Multiple MyelomaPhase 2NCT02188368
Pomalidomide for Lenalidomide for Relapsed or Refractory Multiple Myeloma Patients
A Phase 2 study testing POM, Steroids and PLD in people with Multiple Myeloma, run by Oncotherapeutics at 12 sites in United States.
Trial summary
The purpose of this clinical research study is to evaluate the safety and effectiveness (good and bad effects) of pomalidomide given as part of a combination therapy that include more than just steroids to treat subjects with relapsed (subjects whose disease came back) or refractory (subjects whose disease did not… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- POM, Steroids and PLD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 12 sitesUnited States
- Study dates
- 7 Jul 2014to 23 Oct 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has a diagnosis of MM based on standard criteria as follows:
- Major criteria:
- plasmacytomas on tissue biopsy
- bone marrow plasmacytosis (greater than 30% plasma cells)
- monoclonal immunoglobulin (Ig) spike on serum electrophoresis IgG greater than 3.5 g/dL or IgA greater than 2.0 g/dL; kappa or lambda light chain excretion greater than 1 g/day on 24-hour urine protein electrophoresis
- Minor criteria:
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- bone marrow plasmacytosis (10% to 30% plasma cells)
- monoclonal immunoglobulin present but of lesser magnitude than given under major criteria
- lytic bone lesions
- normal IgM less than 50 mg/dL, IgA less than 100 mg/dL, or IgG less than 600 mg/dL
- Any of the following sets of criteria will confirm the diagnosis of multiple myeloma:
- any 2 of the major criteria
- major criterion 1 plus minor criterion 2, 3, or 4
- major criterion 3 plus minor criterion 1 or 3
- minor criteria 1, 2, and 3, or 1, 2, and 4
- Currently has progressive MM that has relapsed while currently receiving or within 6 months of receiving the maximum tolerated dose of lenalidomide at the physician's discretion as part of a combination treatment that includes more than just steroids in a 21-day or a 28-day cycle schedule. MM patients that are relapsed or have refractory disease, as defined below, are both eligible for enrollment provided they fulfill the other eligibility criteria:
- Patients are refractory to a lenalidomide combination regimen, when they progress while currently receiving the lenalidomide combination treatment or within 8 weeks of its last dose.
- Patients are considered relapsed, when they progress between 8 and 26- weeks from their last dose of lenalidomide as part of a lenalidomide-combination therapy that includes more than just steroids.
- Prior treatment with four days or less of a total of 400 mg of prednisone (or an equivalent potency of another steroid) for MM will not be considered a regimen
- Currently has MM with measurable disease, defined as:
- a monoclonal immunoglobulin spike on serum electrophoresis of at least 0.5 g/dL and/or
- urine monoclonal protein levels of at least 200 mg/24 hours
- for patients without measurable serum and urine M-protein levels, an abnormal free light chain ratio (normal value: 0.26 - 1.65)
- Serum free light chain (SFLC) > 100 mg/L (involved light chain) and abnormal ƙ/λ ratio
- Patients with previous clotting or thrombotic events must be able to take aspirin (acetylsalicylic acid, ASA) at 81 or 325 mg /daily as prophylactic anticoagulation (subjects intolerant to ASA may use warfarin or low molecular weight heparin) and/or antithrombotic agents.
Who cannot join
- Plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein (M-protein) and skin changes (POEMS) syndrome
- Plasma cell leukemia
- Primary amyloidosis
- Non-hematologic malignancy within the past 5 years with the exception of a) adequately treated basal cell carcinoma, squamous cell skin cancer, or thyroid cancer; b) carcinoma in situ of the cervix or breast; c) prostate cancer of Gleason Grade 6 or less with stable prostate-specific antigen levels; or d) cancer considered cured by surgical resection or unlikely to impact survival during the duration of the study, such as localized transitional cell carcinoma of the bladder or benign tumors of the adrenal or pancreas
- Impaired cardiac function or clinically significant cardiac diseases, including myocardial infarction within 6 months prior to enrollment, New York Heart Association (NYHA) Class II or greater heart failure, uncontrolled angina, clinically significant pericardial disease, severe uncontrolled ventricular arrhythmias, echocardiogram or multigated acquisition scan (MUGA) evidence of left ventricular ejection fraction (LVEF) below institutional normal within 28 days prior to enrollment, electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.
