Multiple MyelomaPhase 2PCDNCT02244125
A Multicenter Open Label Phase II Study of Pomalidomide and Cyclophosphamide and Dexamethasone in Relapse/Refractory Multiple Myeloma Patients Who Were First Treated Within the IFM/DFCI 2009 Trial (PCD)
A Phase 2 study testing PCD and Autologous transplantation (ASCT) in people with Multiple Myeloma and First Relapse, run by Institut Curie at 30 sites in France.
Trial summary
Imnovid in combination with dexamethasone is indicated in the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide (Revlimid) and bortezomib (Velcade), and have demonstrated disease progression on the last… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Myeloma, First Relapse
- What is being tested?
- PCD and Autologous transplantation (ASCT)
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 30 sitesFrance
- Study dates
- 14 Apr 2014to 29 May 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have been treated in first line within the IFM/DFCI 2009 trial to be treated within the PCD trial in second line
- Must be able to understand and voluntarily sign an informed consent form
- Must be able to adhere to the study visit schedule and other protocol requirements
- Age: 18-70 years
- Life expectancy >6 months
- Patients must have progressive (+/- symptomatic) Myeloma as defined by the IMWG criteria with increase of ≥25% from lowest response value in any one or more of the following:
Show all 61Show fewer
- Serum M-component and/or (the absolute increase must be ≥0.5 g/dl)
- Urine M-component and/or (the absolute increase must be ≥200 mg/24h)
- Only in patients without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels. The 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 hypercalcaemia (corrected serum calcium >11.5 mg/dl or 2.65mmol/l) that can be attributed solely to the plasma cell proliferative disorder.
- Patients must have a clearly detectable and quantifiable monoclonal M-component value:
- IgG (serum M-component >10g/l)
- IgA (serum M-component >5g/l)
- IgD (serum M-component >0.5g/l)
- Light chain (serum M-component >1g/l or Bence Jones >200mg/24h)
- In patients without measurable serum and urine M-protein levels and in the absence of renal failure: when the absolute serum FreeLightChain (sFLC) is ≥100mg/l and an abnormal sFLC K/λ ratio (<0.26 or>1.65) is found.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
- Adequate bone marrow function, documented within 96 hours prior to treatment without transfusion or growth factor support, defined as:
- Absolute neutrophils ≥1000/mm3
- Platelets ≥75000/mm3
- Hemoglobin ≥8.5g/dl
- Adequate organ function, documented within 96 hours prior to treatment, defined as:
- Serum SGOT/AST or SGPT/ALT <3.0 X Upper Limit of Normal (ULN)
- Serum creatinine clearance (Cockcroft-Gault formula) ≥50 ml/min
- Serum total bilirubin <2.0 mg/dl
- Wash out period of at least 2 weeks from previous antitumor therapy or any investigational treatment.
- Able to take antithrombotic medicines such as low molecular weight heparin or aspirin.
- Subjects affiliated with an appropriate social security system
- Agree to abstain from donating blood while taking study drug therapy and for at least 28 days following discontinuation of study drug therapy
- Agree not to share study medication with another person and to return all unused study drug to the investigator
- Female subjects of childbearing potential (*) must:
- Understand the potential teratogenic risk to the unborn child
- Understand the need and agree to use, and be able to comply with, two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual contact during the following time periods related to this study:
- for at least 28 days before starting study drug;
- while participating in the study;
- dose interruptions; and
- for at least 28 days after study treatment discontinuation.
- The two methods of reliable contraception must include one highly effective method and one additional effective (barrier) method. Females of childbearing potential must be referred to a qualified provider of contraceptive methods if needed. The following are examples of highly effective and additional effective methods of contraception:
- Highly effective methods:
- Intrauterine device (IUD)
- Hormonal (birth control pills, injections, implants)
- Tubal ligation
- Partner's vasectomy
- Additional effective methods:
- Male condom
- Diaphragm
- Cervical Cap
- Because of the increased risk of venous thromboembolism in patients with multiple myeloma taking pomalidomide and cyclophosphamide and dexamethasone, combined oral contraceptive pills are not recommended. If a female subject is currently using combined oral contraception the patient should switch to another one of the highly effective methods listed above. The risk of venous thromboembolism continues for 4-6 weeks after discontinuing combined oral contraception. The efficacy of contraceptive steroids may be reduced during co-treatment with dexamethasone.
