NCT01745640

Brief Summary

The purpose of this study is to determine the efficacy and toxicity profile of Pomalidomide and Dexamethasone in relapsed or refractory Multiple Myeloma patients with deletion 17p or translocation (4;14)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for phase_2 multiple-myeloma

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 10, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

February 5, 2026

Status Verified

December 1, 2015

Enrollment Period

3.9 years

First QC Date

October 29, 2012

Last Update Submit

February 2, 2026

Conditions

Multiple Myeloma

Keywords

Multiple myelomadexamethasonepomalidomideresponsesafetydel 17pt 4-14

Outcome Measures

Primary Outcomes (1)

  • Time to disease progression (from the date of the first dose to the date of the first observation of disease progression)

    The time to progression (TTP) is the time from the start of treatment to the first documentation of disease progression or death from any cause during study, whichever occurs earlier.The Kaplan-Meier procedures will be used to characterize the time-to-event curves (TTP, OS, response duration and EFS) when there is censoring; univariate summary statistics will be provided for time to response.

    The final analysis of disease progression will be run when at least 29 events will occur (expected average of 32months ).

Secondary Outcomes (5)

  • Safety of pomalidomide and dexamethasone

    for the first 15 patients included at time they end cycle 1 (an expected average of 6 months from the first inclusion)

  • Overall Response rate (Partial Response and better), Very Good Partial Response (VGPR) + Complete Response (CR) rate and stringent Complete Response (sCR) rate to pomalidomide and dexamethasone in MM patients

    The final analysis of disease progression will be run when at least 29 events will occur (expected average of 32months from beginning of study ).

  • Time to response and Response duration of pomalidomide and dexamethasone.

    The final analysis of disease progression will be run when at least 29 events will occur (expected average of 32months from beginning of study ).

  • Overall Survival of pomalidomide and dexamethasone and event free survival

    The final analysis of disease progression will be run when at least 29 events will occur (expected average of 32months from beginning of study ).

  • Response and Time to disease progression with regards to cytogenetic abnormalities in the bone marrow tumor plasma cells

    The final analysis of disease progression will be run when at least 29 events will occur (expected average of 32months from beginning of study ).

Study Arms (1)

POMALIDOMIDE and dexamethasone treatment

EXPERIMENTAL

All patients will receive pomalidomide (4 mg/day per os) and dexamethasone (40/20 mg/wk per os) during 21 day/28 day cycle

Drug: POMALIDOMIDEDrug: Dexamethasone

Interventions

POMALIDOMIDEDRUG

hard capsule 4mg/day, oral route, from day 1 to 21 per 28 days cycle

Also known as: 4mg/day, oral route, from day 1 to 21 per 28 days cycle
POMALIDOMIDE and dexamethasone treatment
DexamethasoneDRUG

40mg (if patient \<75 years)/20mg weekly, oral route, on day 1, 8, 15, 22 per 28 days cycle

Also known as: weekly, oral route, on day 1, 8, 15, 22 per 28 days cycle
POMALIDOMIDE and dexamethasone treatment

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able to understand and voluntarily sign an informed consent form
  • Age \>18 years
  • Life expectancy \> 6 months.
  • Patients must have a Symptomatic and Progressive MM
  • Patients must have a clearly detectable and quantifiable monoclonal M-component value
  • Eastern Cooperative Oncology Group performance status score of 0, 1, or 2
  • Adequate bone marrow function, with no transfusion within 5 days prior to treatment.
  • Adequate organ function
  • Wash out period of at least 2 weeks from previous antitumor therapy or any investigational treatment.
  • Able to take antithrombotic medicines
  • 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 .
  • Female subjects of childbearing potential (FCBP) (\*) must:
  • Understand the potential teratogenic risk of the treatment and take the relative precaution mentioned in the protocol, in the Pomalidomide information sheet Agree to abstain from breastfeeding during study participation and for at least 28 days after study drug discontinuation
  • For female NOT of childbearing potential, pomalidomide is contraindicated unless the exceptions mentioned in the protocol
  • +3 more criteria

You may not qualify if:

  • Patient that will require allogeneic or autologous transplantation following pomalidomide dexamethasone treatment while in the same course.
  • Any other uncontrolled medical condition or comorbidity that might interfere with subject's participation
  • Use of any other experimental drug or therapy within 15 days of screening.
  • Patients with renal failure that require dialysis and patients with creatinine clearance \< 50 mL/min
  • Prior history of malignancies, other than multiple myeloma, unless the patients has been free of the disease for ≥3 years. Excepted those mentioned in the protocol.
  • Prior local irradiation within two weeks before screening
  • Ongoing active infection, especially ongoing pneumonitis
  • Ongoing Cardiac dysfunction
  • Inability or unwillingness to comply with birth control requirements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

CHRU-Hôpital Sud Amiens

Amiens, 80054, France

Location

Chru Caen

Caen, 14033, France

Location

CHU DIJON, Hôpital d'Enfants

Dijon, 21000, France

Location

CHRU, Hôpital A.Michallon

Grenoble, 38043, France

Location

Centre hospitalier départemental La Roche sur Yon

La Roche-sur-Yon, 85025, France

Location

Chru Lille

Lille, 59037, France

Location

Institut Paoli Calmette,

Marseille, 13273, France

Location

CHRU, Hôtel Dieu

Nantes, 44035, France

Location

Hôpital Saint-Louis

Paris, 75475, France

Location

CHU - Hôpital St Antoine,

Paris, 75571, France

Location

Hôpital Haut-Leveque

Pessac, 33604, France

Location

Centre Hospitalier Lyon Sud -1

Pierre-Bénite, 69495, France

Location

Centre Hospitalier Lyon Sud -2

Pierre-Bénite, 69495, France

Location

CHRU POITIERS-Hôpital Jean Bernard

Poitiers, 86021, France

Location

Hôpital Robert Debré, CHU Reims

Reims, 51092, France

Location

CHRU RENNES 2, Hôpital Pontchaillou

Rennes, 35033, France

Location

CHRU RENNES 1, Hôpital Sud

Rennes, 35056, France

Location

CHRU, Hôpital Purpan

Toulouse, 31059, France

Location

CHRU- Hôpital Bretonneau

Tours, 37044, France

Location

CHRU, Hôpitaux de Brabois

Vandœuvre-lès-Nancy, 54511, France

Location

Related Publications (1)

  • Leleu X, Karlin L, Macro M, Hulin C, Garderet L, Roussel M, Arnulf B, Pegourie B, Kolb B, Stoppa AM, Brechiniac S, Marit G, Thielemans B, Onraed B, Mathiot C, Banos A, Lacotte L, Tiab M, Dib M, Fuzibet JG, Petillon MO, Rodon P, Wetterwald M, Royer B, Legros L, Benboubker L, Decaux O, Escoffre-Barbe M, Caillot D, Fermand JP, Moreau P, Attal M, Avet-Loiseau H, Facon T; Intergroupe Francophone du Myelome (IFM). Pomalidomide plus low-dose dexamethasone in multiple myeloma with deletion 17p and/or translocation (4;14): IFM 2010-02 trial results. Blood. 2015 Feb 26;125(9):1411-7. doi: 10.1182/blood-2014-11-612069. Epub 2015 Jan 9.

    PMID: 25575538RESULT

MeSH Terms

Conditions

Multiple MyelomaChromosome 17 deletion

Interventions

pomalidomideDexamethasone

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Xavier LELEU, PHD

    CHRU de Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2012

First Posted

December 10, 2012

Study Start

January 1, 2012

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

February 5, 2026

Record last verified: 2015-12

Locations

FR(20)