- Received the following prior therapy:
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- Pomalidomide
- Lenalidomide alone or in combination with steroids in their last treatment regimen. Interim therapy not containing lenalidomide between their last lenalidomide-containing regimen and the start of the trial.
- A melphalan-containing regimen as the immediate prior line of treatment
- Chemotherapy within 3 weeks of study drugs (6 weeks for nitrosoureas)
- Corticosteroids (>10 mg /daily prednisone or equivalent) within 3 weeks of study drugs
- Immunotherapy or antibody therapy as well as thalidomide, lenalidomide, arsenic trioxide or bortezomib within 21 days before study drugs
- Extensive radiation therapy within 28 days before study drugs. Receipt of localized radiation therapy does not preclude enrollment.
- Use of any other experimental drug or therapy within 28 days of study drugs
- Known hypersensitivity to compounds of similar chemical or biological composition to thalidomide and lenalidomide.
- The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Gabrail Cancer Center
Canton, Ohio, 44718
California Cancer Associates for Research & Excellence (cCARE)
Encinitas, California, 92024
San Juan Oncology Associates
Farmington, New Mexico, 87401
Compassionate Care Research Group
Fountain Valley, California, 92708
Wellmont Medical Associates Oncology and Hematology
Kingsport, Tennessee, 37660
Vista Oncology
Olympia, Washington, 98502
Comprehensive Cancer Center at Desert Regional Medical Center
Palm Springs, California, 92262
Rapid City Regional Hospital
Rapid City, South Dakota, 57701
VA Sierra Nevada
Reno, Nevada, 89502
Inland Hematology Oncology Medical Group, Inc
San Bernardino, California, 92404
Wellness Oncology and Hematology
West Hills, California, 91307
James R. Berenson, MD, Inc.
West Hollywood, California, 90069
About this study
Official title: A Phase 2 Study of Pomalidomide as a Replacement for Lenalidomide for Multiple Myeloma Patients Relapsed or Refractory to a Lenalidomide-Containing Combination Regimen
The purpose of this clinical research study is to evaluate the safety and effectiveness (good and bad effects) of pomalidomide given as part of a combination therapy that include more than just steroids to treat subjects with relapsed (subjects whose disease came back) or refractory (subjects whose disease did not respond to past treatment) multiple myeloma (MM).
Pomalidomide (alone or in combination with dexamethasone) has been approved by the United States Food and Drug Administration (FDA) for the treatment of MM patients who have received at least two prior therapies, including lenalidomide and bortezomib, and have demonstrated disease progression on or within 60 days of completion of their last therapy. However, the use of pomalidomide in combination with other drugs used to treat MM, such as chemotherapeutic agents and proteasome inhibitors, is currently being tested and is not approved. Pomalidomide is in the same drug class as thalidomide and lenalidomide. Like lenalidomide, pomalidomide is a drug that alters the immune system and it may also interfere with the development of small blood vessels that help support tumor growth. Therefore, in theory, it may reduce or prevent the growth of cancer cells. The testing done with pomalidomide thus far has shown that it is well-tolerated and effective for subjects with MM both on its own and in combination with dexamethasone. Using another drug class, namely proteasome inhibitors, we have demonstrated that simply replacing a proteasome inhibitor with another in an established anti-myeloma treatment regimen can frequently overcome resistance regardless of the other agents that are part of the anti-myeloma regimen. Importantly, the toxicity profile of the new combinations closely resembled that of the proteasome inhibitor administered as a single agent. Based on this experience, we hypothesize that the replacement of lenalidomide with pomalidomide will yield similar results in a similar relapsed/refractory MM patient population.
