Multiple MyelomaPhase 2NCT03567616
A Study of Venetoclax in Combination With Pomalidomide and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma
A Phase 2 study testing Venetoclax, Pomalidomide and Dexamethasone in people with Multiple Myeloma, run by AbbVie at 11 sites in 3 countries.
Trial summary
This was an open-label, multicenter study designed to evaluate the safety and preliminary efficacy of venetoclax combined with pomalidomide and dexamethasone in participants with relapsed or refractory (R/R) multiple myeloma (MM) who received at least 1 prior line of therapy with documented evidence of progression… 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?
- Venetoclax, Pomalidomide and Dexamethasone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 11 sitesin 3 countries
- Study dates
- 18 Oct 2018to 18 Jun 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Relapsed or refractory (R/R) multiple myeloma (MM) with documented evidence of progression during or after the participant's last treatment regimen
- Measurable disease as described in the protocol
- Received at least 1 prior line of therapy as described in the protocol
- Must meet prior antimyeloma treatment parameters, as described in the protocol, and includes:
- Received at least 2 consecutive cycles of lenalidomide or a lenalidomide-containing regimen
- Refractory to lenalidomide
Show all 14Show fewer
- Exposed to a proteasome inhibitor (PI) alone or in combination with another agent
- Had a response of partial response (PR) or better to prior therapy based on the investigator's determination of response as defined by International Myeloma Working Group (IMWG) criteria
- Has t(11;14) status as described in the protocol and meets the following criteria:
- For Part 1: MM participants independent of cytogenetic profile
- For Part 2, Arm A: participant must be t(11;14) positive
- For Part 2, Arm B: participant must be t(11;14) negative
- An Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Adequate kidney, liver and hematologic laboratory values
Who cannot join
- Previous treatment with venetoclax or other BCL-2 inhibitors, or previous treatment with pomalidomide
- Known sensitivity to any IMiDs
- Allogenic or syngeneic stem cell transplant within 6 months before the first dose of study drug or active ongoing graft versus host disease
- Autologous stem cell transplant within 12 weeks before the first dose of study drug
- Known meningeal involvement of MM
Trial locations and contacts
11 sites in 3 countries.
11 sites in 3 countries
United States5 sites
John B. Amos Cancer Center - C /ID# 202055
Columbus, Georgia, 31904
Ohio State Cancer Center /ID# 202443
Columbus, Ohio, 43210
Duke University Hospital /ID# 200805
Durham, North Carolina, 27710
University of Kansas Cancer Center /ID# 201292
Fairway, Kansas, 66205-2528
Washington University-School of Medicine /ID# 201287
St Louis, Missouri, 63110
Spain3 sites
Hospital Universitario Germans Trias i Pujol /ID# 200959
Badalona, Barcelona, 08916
Hospital Universitario Vall d'Hebron /ID# 200967
Barcelona, 08035
Hospital Clinico Universitario de Salamanca /ID# 200958
Salamanca, 37007
United Kingdom3 sites
Univ Hospitals Birmingham NHS Foundation trust /ID# 203188
Birmingham, B15 2TG
Leicester Royal Infirmary /ID# 202238
Leicester, England, LE1 5WW
Norfolk and Norwich Univ Hosp /ID# 202240
Norwich, Norfolk, NR4 7UY
About this study
Official title: A Phase 2, Open-Label, Multicenter, Dose-Escalation and Expansion Study of Venetoclax in Combination With Pomalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
This was an open-label, multicenter study designed to evaluate the safety and preliminary efficacy of venetoclax combined with pomalidomide and dexamethasone in participants with relapsed or refractory (R/R) multiple myeloma (MM) who received at least 1 prior line of therapy with documented evidence of progression during or after the participant's last treatment regimen. The study was designed to consist of 2 parts: Part 1 (dose escalation) and Part 2 (dose expansion). For Part 2 the participants were to be divided into 2 cohorts, participants positive for t(11;14) translocation and participants negative for t(11;14) translocation.
