Pomalidomide in Combination With Low-dose Dexamethasone or Pomalidomide in Combination With Low-d… (NCT01946477) | Clinical Trial Compass
CompletedPhase 2
Pomalidomide in Combination With Low-dose Dexamethasone or Pomalidomide in Combination With Low-dose Dexamethasone and Daratumumab in Subjects With Relapsed or Refractory Multiple Myeloma Following Lenalidomide-based Therapy in the First or Second Line Setting
United States, Canada, Japan186 participantsStarted 2014-05-29
Plain-language summary
This trial will evaluate the efficacy and safety of combination of pomalidomide (POM) and low-dose dexamethasone (LD-Dex) (Cohort A) or the combination of pomalidomide (POM) , daratumumab (DARA) and low-dose dexamethasone (LD-Dex) (Cohort B) in subjects with relapsed or refractory multiple myeloma who have received a first or second line treatment of lenalidomide-based therapy.
This trial will test the hypothesis for Cohort A that the proportion of patients will have an Overall Response Rate (ORR) of \> 30 % to reveal that Pomalidomide is efficacious in pretreated patients who are refractory to lenalidomide.
This trial will test the hypothesis for Cohort B that the proportion of patients will have an Overall Response Rate (ORR) of \> 70 % to reveal that POM+DARA+LD-Dex is efficacious in pretreated patients who are refractory to lenalidomide.
This trial will test the hypothesis for Cohort C that the proportion of patients will have an Overall Response Rate (ORR) of \>60% to reveal that POM+DARA+LD-Dex is efficacious in pretreated patients who are refractory to lenalidomide. This treatment will be in only Japanese patients.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Adults (age ≥ 18 years at the time of signing the ICD) with documented diagnosis of MM and measurable disease (serum M-protein ≥ 0.5 g/dL or urine M-protein ≥ 200 mg/24 hours).
. Subjects enrolling in Cohort A (POM+LD-dex) must have received 2 prior treatment lines of anti-myeloma therapy. Subjects enrolling in Cohort B and Cohort C (POM+DARA+LD-dex) must have received 1 or 2 prior treatment lines of anti-myeloma therapy.
. All subjects must have received prior treatment with LEN or a LEN-containing regimen for at least 2 consecutive cycles as the most recent treatment regimen.
. All subjects must have documented disease progression during or after their last antimyeloma therapy.
. Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tested pomalidomide plus low-dose dexamethasone, with or without daratumumab, specifically for people whose myeloma came back or stopped responding after lenalidomide-based treatment — does my treatment history match that profile, and would my doctor consider this combination relevant to my situation?
2Since this was a Phase 2 trial that has already completed, what did the results show about the overall response rate, and how does that compare to other options available to me now?
3The trial added daratumumab to the pomalidomide and dexamethasone backbone — can my doctor explain what the potential added benefit or added risks of the three-drug combination might mean for someone in my condition?
4Because lenalidomide and pomalidomide are both immunomodulatory drugs in the same class, is there a concern about whether pomalidomide would still work effectively after my lenalidomide-based therapy, and what does the evidence from this trial suggest about that?
5Are there currently approved treatments or other completed or ongoing trials my doctor would recommend I consider alongside or instead of the regimen studied in this trial?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall Response Rate (ORR)
Timeframe: From first dose until disease progression or end of treatment whichever occurs first (Up to 130 months)
. Subjects must understand and voluntarily sign an ICD prior to any study related assessments/procedures being conducted.
. Subjects must be able to adhere to the study visit schedule and other protocol requirements.
. All subjects must provide an adequate bone marrow sample at screening that definitively evaluates the presence or absence of myelodysplastic changes.
Exclusion criteria
. Any of the following laboratory abnormalities:
. Prior history of malignancies, other than MM, unless the subject has been free of the disease for more than 5 years. Allowed exceptions include the following:
. Previous therapy with pomalidomide or daratumumab
. Hypersensitivity to thalidomide, LEN, or dex (this includes ≥ Grade 3 rash during prior thalidomide or LEN therapy)
. Subjects who received an allogeneic bone marrow or allogeneic peripheral blood stem cell transplant less than 12 months prior to initiation of study treatment and who have not discontinued immunosuppressive treatment for at least 4 weeks prior to initiation of study treatment and are currently dependent on such treatment.
. Subjects with any one of the following:
. Subjects who received any of the following within 14 days of initiation of study treatment:
. Use of any investigational agents including for the treatment of multiple myeloma within 28 days or 5 half-lives (whichever is longer) of treatment, unless approved by the sponsor.