Read the detailed description
This is a phase 2, multicenter, open-label and non-randomized study to evaluate the efficacy and safety of pomalidomide as a replacement for lenalidomide among MM patients who have failed lenalidomide-containing regimens that include more than steroids within 6 months of their last dose of lenalidomide. Pomalidomide will replace lenalidomide in a combination regimen containing an alkylating agent (cyclophosphamide), anthracycline (doxorubicin or PLD), proteasome inhibitor (bortezomib or carfilzomib) and/or a glucocorticosteroid (prednisone, dexamethasone or methylprednisolone). Pomalidomide will be administered on days 1-21 of a 28-day cycle, whereas other drugs (anthracyclines, proteasome inhibitors, steroids or alkylating agents except melphalan) will be administered using the same schedule(s), dose(s) and drug combination as the last lenalidomide-containing regimen that the patient received and failed. This study will enroll patients resistant to a lenalidomide-containing combination regimen as demonstrated by PD while being treated or that has relapsed within 6 months of the last dose of lenalidomide in their last lenalidomide-containing combination regimen or while on lenalidomide or lenalidomide and steroid maintenance therapy. Forty-five patients will be enrolled in the study.
The study consists of: 1) a screening period; 2) up to eight 28-day, treatment cycles; 3) a final assessment to occur 28 days after the end of the last treatment cycle; and 4) a follow-up period.
Subjects eligible for this study will receive treatment with study drug for a maximum of eight 28-day treatment cycles, depending on the schedule of their last lenalidomide-containing regimen. Subjects are to be treated to a maximum response (lowest level of paraprotein) plus 1 additional cycle, without exceeding a total of 8 cycles, or complete 8 cycles of therapy without progressing (PD).
- Conditions
- Multiple Myeloma
- Being tested
- POM, Steroids, PLD, CFZ, BTZ
- Keywords
- Pomalidomide, Lenalidomide refractory, multiple myeloma
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POMDrug
Also called Pomalidomide, Pomalyst, Actimid, CC-4047
SteroidsDrug
Also called Dexamethasone, prednisone, methyprednisolone
PLDDrug
Also called Pegylated liposomal doxirrubicin
CFZDrug
Also called Carfilzomib, Kyprolis
BTZDrug
Also called Bortezomib, Velcade
CLADrug
Also called Clarithromycin
CYDrug
Also called Cyclophosphamide
| Study group | Role | What they receive |
|---|---|---|
| A: POM 4mg+Steroids+(CFZ, BTZ, CY or CLA) | Experimental | POM 4 mg PO days 1-21 Steroids at the same dose and on the same days as the patient's lenalidomide-containing treatment (it varies for each subject).
BTZ (bortezomib) at the same dose and on the same days as the patient's lenalidomide-containing treatment (it varies for each subject).
CFZ (carfilzomib) at the same dose and on the same days as the patient's lenalidomide-containing treatment (it varies for each subject).
CLA (clarithromycin) at the same dose and on the same days as the patient's lenalidomide-containing treatment (it varies for each subject).
CY (cyclophosphamide) at the same dose and on the same days as the patient's lenalidomide-containing treatment (it varies for each subject). Receives: Drug: POM; Drug: Steroids; Drug: CFZ; Drug: BTZ; Drug: CLA; Drug: CY |
| B: POM 3mg+PLD with or without steroids | Experimental | POM 3 mg PO days 1-21 Steroids (if the patient had received them) at the same dose and on the same days as the patient's lenalidomide-containing treatment (it varies for each subject).
PLD at the same dose and on the same days as the patient's lenalidomide-containing treatment (it varies for each subject). Receives: Drug: POM; Drug: Steroids; Drug: PLD |
| C: POM MTD + other drugs | Experimental | Phase 1:
POM at escalating doses of 2 mg (Cycle 1), 3 mg (Cycle 2) or 4 mg (Cycle 3+) All other agents at the same dose and on the same days as the patients were receiving them in the lenalidomide-containing regimen they had failed
Phase 2:
POM at the MTD All other agents, at the same dose and on the same days as phase 1 Receives: Drug: POM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD)
MTD will be determined for any ≥ three-drug combinations other than:
bortezomib + steroids + lenalidomide; carfilzomib + steroids + lenalidomide; clarithromycin + steroids + lenalidomide; cyclophosphamide + steroids + lenalidomide pegylated liposomal doxorubicin (PLD) + lenalidomide with or without steroids
Measured: Cycles 1-3 for selected regimens (up to 3 months)
Number of subjects with adverse events
Adverse events will be graded via the Common Terminology Criteria for Adverse Events (CTCAE) v 4.03 criteria.