Read the detailed description
Following communication of the results of the primary progression-free survival (PFS) analysis from the Phase 3 BELLINI study (Study M14-031; NCT02755597), the company-sponsored MM studies were placed on partial clinical hold (PCH) in March 2019 by the United States (US) Food and Drug Administration and enrollment was halted. The sponsor did not pursue release of the PCH for this study; therefore, enrollment was not re-opened. In accordance with the terms of the PCH, participants who were deriving clinical benefit were allowed to continue to receive treatment. One participant was still active in Part 1 of the study when the sponsor decided not to pursue release of the PCH (in January 2020) and, therefore, continued to receive treatment and have regular assessments until disease progression. The study was discontinued when the last participant completed study treatment. No participants were enrolled in Part 2 of the study.
- Conditions
- Multiple Myeloma
- Being tested
- Venetoclax, Pomalidomide, Dexamethasone
- Keywords
- Cancer, Multiple Myeloma (MM), Relapsed or Refractory (R/R), Venetoclax, Pomalidomide, Dexamethasone
- Medical subject headings
- Multiple Myeloma, Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VenetoclaxDrug
Also called ABT-199, GDC-0199, Venclexta
Tablet; oral
PomalidomideDrug
Also called Pomalyst
Capsule; oral
DexamethasoneDrug
Administered orally; for participants over 75 years of age, dexamethasone could have been administered at a 20 mg dose [qw]
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Dose Escalation | Experimental | Venetoclax (400 mg oral [PO], once daily [QD]) administered with pomalidomide (4 mg PO, QD) and dexamethasone (40 mg once weekly [qw]) in 28-day cycles until documented disease progression, documented unacceptable toxicity, withdrawal of consent, or the participant met other criteria for discontinuation per study protocol Receives: Drug: Venetoclax; Drug: Pomalidomide; Drug: Dexamethasone |
| Part 2: Dose Expansion, t(11;14) positive | Experimental | Participants positive for t(11;14) translocation were to receive the venetoclax dose determined to be safe in Part 1 as well as pomalidomide (4 mg oral [PO], once daily [QD]) and dexamethasone (40 mg once weekly [qw]) Receives: Drug: Venetoclax; Drug: Pomalidomide; Drug: Dexamethasone |
| Part 2: Dose Expansion, t(11;14) negative | Experimental | Participants negative for t(11;14) translocation were to receive the venetoclax dose determined to be safe in Part 1 as well as pomalidomide (4 mg oral [PO], once daily [QD]) and dexamethasone (40 mg once weekly [qw]) Receives: Drug: Venetoclax; Drug: Pomalidomide; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either reasonable possibility or no reasonable possibility. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.
Measured: From first dose of study drug until 30 days following last dose of study drug (up to 70 weeks)
Overall Response Rate (ORR)
ORR is defined as the percentage of participants experiencing a stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) using the International Myeloma Working Group (IMWG) 2016 criteria for disease response and progression. CR= negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas, and < 5% plasma cells in bone marrow; sCR= CR + normal serum free light chain (FLC) ratio and absence of clonal cells in bone marrow; VGPR= serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein level + urine M-protein level < 100 mg per 24 hours; PR= ≥ 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥ 90% or to < 200 mg per 24 hours.
Measured: Approximately 15 months
Secondary outcomes (3)
Progression-Free Survival (PFS)
PFS is defined as the number of days from the date of first dose of any study drug to the date of disease progression or death, whichever occurs first. All disease progression was to be included regardless of whether the event occurred during or after the participant was taking any study drug.
Measured: Approximately 20 months
Duration of Response (DOR)
DOR for a given participant is defined as the number of days from the date of that participant's first documented response (Partial Response [PR] or better) to the date of first documented disease progression (PD) or death due to multiple myeloma (MM), whichever occurs first. If the participant with a documented response did not have an event of PD and the participant had not died due to MM, the participant's data was to be censored.
Measured: Approximately 15 months
Time-to-progression (TTP)
TTP for a given participant is defined as the number of days from the date of first dose to the date of first documented disease progression (PD) or death due to multiple myeloma (MM), whichever occurs first. If the participant did not have an event of PD and the participant had not died due to MM, the participant's data was to be censored.