- Implants and levonorgestrel-releasing intrauterine devices are associated with an increased risk of infection at the time of insertion and irregular vaginal bleeding. Prophylactic antibiotics should be considered particularly in patients with neutropenia.
- o Agree to have pregnancy testing based on the frequency outlined below.
- Medically supervised pregnancy tests with a minimum sensitivity of 25 mIU/ml must be performed for females of childbearing potential, including females of childbearing potential who commit to complete abstinence:
- Before starting study drug: females of childbearing potential must have two negative pregnancy tests prior to starting study drug. The first pregnancy test must be performed within 10-14 days prior to the start of study drug and the second pregnancy test must be performed within 24 hours prior to the start of study drug. The patient may not receive study drug until the study doctor has verified that the results of these pregnancy tests are negative.
- During study participation and for 28 days following study drug discontinuation:
- Females of childbearing potential with regular or no menstrual cycles must agree to have pregnancy tests weekly for the first 28 days of study participation and then every 28 days while on study, at study discontinuation, and at day 28 following study drug discontinuation.
- If menstrual cycles are irregular, the pregnancy testing must occur weekly for the first 28 days and then every 14 days while on study, at study discontinuation, and at days 14 and 28 following study drug discontinuation.
- Criteria for women of childbearing potential: This protocol defines a female of childbearing potential as a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy or 2) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (ie, has had menses at any time in the preceding 24 consecutive months).
- Male subjects must:
- Practice complete abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 28 days following study drug discontinuation, even if he has undergone a successful vasectomy.
- Agree not to donate semen or sperm during study drug therapy and for at least 28 days following discontinuation of study drug.
Who cannot join
- Any other uncontrolled medical condition or comorbidity that might interfere with subject's participation
- Primary amyloidosis or myeloma complicated by amyloidosis
- Pregnant or breast feeding females
- Use of any other experimental drug or therapy within 2 weeks before study treatment initiation (except local radiotherapy and/or corticosteroid until dose of dexamethasone 160mg)
- Known positive for HIV or Active infectious hepatitis, type B or C
- Patients with non-secretory MM
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- Prior history of malignancies within 10 years
- Evidence of Central Nervous System (CNS) involvement
- Any >grade 2 toxicity unresolved
- Peripheral neuropathy >grade 2
- Known hypersensitivity to thalidomide, lenalidomide, cyclophosphamide or dexamethasone
- Ongoing active infection, especially ongoing pneumonitis
- Participant with clinical signs of heart or coronary failure, or evidence of Left Ventricular Ejection Fraction (LVEF) inferior to 40%.
