Last hope? new combo targets myeloma that resists standard drugs
NCT ID NCT01053949
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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84 people
The number who actually took part.
- Start date
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Oct 2009
- Finished
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Apr 2015
- Lead sponsor
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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
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19 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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CHRU-Hôpital Sud, avenue Laennec,
Amiens, 80054, France
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Hématologie Clinique, CHU, Hôpital d'Enfants
Dijon, 21000, France
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Hématologie Clinique, Hôpital Robert Debré, CHU Reims
Reims, 51092, France
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Hématologie, CHRU, Hôpital A.Michallon
Grenoble, 38043, France
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Hématologie, CHRU, Hôpital Purpan
Toulouse, 31059, France
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Hématologie, CHRU, Hôpitaux de Brabois
Nancy, 54511, France
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Hématologie, CHU, avenue G.Clemenceau
Caen, 14033, France
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Hématologie, Hôpital Avicenne
Bobigny, 93009, France
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Hématologie, Institut Paoli Calmette
Marseille, 13273, France
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Hôpital Edouard HERRIOT
Lyon, 69437, France
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Hôpital PONTCHAILLOU, CHU de RENNES
Rennes, 35033, France
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Maladies du Sang, CHRU, Hôtel Dieu
Nantes, 44035, France
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Maladies du Sang, CHU - Hôpital St Antoine
Paris, 75571, France
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Médecine Interne, CHRU, Hôpital Sud
Rennes, 35056, France
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Onco-Hématologie, CHRU- Hôpital Bretonneau
Tours, 37044, France
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Service Immuno-Hématologie, Hôpital Saint-Louis
Paris, 75475, France
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Service d'Hématologie, Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495, France
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Service des Maladies du Sang, CHRU
Lille, 59037, France
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Service des Maladies du Sang, Hôpital Haut-Levèque
Pessac, 33604, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Cheap blood count ratios eyed as window into Myeloma's inflammatory grip
- Can a t-cell engager rescue myeloma that outsmarted CAR-T?
- Can myeloma treatment work without steroids?
- Double-Drug attack on Hard-to-Treat lymphomas
- Banking blood and bone marrow to decode plasma cell disorders
- Which scan sees hidden myeloma better: PET or MRI?