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A multi-center phase III randomized study comparing continuous versus fixed duration therapy with Daratumumab, Lenalidomide, and Dexamethasone for relapsed multiple myeloma (CONFIRM)
EU CTIS ID: 2024-511855-16-00
What this study is testing
The present randomized trial is primarily designed to show the non-inferiority in overall survival at 4 years of the Dara-Len-Dex combination for treatment of MM at first relapse administered for a fixed duration of 24 months (experimental arm) versus continuous administration (control arm) until disease progression.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adult patients (≥ 18 years old)
- Effective method of contraception for the duration of treatment and 3 months after the last dose for women of childbearing age and men with a partner of childbearing age :Progestin-only pill associated with inhibition of ovulation, Hormonal methods of contraception, including oral contraceptive pills containing a combination of estrogen + progesterone, vaginal ring, injectables, implants and intrauterine devices (IUDs), non-hormonal IUD, Bilateral tubal occlusion, Vasectomized partner with documented azoospermia 90 days after procedure and who received a medical assessment of surgical success, Intrauterine hormone release system (IUS), Complete abstinence : complete abstinence is defined as the complete avoidance of heterosexual intercourse. Complete abstinence is an acceptable form of contraception for all study drugs and must be used throughout the duration of the study and for the duration of time as specified above. It is not necessary to use any other method of contraception when complete abstinence is elected. Acceptable alternate methods of highly effective contraception must be discussed in the event that the subject chooses to forego complete abstinence
- Documented MM in relapse according to standard criteria and requiring initiation of a first line salvage therapy.
- Subject must have measurable disease as defined by any of the following :• IgG myeloma : serum monoclonal paraprotein (M-protein) level ≥ 1.0 g/dL or urine M-protein level ≥ 200 mg/24 hours or • IgA, IgM, IgD, or IgE multiple myeloma : serum M-protein level ≥ 0.5 g/dL or urine M-protein level ≥ 200 mg/24 hours; or • Light chain multiple myeloma : serum immunoglobulin free light chain ≥ 10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio.
- Subject must have received one prior line of therapy for MM
- Subject must have achieved a response (PR or better) to the prior regimen.
You likely can't join if
- Evidence of refractoriness or intolerance to lenalidomide and/or daratumumab (or another anti CD38 monoclonal antibody). If previously treated with a lenalidomide or daratumumab-containing regimen, the subject is excluded if he or she :Discontinued due to any severe adverse event related to prior lenalidomide and/or daratumumab (or another anti CD38 monoclonal antibody) treatment, or If, at any time point, the subject was refractory to any dose of lenalidomide and/or daratumumab (or another anti CD38 monoclonal antibody). Refractoriness to lenalidomide and/or daratumumab (or another anti CD38 monoclonal antibody) is defined either as : Subjects whose disease progressed within 60 days of lenalidomide and/or daratumumab (or another anti CD38 monoclonal antibody) administration; or o Subjects whose disease is nonresponsive while on lenalidomide and/or daratumumab (or another anti CD38 monoclonal antibody). Nonresponsive disease is defined as either failure to achieve at least a minimal response or development of progressive disease while on lenalidomide and/or daratumumab (or another anti CD38 monoclonal antibody).
- Subject is known to be seropositive for human immunodeficiency virus (HIV), hepatitis B (included history of previous infection) or hepatitis C.
- Creatinine clearance ≤30 mL/min (MDRD method) (lenalidomide dose adjustment will be considered for subjects with creatinine clearance 30-60 mL/min).
- Hypersensitivity to the active substance or to any of the excipients
- Pregnancy or lactaction women
- Subject has received an allogenic stem cell transplant (regardless of timing).