Measured: up to 36 months
Overall Response Rate
Overall response rate (ORR): complete response (CR)+ very good partial response (VGPR) + partial response (PR)
Measured: up to 36 months
Clinical Benefit Rate (CBR)
CBR=ORR + minor response (MR)
Measured: up to 36 months
Secondary outcomes (5)
Time to Progression
The time from the initiation of therapy to progressive disease
Measured: time from initiation of therapy to progressive disease (assessed at least over 36 months)
Progression-free survival (PFS)
Time from initiation of therapy to progressive disease or death from any cause, whichever occurs first
Measured: time from initiation of therapy to progressive disease or death from any cause, whichever comes first (assessed at least over 36 months)
Time to first response (TTP)
time from initiation of therapy to the first evidence of a confirmed response
Measured: time from initiation of therapy to the first evidence of a confirmed response (up to 36 months)
Duration of response (DOR)
time from the first response (> PR) to progressive disease
Measured: time from the first response (> PR) to progressive disease (assessed at least over 36 months)
Overall survival (OS)
time from initiation of therapy to death from any cause or last follow-up visit
Measured: time from initiation of therapy to death from any cause or last follow-up visit (assessed at least over 36 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2014 (estimated)
- Study start7 Jul 2014
- Primary completion23 Oct 2020
- Study completion23 Oct 2020
Why it stopped: Lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oncotherapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Celgene Corporation
- Responsible party
- Sponsor
- Investigators
- James R Berenson, MD, Principal investigator, James R. Berenson MD, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02188368
- Sponsor's protocol ID
- PO-CL-MM-PI-003854
- Status last verified
- Nov 2023
- First submitted
- 7 Jul 2014
- Last updated
- 3 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Pomalidomide as a Replacement for Lenalidomide for Multiple Myeloma Patients Relapsed or Refractory to a Lenalidomide-Containing Combination Regimen
- ClinicalTrials.gov ID
- NCT02188368
- Acronym / sponsor ID
- PO-CL-MM-PI-003854
- Conditions
- Multiple Myeloma
- Keywords
- Pomalidomide, Lenalidomide refractory, multiple myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of enrollment
- Enrolment
- 45 participants (actual)
- Lead sponsor
- OncotherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Celgene Corporation
- Study start
- 7 Jul 2014 (actual)
- Primary completion
- 23 Oct 2020 (actual)
- Study completion
- 23 Oct 2020 (actual)
- First posted
- 11 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical research study is to evaluate the safety and effectiveness (good and bad effects) of pomalidomide given as part of a combination therapy that include more than just steroids to treat subjects with relapsed (subjects whose disease came back) or refractory (subjects whose disease did not respond to past treatment) multiple myeloma (MM).
Pomalidomide (alone or in combination with dexamethasone) has been approved by the United States Food and Drug Administration (FDA) for the treatment of MM patients who have received at least two prior therapies, including lenalidomide and bortezomib, and have demonstrated disease progression on or within 60 days of completion of their last therapy. However, the use of pomalidomide in combination with other drugs used to treat MM, such as chemotherapeutic agents and proteasome inhibitors, is currently being tested and is not approved. Pomalidomide is in the same drug class as thalidomide and lenalidomide. Like lenalidomide, pomalidomide is a drug that alters the immune system and it may also interfere with the development of small blood vessels that help support tumor growth. Therefore, in theory, it may reduce or prevent the growth of cancer cells. The testing done with pomalidomide thus far has shown that it is well-tolerated and effective for subjects with MM both on its own and in combination with dexamethasone. Using another drug class, namely proteasome inhibitors, we have demonstrated that simply replacing a proteasome inhibitor with another in an established anti-myeloma treatment regimen can frequently overcome resistance regardless of the other agents that are part of the anti-myeloma regimen. Importantly, the toxicity profile of the new combinations closely resembled that of the proteasome inhibitor administered as a single agent. Based on this experience, we hypothesize that the replacement of lenalidomide with pomalidomide will yield similar results in a similar relapsed/refractory MM patient population.
