A Study of Melflufen-dex or Pomalidomide-dex for RRMM Patients Refractory to Lenalidomide (OCEAN)
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|ClinicalTrials.gov Identifier: NCT03151811|
Recruitment Status : Recruiting
First Posted : May 12, 2017
Last Update Posted : March 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: Melflufen Drug: Pomalidomide Drug: Dexamethasone||Phase 3|
This is a randomized, controlled, open-label, Phase 3 multicenter study which will enroll patients with RRMM following 2-4 lines of prior therapy and who are refractory to lenalidomide in the last line of therapy as demonstrated by disease progression on or within 60 days of completion of the last dose of lenalidomide.
Patients will be randomized to either one of two arms:
Arm A: Melflufen 40 mg on Day 1 and dexamethasone 40 mg on Days 1, 8, 15 and 22 of each 28-day cycle.
Arm B: Pomalidomide 4 mg daily on Days 1 to 21 and dexamethasone 40 mg on Days 1, 8, 15 and 22 of each 28-day cycle.
Patients ≥ 75 years of age will have a reduced dose of dexamethasone of 20 mg on Days 1, 8, 15 and 22 for both Arm A and Arm B.
Patients may receive treatment until such time as there is documented disease progression, unacceptable toxicity or the patient/treating physician determines it is not in the patient's best interest to continue.
Dose modifications and delays in therapy may be implemented based on patient tolerability as detailed in the protocol. In the event of a cycle delay, unrelated to dexamethasone toxicity, it is recommended to continue dexamethasone weekly.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||450 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Randomized, Controlled, Open-label, Phase 3 Study of Melflufen/Dexamethasone Compared With Pomalidomide/Dexamethasone for Patients With Relapsed Refractory Multiple Myeloma Who Are Refractory to Lenalidomide|
|Actual Study Start Date :||June 13, 2017|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2021|
Experimental: Arm A: Melflufen+Dexamethasone
Melflufen 40 mg i.v. on Day 1 and dexamethasone 40 mg on Days 1, 8, 15 and 22 of each 28-day cycle. Patients are to be treated until confirmed progression, unacceptable toxicity or the patient or investigator decides it is not in the patients best interest to continue.
Other Name: Ygalo
Active Comparator: Arm B: Pomalidomide+Dexamethasone
Pomalidomide 4 mg orally daily on Days 1 to 21 and dexamethasone 40 mg on Days 1, 8, 15 and 22 of each 28-day cycle. Patients are to be treated until confirmed progression, unacceptable toxicity or the patient or investigator decides it is not in the patients best interest to continue.
- Progression Free Survival (PFS) [ Time Frame: From randomization to time of progression, or, if no progression, 24 months after end of treatment ]To compare the PFS of melflufen plus dexamethasone (Arm A) versus pomalidomide plus dexamethasone (Arm B) as assessed by the Independent Review Committee (IRC) according to the International Myeloma Working Group Uniform Response Criteria (IMWG-URC)
- Overall Response Rate (ORR) [ Time Frame: From randomization until best response achieved before confirmed progression, or if no progression, 24 months after end of treatment ]To assess and compare the ORR in Arm A versus Arm B
- Duration of Response (DOR) [ Time Frame: From first evidence of response until confirmed progression, or if no progression, 24 months after end of treatment ]To assess and compare the DOR in Arm A versus Arm B
- Overall Survival (OS) [ Time Frame: From randomization until end of study (2 years after confirmed progression) ]To assess and compare OS in Arm A versus Arm B
- Safety and Tolerability: Number of patients with treatment-emergent adverse events, including clinical laboratory and vital signs abnormalities, as assessed by CTCAE v4.0 [ Time Frame: From start of dosing until 30 days after last dose ]To assess and compare safety and tolerability in Arm A versus Arm B. Number of patients with treatment-emergent adverse events, including clinical laboratory and vital signs abnormalities, as assessed by CTCAE v4.0 will be presented. No formal statistical analysis will be performed for safety endpoints.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03151811
|Contact: Head of Clinical Developmentfirstname.lastname@example.org|
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|Principal Investigator:||Pieter Sonneveld, Prof.||Erasmus Medical Center|