- Participant with myocardial infarction within 6 months prior to enrolment or have New York Heart Association (NYHA) Class III or IV heart failure, and controlled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
- Inability or unwillingness to comply with birth control requirements
- Unable to take antithrombotic medicines at study entry
- Unable to take corticotherapy at study entry
- Scheduled vaccination with a live agent such as yellow fever vaccine
- Individually deprived of liberty or placed under the authority of a tutor
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
France30 sites
CHRU Hopital Sud
Amiens, 80054
Centre Hospitalier de la côte Basque
Bayonne, 64109
Hôpital Avicenne
Bobigny, 93009
ICH - Hôpital A. Morvan
Brest, 29609
Institut d'Hématologie de Basse Normandie - IHBN
Caen, 14033
Chu Estaing
Clermont-Ferrand, 63003
CHU Henri Mondor
Créteil, 94010
CHRU Dijon
Dijon, 21000
Centre Hospitalier Général
Dunkirk, 59385
Chru Grenoble
Grenoble, 38043
Centre Hospitalier départemental de Vendée
La Roche-sur-Yon, 85925
Clinique Victor Hugo
Le Mans, 72000
CHRU - Hôpital Claude Huriez
Lille, 59037
CHU de Limoges
Limoges, 87042
Institut Paoli Calmette
Marseille, 13273
Hopital Emile Muller
Mulhouse, 68100
CHU de Nantes
Nantes, 44093
CHU Carémeau
Nîmes, 30029
Institut Curie
Paris, 750005
CHRU Hopital Saint Antoine
Paris, 75012
CHRU Hôpital Haut Lévêque
Pessac, 33604
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495
Centre Hospitalier Annecy Genevois
Pringy, 74374
CHRU Hopital Pontchaillou
Rennes, 35033
Centre Henri Becquerel
Rouen, 76038
Centre Hospitalier Yves Le Foll
Saint-Brieuc, 22027
Centre René Huguenin
Saint-Cloud, 92210
Institut Universitaire du Cancer Toulouse-Oncopôle (IUCT-O)
Toulouse, 31059
CHRU Hopital Bretonneau
Tours, 37044
CHRU Hopitaux de Brabois
Vandœuvre-lès-Nancy, 54511
About this study
Official title: A Multicenter Open Label Phase II Study of Pomalidomide and Cyclophosphamide and Dexamethasone in Relapse/Refractory Multiple Myeloma Patients Who Were First Treated Within the IFM/DFCI 2009 Trial
Imnovid in combination with dexamethasone is indicated in the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide (Revlimid) and bortezomib (Velcade), and have demonstrated disease progression on the last therapy.
Patients with relapsed and refractory multiple myeloma who have received bortezomib, lenalidomide, dexamethasone combination, considered to be the multiple myeloma optimal treatment, can access to pomalidomide under marketing authorization only as from third line of treatment.
Read more
In France this combination is not authorized for marketing for a first line treatment and only patient randomized in the IFM/DFCI 2009 trial received it.
This study concerns patients previously randomized in the IFM/DFCI 2009 trial who have received bortezomib, lenalidomide and Dexamethasone combination in first line, which at progression/relapse time therapeutic opportunities remained limited and who cannot access pomalidomide under marketing authorization.
This study is a multicentre, phase 2, open label, study testing the triple combination of pomalidomide and cyclophosphamide and dexamethasone (PCD) in multiple myeloma patients who are refractory or in first progression/relapse after a first line treatment with bortezomib and lenalidomide, an IMiDs (an Immuno Modulatory Drug and a proteasome inhibitor) according to the IFM/DFCI 2009 trial.
In the IFM/DFCI trial, patients in arm A received eight cycles of the Velcade-Revlimid-Dexamethasone combination followed by 1 year of lenalidomide maintenance, patients in arm B received 3 cycles of Velcade-Revlimid-Dexamethasone combination plus melphalan 200mg/m2 with an autologous transplantation followed by 2 cycles of Velcade-Revlimid-Dexamethasone combination consolidation and 1 year of lenalidomide maintenance.
This study will contain 3 treatment phases:
- Study treatment phase:
All patients will receive 4 cycles (28 days) of pomalidomide-cyclophosphamide-dexamethasone combination.
- Consolidation phase (depends on the initial randomization in the IFM/DFCI 2009 trial):
- For patients previously randomized in IFM/DFCI 2009's arm A:
- Melphalan 200 mg/m2 followed by Autologous Transplantation
- Three months after, 2 cycles of pomalidomide-cyclophosphamide-dexamethasone combination
- For patients previously randomized in IFM/DFCI 2009's arm B:
- 5 cycles of pomalidomide-cyclophosphamide-dexamethasone combination
- Maintenance phase (identical to all patients) subsequent cycles of pomalidomide and Dexamethasone until progression / relapse or discontinuation for any other reason.
For arm B patients, in case relapse occurs at least 12 months after the end of the maintenance IFM/DFCI 2009 trial, they could proceed to a second autologous transplantation and therefore follow the arm A procedure. The decision to proceed to a second transplant will be made by the physician and the patient.