Detailed description
This is a phase 2, multicenter, open-label and non-randomized study to evaluate the efficacy and safety of pomalidomide as a replacement for lenalidomide among MM patients who have failed lenalidomide-containing regimens that include more than steroids within 6 months of their last dose of lenalidomide. Pomalidomide will replace lenalidomide in a combination regimen containing an alkylating agent (cyclophosphamide), anthracycline (doxorubicin or PLD), proteasome inhibitor (bortezomib or carfilzomib) and/or a glucocorticosteroid (prednisone, dexamethasone or methylprednisolone). Pomalidomide will be administered on days 1-21 of a 28-day cycle, whereas other drugs (anthracyclines, proteasome inhibitors, steroids or alkylating agents except melphalan) will be administered using the same schedule(s), dose(s) and drug combination as the last lenalidomide-containing regimen that the patient received and failed. This study will enroll patients resistant to a lenalidomide-containing combination regimen as demonstrated by PD while being treated or that has relapsed within 6 months of the last dose of lenalidomide in their last lenalidomide-containing combination regimen or while on lenalidomide or lenalidomide and steroid maintenance therapy. Forty-five patients will be enrolled in the study.
The study consists of: 1) a screening period; 2) up to eight 28-day, treatment cycles; 3) a final assessment to occur 28 days after the end of the last treatment cycle; and 4) a follow-up period.
Subjects eligible for this study will receive treatment with study drug for a maximum of eight 28-day treatment cycles, depending on the schedule of their last lenalidomide-containing regimen. Subjects are to be treated to a maximum response (lowest level of paraprotein) plus 1 additional cycle, without exceeding a total of 8 cycles, or complete 8 cycles of therapy without progressing (PD).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A: POM 4mg+Steroids+(CFZ, BTZ, CY or CLA) | Experimental | Drug: POM, Drug: Steroids, Drug: CFZ, Drug: BTZ, Drug: CLA, Drug: CYPOM 4 mg PO days 1-21 Steroids at the same dose and on the same days as the patient's lenalidomide-containing treatment (it varies for each subject). BTZ (bortezomib) at the same dose and on the same days as the patient's lenalidomide-containing treatment (it varies for each subject). CFZ (carfilzomib) at the same dose and on the same days as the patient's lenalidomide-containing treatment (it varies for each subject). CLA (clarithromycin) at the same dose and on the same days as the patient's lenalidomide-containing treatment (it varies for each subject). CY (cyclophosphamide) at the same dose and on the same days as the patient's lenalidomide-containing treatment (it varies for each subject). |
| B: POM 3mg+PLD with or without steroids | Experimental | Drug: POM, Drug: Steroids, Drug: PLDPOM 3 mg PO days 1-21 Steroids (if the patient had received them) at the same dose and on the same days as the patient's lenalidomide-containing treatment (it varies for each subject). PLD at the same dose and on the same days as the patient's lenalidomide-containing treatment (it varies for each subject). |
| C: POM MTD + other drugs | Experimental | Drug: POMPhase 1: POM at escalating doses of 2 mg (Cycle 1), 3 mg (Cycle 2) or 4 mg (Cycle 3+) All other agents at the same dose and on the same days as the patients were receiving them in the lenalidomide-containing regimen they had failed Phase 2: POM at the MTD All other agents, at the same dose and on the same days as phase 1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Has a diagnosis of MM based on standard criteria as follows:
- Currently has progressive MM that has relapsed while currently receiving or within 6 months of receiving the maximum tolerated dose of lenalidomide at the physician's discretion as part of a combination treatment that includes more than just steroids in a 21-day or a 28-day cycle schedule. MM patients that are relapsed or have refractory disease, as defined below, are both eligible for enrollment provided they fulfill the other eligibility criteria:
- Currently has MM with measurable disease, defined as:
- Patients with previous clotting or thrombotic events must be able to take aspirin (acetylsalicylic acid, ASA) at 81 or 325 mg /daily as prophylactic anticoagulation (subjects intolerant to ASA may use warfarin or low molecular weight heparin) and/or antithrombotic agents.
