IFM2009-02-Pomalidomide and Dexamethasone Phase 2 Myeloma

NCT01053949 | Completed Phase 2 DMC

• 2 other identifiers: 2009_28/09242009-013319-36
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 19

Brief Summary

The purpose of this study is to evaluate the response to pomalidomide and dexamethasone in relapse and refractory MM patients who are progressive and did not achieve at least a partial response to bortezomib and lenalidomide. This study will determine the efficacy and toxicity profile of 2 modalities of pomalidomide in patients with advanced myeloma, previously heavily treated characterized with adverse prognostic and that are in desperate need of novel therapeutics.

Conditions

Multiple Myeloma

Keywords

Multiple myeloma; dexamethasone; pomalidomide; response; safety

Outcome Measures

Primary Outcomes (1)

• To determine Response rate to pomalidomide and dexamethasone in MM patients who are progressive and did not achieve at least a partial response to bortezomib and lenalidomide

  30 months

Secondary Outcomes (6)

• To determine response and safety profile of 2 dose-regimens of pomalidomide

  30 months

• To determine Safety of pomalidomide and dexamethasone

  30 months

• To determine Time to response and Response duration of pomalidomide and dexamethasone

  30 months

• To determine Time to disease progression to pomalidomide and dexamethasone

  30 months

• Overall Survival of pomalidomide and dexamethasone

  30 months

Study Arms (2)

Drug on 21 days per 28 days cycle

ACTIVE COMPARATOR

Pomalidomide 4 mg continuous daily oral route on 21 days per 28 days cycle. The proposed dose of dexamethasone is considered standard, 40mg/day once a week.

Drug on 28 days per 28 days cycle

ACTIVE COMPARATOR

Pomalidomide 4 mg continuous daily oral route on 28 days of a 28 days cycle The proposed dose of dexamethasone is considered standard, 40mg/day once a week.

Drug: Pomalidomide

Interventions

Pomalidomide DRUG

Pomalidomide 4 mg continuous daily oral route on 21 days per 28 days cycle. The proposed dose of dexamethasone is considered standard, 40mg/day once a week.

Also known as: Actimid, CC-4047

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years\>=Age
• Life expectancy\>6 months
• Patients must have Symptomatic and Progressive Myeloma following bortezomib and/or lenalidomide treatment, defined as detailed in protocol.
• Patients must have a clearly detectable and quantifiable monoclonal M-component value\*
• ECOG performance status score of 0,1,or 2
• Adequate bone marrow function,documented within 72 hours prior to treatment without transfusion or growth factor support,defined as\*
• 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 75mg
• Subjects affiliated with an appropriate social security system
• Agree to abstain from donating blood while taking study drug therapy and for one week 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 that the study medication is expected to have a teratogenic risk-Agree to use,and be able to comply with, effective contraception\* without interruption,4 weeks before starting study drug,throughout the entire duration of study drug therapy (including dose interruptions) and for 4 weeks after the end of study drug therapy,even if she has amenorrhoea.This applies unless the subject commits to absolute and continued abstinence on a monthly basis-Understand that even if she has amenorrhea,she must follow all the advice on effective contraception-She understands the potential consequences of pregnancy and the need to rapidly consult if there is a risk of pregnancy-Agree to have a medically supervised pregnancy test with a minimum sensitivity of 25 mIU/mL on the day of the study visit or in the 3 days prior to the study visit once the subject has been on effective contraception for at least 4 weeks-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 pregnancy tests should be performed on the day of the study visit or in the 3 days prior to the study visit.This requirement also applies to women of childbearing potential who practice complete and continued abstinence
• Male subjects must:Agree to use condoms throughout study drug therapy,during any dose interruption and for one week after cessation of study therapy if their partner is of childbearing potential and has no contraception Agree not to donate semen during study drug therapy and for one week after end of study drug therapy

You may not qualify if:

• Any other uncontrolled medical condition or comorbidity that might interfere with subject's participation
• Pregnant or breast feeding females
• Use of any other experimental drug or therapy within 15 days of screening.
• Known positive for HIV or infectious hepatitis,type A, B or C.
• Patients with non-secretory MM
• Prior history of malignancies, other than multiple myeloma, unless the patients has been free of the disease for \>= 3 years.Exceptions include the following\*
• Prior local irradiation within two weeks before screening
• Evidence of central nervous system involvement
• Any\>grade 2 toxicity unresolved
• Peripheral neuropathy\>=Grade 2
• Known Hypersensitivity to Thalidomide,Lenalidomide or Dexamethasone
• Ongoing active infection,especially ongoing pneumonitis
• Ongoing Cardiac dysfunction
• Inability or unwillingness to comply with birth control requirements
• Unable to take antithrombotic medicines at study entry

Sponsors & Collaborators

• University Hospital, Lille: lead
• Celgene: collaborator

Study Sites (19)