Measured: Approximately 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start18 Oct 2018
- Primary completion18 Jun 2020
- Study completion18 Jun 2020
Why it stopped: Following results of the primary progression-free survival analysis from Study NCT02755597, company-sponsored MM studies were placed on partial clinical hold (PCH). Sponsor did not pursue release of the PCH for this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03567616
- Sponsor's protocol ID
- M16-085
- Other IDs
- 2017-004232-11, 2017
- Status last verified
- Jun 2021
- First submitted
- 12 Jun 2018
- Last updated
- 30 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
- Expanded access
- Available
Publications
Gasparetto C, Bowles KM, Abdallah AO, Morris L, Mander G, Coppola S, Wang J, Ross JA, Bueno OF, Arriola E, Mateos MV. A Phase II Study of Venetoclax in Combination With Pomalidomide and Dexamethasone in Relapsed/Refractory Multiple Myeloma. Clin Lymphoma Myeloma Leuk. 2021 Nov;21(11):775-784. doi: 10.1016/j.clml.2021.07.029. Epub 2021 Aug 1.
PubMed 34551886
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-Label, Multicenter, Dose-Escalation and Expansion Study of Venetoclax in Combination With Pomalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT03567616
- Acronym / sponsor ID
- M16-085
- Conditions
- Multiple Myeloma
- Keywords
- Cancer, Multiple Myeloma (MM), Relapsed or Refractory (R/R), Venetoclax, Pomalidomide, Dexamethasone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Following results of the primary progression-free survival analysis from Study NCT02755597, company-sponsored MM studies were placed on partial clinical hold (PCH). Sponsor did not pursue release of the PCH for this study.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Collaborators
- Celgene
- Study start
- 18 Oct 2018 (actual)
- Primary completion
- 18 Jun 2020 (actual)
- Study completion
- 18 Jun 2020 (actual)
- First posted
- 26 Jun 2018 (actual)
- Results
- Posted 30 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was an open-label, multicenter study designed to evaluate the safety and preliminary efficacy of venetoclax combined with pomalidomide and dexamethasone in participants with relapsed or refractory (R/R) multiple myeloma (MM) who received at least 1 prior line of therapy with documented evidence of progression during or after the participant's last treatment regimen. The study was designed to consist of 2 parts: Part 1 (dose escalation) and Part 2 (dose expansion). For Part 2 the participants were to be divided into 2 cohorts, participants positive for t(11;14) translocation and participants negative for t(11;14) translocation.
Detailed description
Following communication of the results of the primary progression-free survival (PFS) analysis from the Phase 3 BELLINI study (Study M14-031; NCT02755597), the company-sponsored MM studies were placed on partial clinical hold (PCH) in March 2019 by the United States (US) Food and Drug Administration and enrollment was halted. The sponsor did not pursue release of the PCH for this study; therefore, enrollment was not re-opened. In accordance with the terms of the PCH, participants who were deriving clinical benefit were allowed to continue to receive treatment. One participant was still active in Part 1 of the study when the sponsor decided not to pursue release of the PCH (in January 2020) and, therefore, continued to receive treatment and have regular assessments until disease progression. The study was discontinued when the last participant completed study treatment. No participants were enrolled in Part 2 of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1: Dose Escalation | Experimental | Drug: Venetoclax, Drug: Pomalidomide, Drug: DexamethasoneVenetoclax (400 mg oral [PO], once daily [QD]) administered with pomalidomide (4 mg PO, QD) and dexamethasone (40 mg once weekly [qw]) in 28-day cycles until documented disease progression, documented unacceptable toxicity, withdrawal of consent, or the participant met other criteria for discontinuation per study protocol |
| Part 2: Dose Expansion, t(11;14) positive | Experimental | Drug: Venetoclax, Drug: Pomalidomide, Drug: DexamethasoneParticipants positive for t(11;14) translocation were to receive the venetoclax dose determined to be safe in Part 1 as well as pomalidomide (4 mg oral [PO], once daily [QD]) and dexamethasone (40 mg once weekly [qw]) |
