A Study of Melphalan Flufenamide (Melflufen)-Dex or Pomalidomide-dex for RRMM Patients Refractory to Lenalidomide (OCEAN)
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|ClinicalTrials.gov Identifier: NCT03151811|
Recruitment Status : Active, not recruiting
First Posted : May 12, 2017
Results First Posted : July 27, 2022
Last Update Posted : September 21, 2022
|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: Melphalan flufenamide (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)|
|Actual Enrollment :||495 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 12, 2017|
|Actual Primary Completion Date :||July 2, 2021|
|Estimated Study Completion Date :||September 2024|
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: Melphalan Flufenamide
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 ]Progression Free Survival defined as the duration in months from randomization until first evidence of confirmed disease progression, 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 up to 24 months after end of treatment. Median time to best response was 2.1 and 2.0 months for Arm A and B, respectively. ]ORR defined as the proportion of patients for whom the best overall confirmed response is stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR), as assessed by IRC.
- Duration of Response (DOR) [ Time Frame: From first evidence of response until confirmed progression, or if no progression, 24 months after end of treatment ]DOR defined as the duration in months from first documentation of a confirmed response to first evidence of confirmed disease progression or death due to any cause.
- Overall Survival (OS) [ Time Frame: From randomization until end of study (2 years after confirmed progression) ]OS defined as the time in months from randomization to date of death due to any cause. Patients who are alive will be censored at the last follow up visit or data cut-off date for patients still on-study.
- 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 the last dose of study treatment, the median time frame for study treatment was 25.1 and 22.1 months for Arm A and B, respectively. ]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
|Principal Investigator:||Pieter Sonneveld, Prof.||Erasmus Medical Center|