In order to have the same amount of patients enrolled in this trial in the initial Arm A and Arm B of the IFM/DFCI 2009 trial, once 50 patients have been included in either arm A or B, subsequent patients will be eligible if they have not been initially treated as the first 50 patients from either arm.
The primary endpoint is the response rate (Partial Response (PR) or better) after 4 cycles of the triple combination pomalidomide and cyclophosphamide and dexamethasone (PCD) in the studied population using International Myeloma Working Group (IMWG) response criteria.
- Conditions
- Multiple Myeloma, First Relapse
- Being tested
- PCD, Autologous transplantation (ASCT)
- Keywords
- Myeloma, Multiple Myeloma, Relapse, Refractory, PCD, IFM/DFCI 2009, Transplantation, Autologous, Pomalidomide, Immunoglobulin, Ig, Free light Chain
- Medical subject headings
- Multiple Myeloma, Neoplasms, Plasma Cell, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCDDrug
Also called Pomalidomide-Cyclophosphamide-Dexamethasone association
STUDY TREATMENT PHASE: All patients
- 4x 28 days cycles of PCD
[Pomalidomide: 4mg/day oral route on 21 days per cycle]
[Cyclophosphamide: 300mg/day oral route on days 1, 8, 15, 22 per cycle]
[Dexamethasone: 40mg/day oral route on days 1, 2, 3, 4 and 15, 16, 17, 18 per cycle]
CONSOLIDATION PHASE: depends on previous IFM/DFCI 2009's arm:
Arm A:
- Melphalan 200mg/m2 followed by Autologous Transplantation
- 2x 28 days cycles of PCD, three months post transplantation
Arm B:
- 5x 28 days cycles of PCD
[Pomalidomide: 4mg/day oral route on 21 days per cycle]
[Cyclophosphamide: 300mg/day oral route on days 1, 8, 15, 22 per cycle]
[Dexamethasone: 40mg/day oral route on days 1, 8, 15, 22 per cycle]
MAINTENANCE PHASE: All patients
- Until progression/relapse or discontinuation for any other reason
[Pomalidomide: 4mg/day oral route on 21 days per cycle]
[Dexamethasone: 20mg/day oral route on days 1, 8, 15, 22 per cycle]
Autologous transplantation (ASCT)Procedure or surgery
Arm A:
•Melphalan 200mg/m2 followed by Autologous Transplantation
| Study group | Role | What they receive |
|---|---|---|
| Previous IFM/DFCI 2009 arm A | Other | Patients previously randomized into IFM/DFCI 2009 trial arm A (or if transplantation was not done) will receive:
* The treatment phase:
* 4 cycles of PCD (Pomalidomide-Cyclophosphamide-Dexamethasone)
* The consolidation phase:
* Melphalan 200mg/m2 followed by ASCT (Autologous Stem Cell Transplantation)
* 2 cycles of PCD (Pomalidomide-Cyclophosphamide-Dexamethasone)
* The maintenance phase: Until progression or discontinuation for any other reason
* Pomalidomide and Dexamethasone Receives: Drug: PCD |
| Previous transplantation IFM/DFCI 2009 arm B | Other | Patients previously randomized into IFM/DFCI 2009 trial arm B (RVD plus Transplant) will receive:
* The treatment phase:
* 4 cycles of PCD (Pomalidomide-Cyclophosphamide-Dexamethasone)
* The consolidation phase:
* 5 cycles of PCD (Pomalidomide-Cyclophosphamide-Dexamethasone)
* The maintenance phase: Until progression or discontinuation for any oher reason
* Pomalidomide and Dexamethasone Receives: Drug: PCD; Procedure: Autologous transplantation (ASCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate (Partial response (PR) or better)
after 4 cycles of the triple association
Measured: 4 months after treatment initiation
Secondary outcomes (1)
Safety : incidence of Adverse Events and Serious Adverse Events and laboratory abnormalities
using National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTC AE) V4.03
Measured: from consent to 28 days after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2014 (estimated)
- Study start14 Apr 2014