| Part 2: Dose Expansion, t(11;14) negative | Experimental | Drug: Venetoclax, Drug: Pomalidomide, Drug: DexamethasoneParticipants negative for t(11;14) translocation were to receive the venetoclax dose determined to be safe in Part 1 as well as pomalidomide (4 mg oral [PO], once daily [QD]) and dexamethasone (40 mg once weekly [qw]) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Relapsed or refractory (R/R) multiple myeloma (MM) with documented evidence of progression during or after the participant's last treatment regimen
- Measurable disease as described in the protocol
- Received at least 1 prior line of therapy as described in the protocol
- Must meet prior antimyeloma treatment parameters, as described in the protocol, and includes:
- Received at least 2 consecutive cycles of lenalidomide or a lenalidomide-containing regimen
Key exclusion criteria (5 listed)
- Previous treatment with venetoclax or other BCL-2 inhibitors, or previous treatment with pomalidomide
- Known sensitivity to any IMiDs
- Allogenic or syngeneic stem cell transplant within 6 months before the first dose of study drug or active ongoing graft versus host disease
- Autologous stem cell transplant within 12 weeks before the first dose of study drug
- Known meningeal involvement of MM
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 |
|---|---|---|
| VenetoclaxAlso: ABT-199, GDC-0199, VenclextaTablet; oral | Drug | Part 1: Dose Escalation, Part 2: Dose Expansion, t(11;14) negative, Part 2: Dose Expansion, t(11;14) positive |
| PomalidomideAlso: PomalystCapsule; oral | Drug | Part 1: Dose Escalation, Part 2: Dose Expansion, t(11;14) negative, Part 2: Dose Expansion, t(11;14) positive |
| DexamethasoneAdministered orally; for participants over 75 years of age, dexamethasone could have been administered at a 20 mg dose [qw] | Drug | Part 1: Dose Escalation, Part 2: Dose Expansion, t(11;14) negative, Part 2: Dose Expansion, t(11;14) positive |
Primary outcome
Number of Participants With Adverse Events
Time frame: From first dose of study drug until 30 days following last dose of study drug (up to 70 weeks)
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either reasonable possibility or no reasonable possibility. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.
Overall Response Rate (ORR)
Time frame: Approximately 15 months
ORR is defined as the percentage of participants experiencing a stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) using the International Myeloma Working Group (IMWG) 2016 criteria for disease response and progression. CR= negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas, and < 5% plasma cells in bone marrow; sCR= CR + normal serum free light chain (FLC) ratio and absence of clonal cells in bone marrow; VGPR= serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein level + urine M-protein level < 100 mg per 24 hours; PR= ≥ 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥ 90% or to < 200 mg per 24 hours.
3 secondary outcomes
Progression-Free Survival (PFS)
Time frame: Approximately 20 months
Duration of Response (DOR)
Time frame: Approximately 15 months
Time-to-progression (TTP)
Time frame: Approximately 15 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34551886Gasparetto C, Bowles KM, Abdallah AO, Morris L, Mander G, Coppola S, Wang J, Ross JA, Bueno OF, Arriola E, Mateos MV. A Phase II Study of Venetoclax in Combination With Pomalidomide and Dexamethasone in Relapsed/Refractory Multiple Myeloma. Clin Lymphoma Myeloma Leuk. 2021 Nov;21(11):775-784. doi: 10.1016/j.clml.2021.07.029. Epub 2021 Aug 1.
- This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
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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.
AbbVie Inc. study director
AbbVie
11 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Venetoclax, Pomalidomide and Dexamethasone in people with Multiple Myeloma, run by AbbVie at 11 sites in 3 countries.
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 14 inclusion and 5 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 30 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Spain, United Kingdom. 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?
Yes. Results are posted in the registry (first posted 30 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Adverse Events (time frame: From first dose of study drug until 30 days following last dose of study drug (up to 70 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03567616, which also lists 1 linked publication.
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 30 Jun 2021.