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Study Comparing Venetoclax and Dexamethasone with Pomalidomide and Dexamethasone for Patients with Relapsed or Refractory Multiple Myeloma

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What is this study about?

This clinical trial is focused on studying a type of blood cancer called Multiple Myeloma, specifically in patients whose cancer has returned or is not responding to treatment. The study is looking at a specific genetic feature in the cancer cells known as t(11;14). The trial will compare two different treatment combinations to see which is more effective. One group of patients will receive a combination of the medications Venetoclax and Dexamethasone, while the other group will receive Pomalidomide and Dexamethasone. Venetoclax is also known by its code name ABT-199.

The purpose of the study is to determine which treatment combination helps patients live longer without their disease getting worse. Participants will be randomly assigned to one of the two treatment groups. The study will last for a period of up to 48 weeks, during which patients will take the medications orally, meaning they will swallow them. Throughout the study, patients will have regular check-ups to monitor their health and the progress of their disease.

By participating in this study, researchers hope to gather important information about the effectiveness and safety of these treatment combinations for patients with t(11;14)-positive Multiple Myeloma. The study aims to improve understanding of how these medications work together and to potentially offer better treatment options for patients in the future.

1 randomization

Upon joining the study, you will be randomly assigned to one of two treatment groups. This means you will either receive a combination of venetoclax and dexamethasone or a combination of pomalidomide and dexamethasone. The assignment is random, similar to flipping a coin, to ensure fairness and objectivity.

2 treatment administration

If you are in the venetoclax and dexamethasone group, you will take venetoclax as a film-coated tablet by mouth. The dosage and frequency will be determined by the study team based on your specific needs.

If you are in the pomalidomide and dexamethasone group, you will take pomalidomide in the form of hard capsules by mouth. The dosage options include 1 mg, 2 mg, 3 mg, or 4 mg, and the study team will decide the appropriate dosage for you.

In both groups, you will also take dexamethasone by mouth. The dosage and frequency will be specified by the study team.

3 monitoring and follow-up

Throughout the study, regular monitoring will occur to assess your health and the effectiveness of the treatment. This includes routine check-ups, blood tests, and other necessary evaluations.

You will be asked to report any side effects or changes in your condition to the study team promptly. This information is crucial for ensuring your safety and the success of the study.

4 end of treatment

The treatment phase will continue until the study’s end date or until it is determined that the treatment is no longer beneficial for you. The estimated end date for the study is August 6, 2026.

After completing the treatment phase, a final evaluation will be conducted to assess your overall health and the outcomes of the treatment.

Who Can Join the Study?

  • Subjects must voluntarily sign and date an informed consent form, which is approved by an Independent Ethics Committee (IEC) or Institutional Review Board (IRB), before starting any study-related procedures.
  • Subjects should have certain laboratory values within the required range before the first dose of the study drug:
    • Absolute neutrophil count (ANC) should be at least 1000/μL. Neutrophils are a type of white blood cell important for fighting infections. Growth factor support can be used to meet this requirement.
    • Platelets should be at least 50,000/mm3. Platelets help with blood clotting. If more than 50% of the bone marrow is affected by myeloma, the count should be at least 30,000/mm3. No platelet transfusion should be received within 72 hours before the test.
    • Hemoglobin should be at least 8.0 g/dL. Hemoglobin is a protein in red blood cells that carries oxygen. Red blood cell transfusions can be used to meet this requirement.
    • AST and ALT should be no more than 3 times the upper limit of normal. These are liver enzymes.
    • Total bilirubin should be no more than 1.5 times the upper limit of normal, except for those with Gilbert’s syndrome.
    • Creatinine clearance should be at least 30 mL/min. This measures kidney function.
    • Serum calcium corrected for albumin should be no more than 14.0 mg/dL, or ionized calcium should be no more than 6.5 mg/dL.
  • Subjects should be willing and able to follow the procedures required in the study.
  • Subjects should be willing and able to receive treatment to prevent blood clots.
  • Subjects must have a documented diagnosis of multiple myeloma based on standard criteria.
  • Subjects must have an ECOG performance status of 2 or less. This is a scale used to assess how a disease affects a patient’s daily living abilities.
  • Subjects must have documented disease progression on or within 60 days of completing their last therapy.
  • Subjects must have received at least 2 prior lines of therapy. A line of therapy includes at least one complete cycle of treatment.
  • Subjects must not be incarcerated and must be freely willing and able to provide informed consent.
  • Subjects must have received at least 2 consecutive cycles of lenalidomide and be relapsed or refractory to it, meaning the disease has progressed or returned after treatment.
  • Subjects must have received at least 2 consecutive cycles of a proteasome inhibitor, which is a type of drug used to treat multiple myeloma.
  • Subjects must have measurable disease at screening, defined by specific levels of certain proteins in the blood or urine.
  • Subjects must have multiple myeloma that is positive for t(11;14), a specific genetic marker, as determined by a laboratory test.
  • Female subjects must have a negative pregnancy test before starting the study and at baseline before the first dose of the study drug.
  • If female, subjects must be postmenopausal, permanently surgically sterile, or using at least two effective methods of birth control from 30 days before starting the study through 30 days after the last dose of the study drug.
  • If male, subjects who are sexually active with female partners of childbearing potential must agree to use effective contraception from the first day of the study through 30 days after the last dose of the study drug.
  • Subjects must be adult males or females aged 18 years or older.