Key exclusion criteria (16 listed)
- Plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein (M-protein) and skin changes (POEMS) syndrome
- Plasma cell leukemia
- Primary amyloidosis
- Non-hematologic malignancy within the past 5 years with the exception of a) adequately treated basal cell carcinoma, squamous cell skin cancer, or thyroid cancer; b) carcinoma in situ of the cervix or breast; c) prostate cancer of Gleason Grade 6 or less with stable prostate-specific antigen levels; or d) cancer considered cured by surgical resection or unlikely to impact survival during the duration of the study, such as localized transitional cell carcinoma of the bladder or benign tumors of the adrenal or pancreas
- Impaired cardiac function or clinically significant cardiac diseases, including myocardial infarction within 6 months prior to enrollment, New York Heart Association (NYHA) Class II or greater heart failure, uncontrolled angina, clinically significant pericardial disease, severe uncontrolled ventricular arrhythmias, echocardiogram or multigated acquisition scan (MUGA) evidence of left ventricular ejection fraction (LVEF) below institutional normal within 28 days prior to enrollment, electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| POMAlso: Pomalidomide, Pomalyst, Actimid, CC-4047 | Drug | A: POM 4mg+Steroids+(CFZ, BTZ, CY or CLA), B: POM 3mg+PLD with or without steroids, C: POM MTD + other drugs |
| SteroidsAlso: Dexamethasone, prednisone, methyprednisolone | Drug | A: POM 4mg+Steroids+(CFZ, BTZ, CY or CLA), B: POM 3mg+PLD with or without steroids |
| PLDAlso: Pegylated liposomal doxirrubicin | Drug | B: POM 3mg+PLD with or without steroids |
| CFZAlso: Carfilzomib, Kyprolis | Drug | A: POM 4mg+Steroids+(CFZ, BTZ, CY or CLA) |
| BTZAlso: Bortezomib, Velcade | Drug | A: POM 4mg+Steroids+(CFZ, BTZ, CY or CLA) |
| CLAAlso: Clarithromycin | Drug | A: POM 4mg+Steroids+(CFZ, BTZ, CY or CLA) |
| CYAlso: Cyclophosphamide | Drug | A: POM 4mg+Steroids+(CFZ, BTZ, CY or CLA) |
Primary outcome
Maximum Tolerated Dose (MTD)
Time frame: Cycles 1-3 for selected regimens (up to 3 months)
MTD will be determined for any ≥ three-drug combinations other than: bortezomib + steroids + lenalidomide; carfilzomib + steroids + lenalidomide; clarithromycin + steroids + lenalidomide; cyclophosphamide + steroids + lenalidomide pegylated liposomal doxorubicin (PLD) + lenalidomide with or without steroids
Number of subjects with adverse events
Time frame: up to 36 months
Adverse events will be graded via the Common Terminology Criteria for Adverse Events (CTCAE) v 4.03 criteria.
Overall Response Rate
Time frame: up to 36 months
Overall response rate (ORR): complete response (CR)+ very good partial response (VGPR) + partial response (PR)
Clinical Benefit Rate (CBR)
Time frame: up to 36 months
CBR=ORR + minor response (MR)
5 secondary outcomes
Time to Progression
Time frame: time from initiation of therapy to progressive disease (assessed at least over 36 months)
Progression-free survival (PFS)
Time frame: time from initiation of therapy to progressive disease or death from any cause, whichever comes first (assessed at least over 36 months)
Time to first response (TTP)
Time frame: time from initiation of therapy to the first evidence of a confirmed response (up to 36 months)
Duration of response (DOR)
Time frame: time from the first response (> PR) to progressive disease (assessed at least over 36 months)
Overall survival (OS)
Time frame: time from initiation of therapy to death from any cause or last follow-up visit (assessed at least over 36 months).
Results and safety
The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James R Berenson, MD principal investigator
James R. Berenson MD, Inc.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing POM, Steroids and PLD in people with Multiple Myeloma, run by Oncotherapeutics at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) (time frame: Cycles 1-3 for selected regimens (up to 3 months)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2023.