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Last hope? new combo targets myeloma that resists standard drugs

NCT ID NCT01053949

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase II trial tested a combination of pomalidomide and dexamethasone in 84 patients with advanced multiple myeloma whose cancer had worsened despite treatment with bortezomib and lenalidomide. The goal was to see if this drug pair could shrink tumors and control the disease. Researchers also compared two different dosing schedules to find the safest and most effective approach.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
pomalidomide and dexamethasone
What this could lead to
If successful, this could provide a new treatment option for multiple myeloma patients who have not responded to other therapies.
What could go wrong
This is a phase II trial with only 84 participants, so results may not apply broadly. The drug combination may cause side effects and may not work for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

84 people

The number who actually took part.

Start date

Oct 2009

Finished

Apr 2015

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key inclusion criteria: * 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 * 18 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 Exclusion Criteria: * 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 * Unable to take corticotherapy at study entry * Refusal to participate in the study * Persons protected by a legal regime(guardianship,trusteeship) (\*)=described in protocol

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • CHRU-Hôpital Sud, avenue Laennec,

    Amiens, 80054, France

  • Hématologie Clinique, CHU, Hôpital d'Enfants

    Dijon, 21000, France

  • Hématologie Clinique, Hôpital Robert Debré, CHU Reims

    Reims, 51092, France

  • Hématologie, CHRU, Hôpital A.Michallon

    Grenoble, 38043, France

  • Hématologie, CHRU, Hôpital Purpan

    Toulouse, 31059, France

  • Hématologie, CHRU, Hôpitaux de Brabois

    Nancy, 54511, France

  • Hématologie, CHU, avenue G.Clemenceau

    Caen, 14033, France

  • Hématologie, Hôpital Avicenne

    Bobigny, 93009, France

  • Hématologie, Institut Paoli Calmette

    Marseille, 13273, France

  • Hôpital Edouard HERRIOT

    Lyon, 69437, France

  • Hôpital PONTCHAILLOU, CHU de RENNES

    Rennes, 35033, France

  • Maladies du Sang, CHRU, Hôtel Dieu

    Nantes, 44035, France

  • Maladies du Sang, CHU - Hôpital St Antoine

    Paris, 75571, France

  • Médecine Interne, CHRU, Hôpital Sud

    Rennes, 35056, France

  • Onco-Hématologie, CHRU- Hôpital Bretonneau

    Tours, 37044, France

  • Service Immuno-Hématologie, Hôpital Saint-Louis

    Paris, 75475, France

  • Service d'Hématologie, Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495, France

  • Service des Maladies du Sang, CHRU

    Lille, 59037, France

  • Service des Maladies du Sang, Hôpital Haut-Levèque

    Pessac, 33604, France

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