- Primary completionJan 2017
- Study completion29 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Collaborators
- Intergroupe Francophone du Myelome, Celgene Corporation
- Responsible party
- Sponsor
- Investigators
- KUHNOWSKI Frederique, MD, Principal investigator, Institut Curie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02244125
- Sponsor's protocol ID
- IC 2013-05
- Acronym
- PCD
- Status last verified
- Nov 2025
- First submitted
- 8 Sep 2014
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Garderet L, Kuhnowski F, Berge B, Roussel M, Devlamynck L, Petillon MO, Escoffre-Barbe M, Lafon I, Facon T, Leleu X, Karlin L, Perrot A, Stoppa AM, Royer B, Chaleteix C, Tiab M, Araujo C, Lenain P, Macro M, Belhadj K, Ikhlef S, Hulin C, Loiseau HA, Attal M, Moreau P. Pomalidomide and dexamethasone until progression after first salvage therapy in multiple myeloma. Br J Haematol. 2023 Jun;201(6):1103-1115. doi: 10.1111/bjh.18772. Epub 2023 Mar 27.
PubMed 36974007Garderet L, Kuhnowski F, Berge B, Roussel M, Escoffre-Barbe M, Lafon I, Facon T, Leleu X, Karlin L, Perrot A, Moreau P, Marit G, Stoppa AM, Royer B, Chaleteix C, Tiab M, Araujo C, Lenain P, Macro M, Voog E, Benboubker L, Allangba O, Jourdan E, Orsini-Piocelle F, Brechignac S, Eveillard JR, Belhadj K, Wetterwald M, Pegourie B, Jaccard A, Eisenmann JC, Glaisner S, Mohty M, Hulin C, Loiseau HA, Mathiot C, Attal M. Pomalidomide, cyclophosphamide, and dexamethasone for relapsed multiple myeloma. Blood. 2018 Dec 13;132(24):2555-2563. doi: 10.1182/blood-2018-07-863829. Epub 2018 Oct 3.
PubMed 30282798
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Open Label Phase II Study of Pomalidomide and Cyclophosphamide and Dexamethasone in Relapse/Refractory Multiple Myeloma Patients Who Were First Treated Within the IFM/DFCI 2009 Trial
- ClinicalTrials.gov ID
- NCT02244125
- Acronym / sponsor ID
- PCD / IC 2013-05
- Conditions
- Multiple Myeloma, First Relapse
- Keywords
- Myeloma, Multiple Myeloma, Relapse, Refractory, PCD, IFM/DFCI 2009, Transplantation, Autologous
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Collaborators
- Intergroupe Francophone du Myelome, Celgene Corporation
- Study start
- 14 Apr 2014 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- 29 May 2023 (actual)
- First posted
- 18 Sep 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.
Imnovid in combination with dexamethasone is indicated in the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide (Revlimid) and bortezomib (Velcade), and have demonstrated disease progression on the last therapy.
Patients with relapsed and refractory multiple myeloma who have received bortezomib, lenalidomide, dexamethasone combination, considered to be the multiple myeloma optimal treatment, can access to pomalidomide under marketing authorization only as from third line of treatment.
In France this combination is not authorized for marketing for a first line treatment and only patient randomized in the IFM/DFCI 2009 trial received it.
This study concerns patients previously randomized in the IFM/DFCI 2009 trial who have received bortezomib, lenalidomide and Dexamethasone combination in first line, which at progression/relapse time therapeutic opportunities remained limited and who cannot access pomalidomide under marketing authorization.
This study is a multicentre, phase 2, open label, study testing the triple combination of pomalidomide and cyclophosphamide and dexamethasone (PCD) in multiple myeloma patients who are refractory or in first progression/relapse after a first line treatment with bortezomib and lenalidomide, an IMiDs (an Immuno Modulatory Drug and a proteasome inhibitor) according to the IFM/DFCI 2009 trial.
