maximum of 17 cycles Ixazomib (tablets) 3 mg D1, D4, D8 and D11 Pomalidomide (tablets) 4mg D1 to D14 Dexamethasone (tablets) 40 mg/d D1, D8 and D15 if patient aged <75 years Dexamethasone (tablets) 20 mg/d D1, D8 and D15 if patient aged ≥ 75 years

    Treatment with association of Ixazomib and Pomalidomide (IP) Maintenance phase : 28-days cycles until disease progression Ixazomib (tablets) 4mg D1, D8 and D15 Pomalidomide (tablets) 4mg D1 to D21

Study groups in NCT03683277
Study groupRoleWhat they receive
Ixazomib/Pomalidomide/DexamethasoneExperimentalSingle arm treatment organized in 2 separate phases Induction phase : association of Ixazomib, Pomalidomide \& Dexamethasone (IPD) 21-days cycles - maximum of 17 cycles Ixazomib (tablets) 3 mg D1, D4, D8 and D11 Pomalidomide (tablets) 4mg D1 to D14 Dexamethasone (tablets) 40 mg/d D1, D8 and D15 if patient aged <75 years or Dexamethasone (tablets) 20 mg/d D1, D8 and D15 if patient aged ≥ 75 years Maintenance phase : association of Ixazomib and Pomalidomide (IP) 28-days cycles until disease progression Ixazomib (tablets) 4mg D1, D8 and D15 Pomalidomide (tablets) 4mg D1 to D21
Receives: Drug: Ixazomib/Pomalidomide/Dexamethasone

What is being measured

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

  1. Time to disease progression (TTP) to IPD in RRMM with adverse Genomic Abnormalities

    Time to progression (TTP), defined as time from the first induction cycle to confirmed progressive disease (PD) per the International Myeloma Working Group criteria, or death due to progressive disease, whichever occurs first. It is noted that the events (PD or death due to PD) may include those that occur in the maintenance phase. The analysis will be performed on an Intent-To-Treat (ITT) basis and then per protocol

    Measured: from Cycle 1 Day 1 of Induction phase (each Cycle is 21 days) until documented disease progression or death due to disease progression, whichever came first, assessed through study completion, an average of 18 months

Secondary outcomes (10)

  1. Incidence of Serious Adverse Events and Adverse Events as assessed by CTCAE version 4.0, dose reduction or modification

    A safety Analysis will be performed after the 10th patient enrolled has finished the first cycle of treatment, without any enrollment break. The Independent Data Monitoring Committee (IDMC) will then analyzed the following:

    • Frequency of Total Serious Adverse Events (SAE)
    • Frequency of Adverse Events (AEs) Grade 3 or higher
    • Frequency of dose reductions
    • Frequency of dose discontinuations

    Data Monitoring Committee. No enrollment break is planned unless requested by the IDMC. The IDMC will analyze:

    The interim safety analysis after the10th patient enrolled has finished the first cycle of treatment.

    Safety review along study if asked by the sponsor.

    Measured: after the 10th patient has completed the first cycle of treatment (Cycle is 21 days), an average of 5 months after the beginning of the study and then every 6 months through study end

  2. Plasma concentrations of ixazomib after twice-weekly dosing in combination with Pomalidomide and Dexamethasone

    Sparse Pharmacokinetics samples for the measurement of plasma concentrations of ixazomib will be collected in this study for the purposes of population PK and exposure-response analyses

    Measured: from Cycle 1 Day 1 to Cycle 5 day 1 of Induction phase (each cycle is 21 days)

  3. Overall Response rate (ORR, Partial Response and better) to IPD

    Post-induction and post-maintenance overall response rate (ORR) defined as the proportions of subjects who have achieved PR or better by the end of treatment per the IMWG criteria

    Measured: after completion of induction treatment of the last patient included, an average of 2 years after the beginning of the study and post maintenance treatment of the last patient included, an average of 3 years and half after the beginning of the study

  4. Very Good Partial Response (VGPR) rate to IPD

    rate of VGPR or better, defined as the proportions of subjects who have achieved PR or better by the end of induction phase per the IMWG criteria

    Measured: after completion of induction treatment of the last patient included, an average of 2 years after the beginning of the study and post maintenance treatment of the last patient included, an average of 3 years and half after the beginning of the study

  5. Complete Response (CR) rate to IPD

    CR rate defined as the proportions of subjects who have achieved CR by the end of Induction phase per IMWG criteria

    Measured: after completion of induction treatment of the last patient included, an average of 2 years after the beginning of the study and post maintenance treatment of the last patient included, an average of 3 years and half after the beginning of the study

  6. Time to response and Response duration to IPD for responders

    at the end of the study, time to response and level of response to IPD for responders patients will be analyzed

    Measured: at the end of the study treatment, an average of 3 years and half after the beginning of the study

  7. Clinical benefit response rate to IPD

    Clinical Benefit rate (CBR), Minor Response (MR) and better will be analysed at the end of the study

    Measured: at the end of the study treatment, an average of 3 years and half after the beginning of the study

