Ongoing Clinical Trials for Recurrent Plasma Cell Myeloma
There are currently 2 ongoing clinical trials investigating new treatment approaches for recurrent plasma cell myeloma, also known as relapsed or refractory multiple myeloma. These studies are testing combination therapies that include targeted antibodies and immunomodulatory drugs, conducted across multiple European countries including France, Germany, Spain, Italy, and several others.
Clinical trial locations
- Czechia
- France
- Germany
- Greece
- Hungary
- Italy
- Norway
- Poland
- Spain
- Sweden
Study Comparing Continuous and Fixed Duration Therapy with Daratumumab, Lenalidomide, and Dexamethasone for Patients with Relapsed Multiple Myeloma
This trial is investigating whether patients with relapsed disease can achieve similar outcomes with a fixed treatment period of 24 months compared to continuous therapy until disease progression. The study focuses on adults whose disease has returned after one prior line of treatment and who responded well to that previous therapy.
Inclusion criteria: Participants must be at least 18 years old with documented relapsed disease requiring new treatment. They must have received one prior therapy and achieved at least a partial response to that treatment. The disease must be measurable through specific protein levels in blood or urine. Participants need an ECOG Performance Status score of 0, 1, or 2, meaning they should be able to perform most daily activities. Women of childbearing age and men with partners of childbearing age must use effective contraception during treatment and for 3 months afterward. Participants must be affiliated with a social security system and provide signed informed consent.
Exclusion criteria: The trial excludes patients with other types of cancer unrelated to blood or bone marrow, those who had a different cancer in the past five years that has not been successfully treated, and those with serious heart, lung, liver, or kidney problems. Pregnant or breastfeeding women cannot participate. Patients with active infections requiring treatment, history of allergic reactions to the study drugs, current participation in another clinical trial, or mental health conditions that impair understanding of study instructions are also excluded.
Trial focus: The main goal is to compare two treatment approaches: continuous therapy versus fixed duration therapy for 24 months. Researchers will evaluate whether the fixed duration approach is as effective as continuous treatment in terms of overall survival over four years. The study will also assess quality of life, monitor side effects, and analyze cost-effectiveness of both approaches.
Investigational drugs: The combination includes daratumumab, a monoclonal antibody given as a subcutaneous injection that targets a specific protein on cancer cells, helping the immune system destroy them; lenalidomide, an immunomodulatory drug taken orally that helps the immune system fight cancer and stops cancer cell growth; and dexamethasone, a corticosteroid taken orally or given intravenously that reduces inflammation and enhances the effectiveness of other cancer medications.
Study Comparing Subcutaneous and Intravenous Isatuximab with Pomalidomide and Dexamethasone for Adults with Relapsed or Refractory Multiple Myeloma
This trial examines two different methods of administering isatuximab—as an injection under the skin (subcutaneous) or directly into a vein (intravenous)—when combined with pomalidomide and dexamethasone. The study aims to determine if the subcutaneous method is as effective as the intravenous method, potentially offering a more convenient option for patients.
Inclusion criteria: Participants must be adults 18 years or older with relapsed or refractory disease. They must have received at least one previous treatment that included lenalidomide and a proteasome inhibitor, either alone or in combination. The disease must be measurable, demonstrated by specific protein levels: serum M-protein of at least 0.5 g/dL, urine M-protein of at least 200 mg in 24 hours, or serum free light chain assay results showing involved FLC of at least 10 mg/dL with an abnormal ratio (less than 0.26 or more than 1.65). Participants can be of any gender.
Exclusion criteria: Patients with a different type of cancer than the one being studied are excluded. Those outside the specified age range, unable to follow study procedures, or with medical conditions that could interfere with the study or make participation unsafe cannot join. The trial also excludes pregnant or breastfeeding women, patients who recently participated in another clinical trial, those with allergies to study medications or their ingredients, patients with certain serious medical conditions like heart disease or liver problems, those taking medications that could interfere with study drugs, and patients with active infections requiring treatment.
Trial focus: The primary objective is comparing the effectiveness of subcutaneous versus intravenous administration of isatuximab when combined with pomalidomide and dexamethasone. The study will monitor participants for up to 80 weeks, collecting information on treatment effectiveness, how the body processes the medications, and overall health and satisfaction of participants.
Investigational drugs: The combination includes isatuximab, a monoclonal antibody that targets and attaches to a specific protein on cancer cells, helping the immune system identify and destroy them; pomalidomide, an immunomodulatory drug taken orally that slows or stops cancer cell growth and affects the immune system; and dexamethasone, a steroid medication taken orally that reduces inflammation, suppresses the immune system, and enhances the effects of other cancer treatments.
Summary
Both ongoing trials for recurrent plasma cell myeloma are testing combination therapies that include targeted monoclonal antibodies alongside immunomodulatory drugs and corticosteroids. The trials address important questions about treatment optimization: one examines whether treatment can be safely stopped after a fixed period rather than continued indefinitely, while the other investigates more convenient administration methods that could improve patient quality of life.
Geographically, one trial is limited to France, while the other spans ten European countries including Hungary, Greece, Poland, Italy, Spain, Sweden, Germany, Czechia, and Norway, in addition to France. This broader geographic distribution may help ensure diverse patient populations and faster enrollment. Both studies focus on patients who have received at least one prior therapy and whose disease has returned, addressing a critical need for effective treatment options in this patient population.
