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New combo shows promise for Tough-to-Treat myeloma

NCT ID NCT01745640

Disease control Sponsor: University Hospital, Lille Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a combination of pomalidomide and dexamethasone in 63 patients with multiple myeloma that had returned or stopped responding to treatment, and who had specific high-risk genetic changes. The goal was to see how well the drugs controlled the disease and what side effects occurred. The results help doctors understand if this treatment can slow cancer growth in this difficult-to-treat group.

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 combination could offer a treatment option for multiple myeloma patients with high-risk genetic features who have few alternatives.
What could go wrong
This is a small, early-phase study (63 patients) without a comparison group. Results may not apply to all patients, and side effects like low blood counts or infections are possible.

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

63 people

The number who actually took part.

Start date

Jan 2012

Finished

Dec 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.

inclusion criteria: * 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 * Understand the hazards and necessary precautions associated with the use of pomalidomide * Male subjects must: * Understand the potential teratogenic risk and take the relative precaution mentioned in the protocol, in the Pomalidomide information sheet Exclusion criteria : * 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

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Conditions

The condition(s) this trial relates to.

chromosome 17p deletion plasma cell myeloma

As listed by the trial registrant

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

Multiple myeloma

Contacts and locations

Locations

  • CHRU POITIERS-Hôpital Jean Bernard

    Poitiers, 86021, France

  • CHRU RENNES 1, Hôpital Sud

    Rennes, 35056, France

  • CHRU RENNES 2, Hôpital Pontchaillou

    Rennes, 35033, France

  • CHRU, Hôpital A.Michallon

    Grenoble, 38043, France

  • CHRU, Hôpital Purpan

    Toulouse, 31059, France

  • CHRU, Hôpitaux de Brabois

    Vandœuvre-lès-Nancy, 54511, France

  • CHRU, Hôtel Dieu

    Nantes, 44035, France

  • CHRU- Hôpital Bretonneau

    Tours, 37044, France

  • CHRU-Hôpital Sud Amiens

    Amiens, 80054, France

  • CHU - Hôpital St Antoine,

    Paris, 75571, France

  • CHU DIJON, Hôpital d'Enfants

    Dijon, 21000, France

  • Centre Hospitalier Lyon Sud -1

    Pierre-Bénite, 69495, France

  • Centre Hospitalier Lyon Sud -2

    Pierre-Bénite, 69495, France

  • Centre hospitalier départemental La Roche sur Yon

    La Roche-sur-Yon, 85025, France

  • Chru Caen

    Caen, 14033, France

  • Chru Lille

    Lille, 59037, France

  • Hôpital Haut-Leveque

    Pessac, 33604, France

  • Hôpital Robert Debré, CHU Reims

    Reims, 51092, France

  • Hôpital Saint-Louis

    Paris, 75475, France

  • Institut Paoli Calmette,

    Marseille, 13273, France

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