CHRU-Hôpital Sud, avenue Laennec,

Amiens, 80054, France

Location

Hématologie, Hôpital Avicenne

Bobigny, 93009, France

Location

Hématologie, CHU, avenue G.Clemenceau

Caen, 14033, France

Location

Hématologie Clinique, CHU, Hôpital d'Enfants

Dijon, 21000, France

Location

Hématologie, CHRU, Hôpital A.Michallon

Grenoble, 38043, France

Location

Service des Maladies du Sang, CHRU

Lille, 59037, France

Location

Hôpital Edouard HERRIOT

Lyon, 69437, France

Location

Hématologie, Institut Paoli Calmette

Marseille, 13273, France

Location

Hématologie, CHRU, Hôpitaux de Brabois

Nancy, 54511, France

Location

Maladies du Sang, CHRU, Hôtel Dieu

Nantes, 44035, France

Location

Service Immuno-Hématologie, Hôpital Saint-Louis

Paris, 75475, France

Location

Maladies du Sang, CHU - Hôpital St Antoine

Paris, 75571, France

Location

Service des Maladies du Sang, Hôpital Haut-Levèque

Pessac, 33604, France

Location

Service d'Hématologie, Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

Hématologie Clinique, Hôpital Robert Debré, CHU Reims

Reims, 51092, France

Location

Hôpital PONTCHAILLOU, CHU de RENNES

Rennes, 35033, France

Location

Médecine Interne, CHRU, Hôpital Sud

Rennes, 35056, France

Location

Hématologie, CHRU, Hôpital Purpan

Toulouse, 31059, France

Location

Onco-Hématologie, CHRU- Hôpital Bretonneau

Tours, 37044, France

Location

Related Publications (1)

• Leleu X, Attal M, Arnulf B, Moreau P, Traulle C, Marit G, Mathiot C, Petillon MO, Macro M, Roussel M, Pegourie B, Kolb B, Stoppa AM, Hennache B, Brechignac S, Meuleman N, Thielemans B, Garderet L, Royer B, Hulin C, Benboubker L, Decaux O, Escoffre-Barbe M, Michallet M, Caillot D, Fermand JP, Avet-Loiseau H, Facon T; Intergroupe Francophone du Myelome. Pomalidomide plus low-dose dexamethasone is active and well tolerated in bortezomib and lenalidomide-refractory multiple myeloma: Intergroupe Francophone du Myelome 2009-02. Blood. 2013 Mar 14;121(11):1968-75. doi: 10.1182/blood-2012-09-452375. Epub 2013 Jan 14.

  PMID: 23319574 RESULT

MeSH Terms

Conditions

Multiple Myeloma

Interventions

pomalidomide

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Bruno ROYER, MD PhD

  CHRU-Hôpital Sud d'Amiens-AMIENS

  PRINCIPAL INVESTIGATOR

• Philippe RODON, MD PhD

  Centre Hospitalier de Blois -BLOIS

  PRINCIPAL INVESTIGATOR

• Sabine BRECHIGNAC, MD PhD

  Hôpital Avicenne-Bobigny- PARIS

  PRINCIPAL INVESTIGATOR

• Gerard MARIT, MD PhD

  Hôpital Haut-Levèque de Pessac-BORDEAUX

  PRINCIPAL INVESTIGATOR

• Christian BERTHOU, MD PhD

  Service d'Hématologie Clinique, CHU Morvan, BREST

  PRINCIPAL INVESTIGATOR

• Margaret MACRO, MD PhD

  Hématologie, CHU, CAEN

  PRINCIPAL INVESTIGATOR

• Denis CAILLOT, MD PhD

  Hématologie Clinique, CHU, Hôpital d'Enfants, DIJON

  PRINCIPAL INVESTIGATOR

• Brigitte PEGOURIE, MD PhD

  Hématologie, CHRU, Hôpital A.Michallon, GRENOBLE

  PRINCIPAL INVESTIGATOR

• Catherine TRAULLE, MD PhD

  Service d'Hématologie, Centre Hospitalier Lyon Sud, PIERRE BENIT

  PRINCIPAL INVESTIGATOR

• Anne Marie STOPPA, MD PhD

  Hématologie, Institut Paoli Calmette, MARSEILLE

  PRINCIPAL INVESTIGATOR

• Cyrille HULIN, MD PhD

  Hématologie, CHRU, Hôpitaux de Brabois, VANDOEUVRE

  PRINCIPAL INVESTIGATOR

• Philippe MOREAU, MD PhD

  Maladies du Sang, CHRU, Hôtel Dieu, NANTES

  PRINCIPAL INVESTIGATOR

• Jean-Gabriel FUZIBET, MD PhD

  Médecine Interne, Oncologie, Hôpital de l'Archet 1, NICE

  PRINCIPAL INVESTIGATOR

• Bernard GROSBOIS, MD PhD

  Médecine Interne, CHRU, Hôpital Sud, RENNES

  PRINCIPAL INVESTIGATOR

• Brigitte KOLB, MD PfD

  Hématologie Clinique, Hôpital Robert Debré, CHU REIMS

  PRINCIPAL INVESTIGATOR

• Laurent GARDERET, MD PhD

  Maladies du Sang, CHU - Hôpital St Antoine, PARIS

  PRINCIPAL INVESTIGATOR

• Jean-Paul FERMAND, MD PhD

  Service Immuno-Hématologie, Hôpital Saint-Louis, PARIS

  PRINCIPAL INVESTIGATOR

• Michel ATTAL, MD PhD

  Hématologie, CHRU, Hôpital Purpan, TOULOUSE

  PRINCIPAL INVESTIGATOR

• Lofti BENBOUBKER, MD PhD

  Onco-Hématologie, CHRU- Hôpital Bretonneau, TOURS

  PRINCIPAL INVESTIGATOR

• Xavier Leleu, MD PhD

  Service des maladies du sang, CHRU de Lille

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2010
• First Posted: January 22, 2010
• Study Start: October 1, 2009
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2015
• Last Updated: May 14, 2026

Record last verified: 2015-11

Locations

FR (19)