In the IFM/DFCI trial, patients in arm A received eight cycles of the Velcade-Revlimid-Dexamethasone combination followed by 1 year of lenalidomide maintenance, patients in arm B received 3 cycles of Velcade-Revlimid-Dexamethasone combination plus melphalan 200mg/m2 with an autologous transplantation followed by 2 cycles of Velcade-Revlimid-Dexamethasone combination consolidation and 1 year of lenalidomide maintenance.
This study will contain 3 treatment phases:
- Study treatment phase:
All patients will receive 4 cycles (28 days) of pomalidomide-cyclophosphamide-dexamethasone combination.
- Consolidation phase (depends on the initial randomization in the IFM/DFCI 2009 trial):
- For patients previously randomized in IFM/DFCI 2009's arm A:
- Melphalan 200 mg/m2 followed by Autologous Transplantation
- Three months after, 2 cycles of pomalidomide-cyclophosphamide-dexamethasone combination
- For patients previously randomized in IFM/DFCI 2009's arm B:
- 5 cycles of pomalidomide-cyclophosphamide-dexamethasone combination
- Maintenance phase (identical to all patients) subsequent cycles of pomalidomide and Dexamethasone until progression / relapse or discontinuation for any other reason.
For arm B patients, in case relapse occurs at least 12 months after the end of the maintenance IFM/DFCI 2009 trial, they could proceed to a second autologous transplantation and therefore follow the arm A procedure. The decision to proceed to a second transplant will be made by the physician and the patient.
In order to have the same amount of patients enrolled in this trial in the initial Arm A and Arm B of the IFM/DFCI 2009 trial, once 50 patients have been included in either arm A or B, subsequent patients will be eligible if they have not been initially treated as the first 50 patients from either arm.
The primary endpoint is the response rate (Partial Response (PR) or better) after 4 cycles of the triple combination pomalidomide and cyclophosphamide and dexamethasone (PCD) in the studied population using International Myeloma Working Group (IMWG) response criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Previous IFM/DFCI 2009 arm A | Other | Drug: PCDPatients previously randomized into IFM/DFCI 2009 trial arm A (or if transplantation was not done) will receive: * The treatment phase: * 4 cycles of PCD (Pomalidomide-Cyclophosphamide-Dexamethasone) * The consolidation phase: * Melphalan 200mg/m2 followed by ASCT (Autologous Stem Cell Transplantation) * 2 cycles of PCD (Pomalidomide-Cyclophosphamide-Dexamethasone) * The maintenance phase: Until progression or discontinuation for any other reason * Pomalidomide and Dexamethasone |
| Previous transplantation IFM/DFCI 2009 arm B | Other | Drug: PCD, Procedure: Autologous transplantation (ASCT)Patients previously randomized into IFM/DFCI 2009 trial arm B (RVD plus Transplant) will receive: * The treatment phase: * 4 cycles of PCD (Pomalidomide-Cyclophosphamide-Dexamethasone) * The consolidation phase: * 5 cycles of PCD (Pomalidomide-Cyclophosphamide-Dexamethasone) * The maintenance phase: Until progression or discontinuation for any oher reason * Pomalidomide and Dexamethasone |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (61 listed)
- Patients must have been treated in first line within the IFM/DFCI 2009 trial to be treated within the PCD trial in second line
- Must be able to understand and voluntarily sign an informed consent form
- Must be able to adhere to the study visit schedule and other protocol requirements
- Age: 18-70 years
- Life expectancy >6 months
Key exclusion criteria (19 listed)
- Any other uncontrolled medical condition or comorbidity that might interfere with subject's participation
- Primary amyloidosis or myeloma complicated by amyloidosis
- Pregnant or breast feeding females
- Use of any other experimental drug or therapy within 2 weeks before study treatment initiation (except local radiotherapy and/or corticosteroid until dose of dexamethasone 160mg)