See the full eligibility criteria
Who can join
- Adult patients (≥ 18 years old)
- Effective method of contraception for the duration of treatment and 3 months after the last dose for women of childbearing age and men with a partner of childbearing age :Progestin-only pill associated with inhibition of ovulation, Hormonal methods of contraception, including oral contraceptive pills containing a combination of estrogen + progesterone, vaginal ring, injectables, implants and intrauterine devices (IUDs), non-hormonal IUD, Bilateral tubal occlusion, Vasectomized partner with documented azoospermia 90 days after procedure and who received a medical assessment of surgical success, Intrauterine hormone release system (IUS), Complete abstinence : complete abstinence is defined as the complete avoidance of heterosexual intercourse. Complete abstinence is an acceptable form of contraception for all study drugs and must be used throughout the duration of the study and for the duration of time as specified above. It is not necessary to use any other method of contraception when complete abstinence is elected. Acceptable alternate methods of highly effective contraception must be discussed in the event that the subject chooses to forego complete abstinence
- Documented MM in relapse according to standard criteria and requiring initiation of a first line salvage therapy.
- Subject must have measurable disease as defined by any of the following :• IgG myeloma : serum monoclonal paraprotein (M-protein) level ≥ 1.0 g/dL or urine M-protein level ≥ 200 mg/24 hours or • IgA, IgM, IgD, or IgE multiple myeloma : serum M-protein level ≥ 0.5 g/dL or urine M-protein level ≥ 200 mg/24 hours; or • Light chain multiple myeloma : serum immunoglobulin free light chain ≥ 10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio.
- Subject must have received one prior line of therapy for MM
- Subject must have achieved a response (PR or better) to the prior regimen.
- Subject must have an ECOG Performance Status score of 0, 1, or 2.
- For subjects experiencing toxicities resulting from previous therapy (including peripheral neuropathy),the toxicities must have been resolved or stabilized.
- Signed informed consent
- Affiliation to a social security system or equivalent (recipient or assign)
What rules you out
- Evidence of refractoriness or intolerance to lenalidomide and/or daratumumab (or another anti CD38 monoclonal antibody). If previously treated with a lenalidomide or daratumumab-containing regimen, the subject is excluded if he or she :Discontinued due to any severe adverse event related to prior lenalidomide and/or daratumumab (or another anti CD38 monoclonal antibody) treatment, or If, at any time point, the subject was refractory to any dose of lenalidomide and/or daratumumab (or another anti CD38 monoclonal antibody). Refractoriness to lenalidomide and/or daratumumab (or another anti CD38 monoclonal antibody) is defined either as : Subjects whose disease progressed within 60 days of lenalidomide and/or daratumumab (or another anti CD38 monoclonal antibody) administration; or o Subjects whose disease is nonresponsive while on lenalidomide and/or daratumumab (or another anti CD38 monoclonal antibody). Nonresponsive disease is defined as either failure to achieve at least a minimal response or development of progressive disease while on lenalidomide and/or daratumumab (or another anti CD38 monoclonal antibody).
- Subject is known to be seropositive for human immunodeficiency virus (HIV), hepatitis B (included history of previous infection) or hepatitis C.
- Creatinine clearance ≤30 mL/min (MDRD method) (lenalidomide dose adjustment will be considered for subjects with creatinine clearance 30-60 mL/min).
- Hypersensitivity to the active substance or to any of the excipients
- Pregnancy or lactaction women
- Subject has received an allogenic stem cell transplant (regardless of timing).
- Subjects planning to undergo a stem cell transplant prior to progression of disease on this study, ie, these subjects should not be enrolled in order to reduce disease burden prior to transplant
- Subject has a history of malignancy (other than MM) within 3 years before the date of randomization (exceptions are squamous and basal cell carcinomas of the skin, carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator is considered cured with minimal risk of recurrence within 3 years).
- Subject has known MM meningeal involvement.
- Subject has plasma cell leukemia (>2.0 × 109/L circulating plasma cells by standard differential) or Waldenström’s macroglobulinemia or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) or amyloidosis.
- Subject has any concurrent medical condition or disease (eg, active systemic infection) that is likely to interfere with study procedures or results, or that, in the opinion, of the investigator would constitute a hazard for participating in this study.
- Subject has known uncontrolled chronic obstructive pulmonary disease (COPD)
- Subject has clinically significant cardiac disease
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.