  8. Overall Survival (OS) to IPD

    Overall Survival (OS) rate defined as the time in months from start of treatment and death or the termination of the study, whichever came first

    Measured: from the start of study treatment to death or the termination of the study, whichever came first, an average of 5 years

  9. Progression free survival (PFS) to IPD

    Progression free survival (PFS) defined as the time in months from start of treatment and disease progression

    Measured: from the start of study treatment to disease progression, an average of 3 years and half

  10. Event Free survival (EFS) to IPD

    Event Free survival (EFS) to IPD defined as the time in months from start of treatment and disease recurrence or onset of disease symptoms

    Measured: from the start of study treatment to death or the termination of the study, whichever came first, an average of 5 years

Timeline

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

  1. First posted25 Sep 2018
  2. Study start3 Nov 2019
  3. Primary completion31 Dec 2022
  4. Study completion10 Feb 2023

Why it stopped: Recruitment issue, 26 patients enrolled instead of 70 initially planned

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
Model description
All the patients will receive the same treatment until disease progression or end of study
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03683277
Sponsor's protocol ID
IFM 2014-01
Acronym
IFM2014-01
Status last verified
Jun 2023
First submitted
23 Aug 2018
Last updated
19 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Assouline SE, Chang J, Cheson BD, Rifkin R, Hamburg S, Reyes R, Hui AM, Yu J, Gupta N, Di Bacco A, Shou Y, Martin P. Phase 1 dose-escalation study of IV ixazomib, an investigational proteasome inhibitor, in patients with relapsed/refractory lymphoma. Blood Cancer J. 2014 Oct 17;4(10):e251. doi: 10.1038/bcj.2014.71.

    PubMed 25325301

  • Avet-Loiseau H, Attal M, Moreau P, Charbonnel C, Garban F, Hulin C, Leyvraz S, Michallet M, Yakoub-Agha I, Garderet L, Marit G, Michaux L, Voillat L, Renaud M, Grosbois B, Guillerm G, Benboubker L, Monconduit M, Thieblemont C, Casassus P, Caillot D, Stoppa AM, Sotto JJ, Wetterwald M, Dumontet C, Fuzibet JG, Azais I, Dorvaux V, Zandecki M, Bataille R, Minvielle S, Harousseau JL, Facon T, Mathiot C. Genetic abnormalities and survival in multiple myeloma: the experience of the Intergroupe Francophone du Myelome. Blood. 2007 Apr 15;109(8):3489-95. doi: 10.1182/blood-2006-08-040410. Epub 2007 Jan 5.

    PubMed 17209057

  • Avet-Loiseau H, Attal M, Campion L, Caillot D, Hulin C, Marit G, Stoppa AM, Voillat L, Wetterwald M, Pegourie B, Voog E, Tiab M, Banos A, Jaubert J, Bouscary D, Macro M, Kolb B, Traulle C, Mathiot C, Magrangeas F, Minvielle S, Facon T, Moreau P. Long-term analysis of the IFM 99 trials for myeloma: cytogenetic abnormalities [t(4;14), del(17p), 1q gains] play a major role in defining long-term survival. J Clin Oncol. 2012 Jun 1;30(16):1949-52. doi: 10.1200/JCO.2011.36.5726. Epub 2012 Apr 30.

    PubMed 22547600

  • Avet-Loiseau H, Leleu X, Roussel M, Moreau P, Guerin-Charbonnel C, Caillot D, Marit G, Benboubker L, Voillat L, Mathiot C, Kolb B, Macro M, Campion L, Wetterwald M, Stoppa AM, Hulin C, Facon T, Attal M, Minvielle S, Harousseau JL. Bortezomib plus dexamethasone induction improves outcome of patients with t(4;14) myeloma but not outcome of patients with del(17p). J Clin Oncol. 2010 Oct 20;28(30):4630-4. doi: 10.1200/JCO.2010.28.3945. Epub 2010 Jul 19.

    PubMed 20644101

  • Bergsagel PL, Mateos MV, Gutierrez NC, Rajkumar SV, San Miguel JF. Improving overall survival and overcoming adverse prognosis in the treatment of cytogenetically high-risk multiple myeloma. Blood. 2013 Feb 7;121(6):884-92. doi: 10.1182/blood-2012-05-432203. Epub 2012 Nov 19.

    PubMed 23165477

  • Chauhan D, Tian Z, Zhou B, Kuhn D, Orlowski R, Raje N, Richardson P, Anderson KC. In vitro and in vivo selective antitumor activity of a novel orally bioavailable proteasome inhibitor MLN9708 against multiple myeloma cells. Clin Cancer Res. 2011 Aug 15;17(16):5311-21. doi: 10.1158/1078-0432.CCR-11-0476. Epub 2011 Jun 30.