- Known positive for HIV or Active infectious hepatitis, type B or C
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 |
|---|---|---|
| PCDAlso: Pomalidomide-Cyclophosphamide-Dexamethasone associationSTUDY TREATMENT PHASE: All patients * 4x 28 days cycles of PCD [Pomalidomide: 4mg/day oral route on 21 days per cycle] [Cyclophosphamide: 300mg/day oral route on days 1, 8, 15, 22 per cycle] [Dexamethasone: 40mg/day oral route on days 1, 2, 3, 4 and 15, 16, 17, 18 per cycle] CONSOLIDATION PHASE: depends on previous IFM/DFCI 2009's arm: Arm A: * Melphalan 200mg/m2 followed by Autologous Transplantation * 2x 28 days cycles of PCD, three months post transplantation Arm B: * 5x 28 days cycles of PCD [Pomalidomide: 4mg/day oral route on 21 days per cycle] [Cyclophosphamide: 300mg/day oral route on days 1, 8, 15, 22 per cycle] [Dexamethasone: 40mg/day oral route on days 1, 8, 15, 22 per cycle] MAINTENANCE PHASE: All patients - Until progression/relapse or discontinuation for any other reason [Pomalidomide: 4mg/day oral route on 21 days per cycle] [Dexamethasone: 20mg/day oral route on days 1, 8, 15, 22 per cycle] | Drug | Previous IFM/DFCI 2009 arm A, Previous transplantation IFM/DFCI 2009 arm B |
| Autologous transplantation (ASCT)Arm A: •Melphalan 200mg/m2 followed by Autologous Transplantation | Procedure or surgery | Previous transplantation IFM/DFCI 2009 arm B |
Primary outcome
Response rate (Partial response (PR) or better)
Time frame: 4 months after treatment initiation
after 4 cycles of the triple association
1 secondary outcome
Safety : incidence of Adverse Events and Serious Adverse Events and laboratory abnormalities
Time frame: from consent to 28 days after the last dose
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 24 Nov 2025.
- Results publication: PubMed 36974007Garderet L, Kuhnowski F, Berge B, Roussel M, Devlamynck L, Petillon MO, Escoffre-Barbe M, Lafon I, Facon T, Leleu X, Karlin L, Perrot A, Stoppa AM, Royer B, Chaleteix C, Tiab M, Araujo C, Lenain P, Macro M, Belhadj K, Ikhlef S, Hulin C, Loiseau HA, Attal M, Moreau P. Pomalidomide and dexamethasone until progression after first salvage therapy in multiple myeloma. Br J Haematol. 2023 Jun;201(6):1103-1115. doi: 10.1111/bjh.18772. Epub 2023 Mar 27.
- Derived from this study: PubMed 30282798Garderet L, Kuhnowski F, Berge B, Roussel M, Escoffre-Barbe M, Lafon I, Facon T, Leleu X, Karlin L, Perrot A, Moreau P, Marit G, Stoppa AM, Royer B, Chaleteix C, Tiab M, Araujo C, Lenain P, Macro M, Voog E, Benboubker L, Allangba O, Jourdan E, Orsini-Piocelle F, Brechignac S, Eveillard JR, Belhadj K, Wetterwald M, Pegourie B, Jaccard A, Eisenmann JC, Glaisner S, Mohty M, Hulin C, Loiseau HA, Mathiot C, Attal M. Pomalidomide, cyclophosphamide, and dexamethasone for relapsed multiple myeloma. Blood. 2018 Dec 13;132(24):2555-2563. doi: 10.1182/blood-2018-07-863829. Epub 2018 Oct 3.
- Individual participant dataSharing planned: No
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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.
KUHNOWSKI Frederique, MD principal investigator
Institut Curie
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PCD and Autologous transplantation (ASCT) in people with Multiple Myeloma and First Relapse, run by Institut Curie at 30 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 61 inclusion and 19 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 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 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?
Response rate (Partial response (PR) or better) (time frame: 4 months after treatment initiation). 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 NCT02244125, which also lists 2 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 24 Nov 2025; AzTrials last refreshed its copy on 1 Nov 2026.