Who Cannot Join the Study?

  • Patients with a history of other types of cancer, unless they have been cancer-free for at least 5 years.
  • Patients who have had a heart attack or stroke in the past 6 months.
  • Patients with uncontrolled high blood pressure.
  • Patients with severe liver disease.
  • Patients with severe kidney disease.
  • Patients who are pregnant or breastfeeding.
  • Patients who have an active infection that requires treatment.
  • Patients who have received another investigational drug within the last 30 days.
  • Patients with known allergies to the study drugs.
  • Patients with a history of severe allergic reactions.
  • Patients who are unable to follow the study procedures.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario De Salamanca Salamanca Spain
Centre Hospitalier Universitaire De Lille Lille France
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Azienda Ospedaliera S Maria Di Terni Terni Italy
Centre Hospitalier Lyon Sud Pierre Benite France
Hospital Universitario 12 De Octubre Madrid Spain
Virgen del Rocío University Hospital Sevilla Spain
Odense University Hospital Odense Denmark
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Alexandra Hospital Athens Greece
Fakultni Nemocnice Brno Brno Czechia
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Sygehus Lillebaelt Vejle Sygehus Vejle Denmark
Universita’ Politecnica Delle Marche Ancona Italy
Aalborg University Hospital Aalborg Denmark
Centre Hospitalier Universitaire De Nantes Nantes France
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
University Hospital Olomouc Olomouc Czechia
Hopital Beaujon Clichy France
Hospital Costa del Sol Marbella Spain
Region Sjaelland Holbæk Denmark
IRCCS CROB Rionero In Vulture Italy
Fakultni Nemocnice Ostrava Ostrava Czechia
Uxsjxdbqwj Hicjehtbx Pwlfo Sqsnaneqhts Cnxoaeq Fdpe Paris France
Tylzwzvsyv Cefphc Hkypkuzh Thessaloniki Greece
Aiumcco Oertjlnyhke Oavlmonc Rsrfprq Vglqu Sgyqi Cvhauwzn Palermo Italy
Akfnvur Orsapiehtei Ulvkriahbkpvy Clfejsrcqjne Dpvur Skggif E Dlvvv Srlynxp Dl Tpnfjh Turin Italy
Cwgo Dq Noqrw Vandoeuvre Les Nancy France
Upvmympawvnegcjxotsgd Wruwupgcy Apj Wuerzburg Germany
Ibxqelbz Cspsrk Dtnbinzdcxeoohnye L'hospitalet De Llobregat Spain
Hkgzryzt Vwdm dhjomefm Barcelona Spain
Ekrdjfxoaxteerxhbfevpetmah Hludaztm og Awsrph Athens Greece

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Czechia Czechia
Not recruiting
05.11.2019
Denmark Denmark
Not recruiting
05.11.2019
France France
Not recruiting
05.11.2019
Germany Germany
Not recruiting
05.11.2019
Greece Greece
Not recruiting
05.11.2019
Italy Italy
Not recruiting
05.11.2019
Spain Spain
Not recruiting
05.11.2019

Trial locations

Investigated drugs:

Venetoclax is a medication used in this trial to help treat a type of blood cancer called multiple myeloma. It works by targeting and blocking a specific protein in cancer cells that helps them survive. By blocking this protein, venetoclax can help kill the cancer cells and slow down the progression of the disease.

Dexamethasone is a type of steroid medication that is used in combination with other drugs in this trial. It helps reduce inflammation and can also help kill cancer cells. In this study, it is used alongside other medications to enhance their effectiveness in treating multiple myeloma.

Pomalidomide is another medication used in this trial for treating multiple myeloma. It works by helping the immune system attack cancer cells and also by directly stopping the growth of these cells. Pomalidomide is used in combination with dexamethasone to improve treatment outcomes for patients with this type of cancer.

Relapsed/Refractory Multiple Myeloma – Multiple Myeloma is a type of blood cancer that affects plasma cells, which are a type of white blood cell found in the bone marrow. In relapsed or refractory cases, the disease returns after treatment or does not respond to initial therapy. The disease progresses as abnormal plasma cells multiply uncontrollably, leading to bone damage, kidney problems, and weakened immune function. Over time, the accumulation of these cells can cause bone pain, fractures, and anemia. As the disease advances, it can lead to increased calcium levels in the blood and further complications. The progression of the disease is marked by periods of remission and relapse, with symptoms worsening over time.

Trial ID:
2023-506112-40-00
Protocol code:
M13-494
NCT ID:
NCT03539744
Trial Phase:
Therapeutic confirmatory (Phase III)

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