    PubMed 21724551

  • Chow, L.Q., et al. MLN9708, an investigational proteasome inhibitor, in patients with solid tumors; Updated phase 1 results in Head and Neck Symposium. 2012. Phoenix, AZ

  • Munshi NC, Anderson KC, Bergsagel PL, Shaughnessy J, Palumbo A, Durie B, Fonseca R, Stewart AK, Harousseau JL, Dimopoulos M, Jagannath S, Hajek R, Sezer O, Kyle R, Sonneveld P, Cavo M, Rajkumar SV, San Miguel J, Crowley J, Avet-Loiseau H; International Myeloma Workshop Consensus Panel 2. Consensus recommendations for risk stratification in multiple myeloma: report of the International Myeloma Workshop Consensus Panel 2. Blood. 2011 May 5;117(18):4696-700. doi: 10.1182/blood-2010-10-300970. Epub 2011 Feb 3.

    PubMed 21292777

  • Debes-Marun CS, Dewald GW, Bryant S, Picken E, Santana-Davila R, Gonzalez-Paz N, Winkler JM, Kyle RA, Gertz MA, Witzig TE, Dispenzieri A, Lacy MQ, Rajkumar SV, Lust JA, Greipp PR, Fonseca R. Chromosome abnormalities clustering and its implications for pathogenesis and prognosis in myeloma. Leukemia. 2003 Feb;17(2):427-36. doi: 10.1038/sj.leu.2402797.

    PubMed 12592343

  • Dewald GW, Therneau T, Larson D, Lee YK, Fink S, Smoley S, Paternoster S, Adeyinka A, Ketterling R, Van Dyke DL, Fonseca R, Kyle R. Relationship of patient survival and chromosome anomalies detected in metaphase and/or interphase cells at diagnosis of myeloma. Blood. 2005 Nov 15;106(10):3553-8. doi: 10.1182/blood-2005-05-1981. Epub 2005 Jul 19.

    PubMed 16030187

  • Dimopoulos M, Spencer A, Attal M, Prince HM, Harousseau JL, Dmoszynska A, San Miguel J, Hellmann A, Facon T, Foa R, Corso A, Masliak Z, Olesnyckyj M, Yu Z, Patin J, Zeldis JB, Knight RD; Multiple Myeloma (010) Study Investigators. Lenalidomide plus dexamethasone for relapsed or refractory multiple myeloma. N Engl J Med. 2007 Nov 22;357(21):2123-32. doi: 10.1056/NEJMoa070594.

    PubMed 18032762

  • Durie BG, Harousseau JL, Miguel JS, Blade J, Barlogie B, Anderson K, Gertz M, Dimopoulos M, Westin J, Sonneveld P, Ludwig H, Gahrton G, Beksac M, Crowley J, Belch A, Boccadaro M, Cavo M, Turesson I, Joshua D, Vesole D, Kyle R, Alexanian R, Tricot G, Attal M, Merlini G, Powles R, Richardson P, Shimizu K, Tosi P, Morgan G, Rajkumar SV; International Myeloma Working Group. International uniform response criteria for multiple myeloma. Leukemia. 2006 Sep;20(9):1467-73. doi: 10.1038/sj.leu.2404284. Epub 2006 Jul 20.

    PubMed 16855634

  • Fonseca R, Blood E, Rue M, Harrington D, Oken MM, Kyle RA, Dewald GW, Van Ness B, Van Wier SA, Henderson KJ, Bailey RJ, Greipp PR. Clinical and biologic implications of recurrent genomic aberrations in myeloma. Blood. 2003 Jun 1;101(11):4569-75. doi: 10.1182/blood-2002-10-3017. Epub 2003 Feb 6.

    PubMed 12576322

  • Gertz MA, Lacy MQ, Dispenzieri A, Greipp PR, Litzow MR, Henderson KJ, Van Wier SA, Ahmann GJ, Fonseca R. Clinical implications of t(11;14)(q13;q32), t(4;14)(p16.3;q32), and -17p13 in myeloma patients treated with high-dose therapy. Blood. 2005 Oct 15;106(8):2837-40. doi: 10.1182/blood-2005-04-1411. Epub 2005 Jun 23.

    PubMed 15976175

  • Gupta, N., M. Saleh, and K. Venkatakrishnan. Flat-Dosing Versus BSA-Based Dosing for MLN9708, An Investigational Proteasome Inhibitor: Population Pharmacokinetic (PK) Analysis of Pooled Data From 4 Phase-1 Studies in 53rd ASH Annual Meeting and Exposition. 2011. San Diego, CA; p. abstr 1433

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ixazomib/Pomalidomide/Dexamethasone in people with Multiple Myeloma and Relapsed and Refractory Multiple Myeloma, run by Intergroupe Francophone du Myelome at 28 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 40 inclusion and 27 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: stopped early, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 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 was stopped early (reason given: Recruitment issue, 26 patients enrolled instead of 70 initially planned). Results are not available in the source record.

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?

Time to disease progression (TTP) to IPD in RRMM with adverse Genomic Abnormalities (time frame: from Cycle 1 Day 1 of Induction phase (each Cycle is 21 days) until documented disease progression or death due to disease progression, whichever came first, assessed through study completion, an average of 18 months). 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 NCT03683277, which also lists 39 linked publications.

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 19 Feb 2025.

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