Status:
ACTIVE_NOT_RECRUITING
Study Comparing Continuous Versus Fixed Duration Therapy With Daratumumab, Lenalidomide, and Dexamethasone for Relapsed Multiple Myeloma
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Multiple Myeloma in Relapse
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The incorporation of proteasome inhibitors and immunomodulatory drugs into the standard of care has improved the outcome for patients with multiple myeloma (MM) over the past 10 years. However, most p...
Detailed Description
MM is a B cells malignancy, and is one of the most frequent primary neoplasms of the bone marrow. The fundamental pathology is an expansion of a single clone of plasma cells that produce monoclonal im...
Eligibility Criteria
Inclusion
- Adult patients (≥ 18 years old)
- Documented MM in relapse according to standard criteria and requiring initiation of a first line salvage therapy.
- 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)
- 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.
Exclusion
- 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
- 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 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.
- Subject is known to be seropositive for human immunodeficiency virus (HIV), hepatitis B 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 lactation women
Key Trial Info
Start Date :
July 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2026
Estimated Enrollment :
436 Patients enrolled
Trial Details
Trial ID
NCT03836014
Start Date
July 25 2019
End Date
July 1 2026
Last Update
December 6 2024
Active Locations (1)
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1
Saint Antoine Hospital - Hematology Department
Paris, France, 75012