Multiple MyelomaPhase 1NCT02462525
Dose-Escalation Study of ABBV-838, an Antibody Drug Conjugate, in Subjects With Relapsed and Refractory Multiple Myeloma
A Phase 1 study testing ABBV-838, Pomalidomide and Dexamethasone in people with Multiple Myeloma, run by AbbVie at 19 sites in 4 countries.
Trial summary
This is a Phase 1/1b, open-label, dose-escalation study designed to evaluate the safety, pharmacokinetics, and to determine the recommended Phase 2 dose of ABBV-838 in subjects with relapsed and refractory multiple myeloma. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- ABBV-838, Pomalidomide and Dexamethasone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 19 sitesin 4 countries
- Study dates
- 6 May 2015to 6 Dec 2017
- Phase
- Phase 1
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eastern Cooperative Oncology Group Performance Status of 0 to 2
- Not eligible for stem cell/bone marrow transplant or have refused stem cell/bone marrow transplant or have relapsed after autologous or allogeneic stem cell/bone marrow transplant
- Eligible for and agree to BM aspirate prior to treatment start
- Measurable disease M component in serum (≥ 0.5 g/dL) and/or urine (≥ 0.2 g excreted in a 24 hour collection sample)
- Must have received at least 3 prior lines of therapy including a proteasome inhibitor and an immunomodulatory agent or those who are double refractory to a PI and an immunomodulatory agent and have demonstrated disease progression (DP) on or within 60 days of completion of the last therapy; participants previously treated with an alkylating agent, in addition to an IMiD or proteasome inhibitor, are allowed to enroll in the trial
- Participants must have adequate liver, kidney, and bone morrow function
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- Participants with a history of chronic heart failure must have cardiac ECHO indicating left ventricular ejection fraction (LVEF) ≥ 45% within 21 days prior to first dose of study drug
- Participants in the combination therapy arms must be eligible to receive pomalidomide/dexamethasone, bortezomib/dexamethasone or lenalidomide/dexamethasone or other approved agents per current prescribing information for MM.
- Participants who will receive combination therapy with Pomalidomide/Dexamethasone must have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy
Who cannot join
- Received anti-cancer therapy including chemotherapy, immunotherapy, radiation, biologic, any investigational therapy or herbal therapy within a period of 21 days prior to the first dose of ABBV-838, and have unresolved toxicities ≥ grade 2
- Concurrent metastatic solid tumors
- Non-Measurable M Protein (serum or urine) and measurable sFLC (< 100 mg/mL)
- Major surgery within 21 days prior to the first dose of ABBV-838
- Clinically significant uncontrolled condition(s) including but not limited to the following:
- Grade ≥ 3 peripheral neuropathy or grade 2 peripheral neuropathy with pain Uncontrolled hypercalcemia Active uncontrolled infection Symptomatic congestive heart failure Unstable angina pectoris or cardiac arrhythmia Psychiatric illness/social situation that would limit compliance with the study
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- Major immunologic reaction to any IgG containing agent or auristatin based agent
- Participants who are taking strong CYP3A4 inhibitors
- Positive for HIV (Human Immunodeficiency Virus) or with active hepatitis B and/or C
- Corneal pathology that would limit evaluation of loss in visual acuity associated with corneal deposits.
- Prior exposure to pomalidomide for subjects enrolling in the pomalidomide/dexamethasone combination arm.
Trial locations and contacts
19 sites in 4 countries.
19 sites in 4 countries
Germany6 sites
Universitaetsklinikum Koeln /ID# 141535
Cologne, 50937
Universitaetklinikum Dresden /ID# 141860
Dresden, 01307
Universitaetsklinikum Heidelberg /ID# 140046
Heidelberg, 69210
Universitaetsklinikum Schleswig-Holstein /ID# 141534
Kiel, 24105
Universitaetsklinikum Tuebingen /ID# 141074
Tübingen, 72076
Universitaetsklinikum Wuerzburg /ID# 141533
Würzburg, 97080
United States5 sites
University of Michigan Medical Center /ID# 139402
Ann Arbor, Michigan, 48109
The University of Chicago Medical Center /ID# 139403
Chicago, Illinois, 60637
The Sarah Cannon Research Institute /ID# 135814
Nashville, Tennessee, 37203
Mount Sinai Medical Center /ID# 133569
New York, New York, 10029
Washington University School of Medicine /ID# 135708
St Louis, Missouri, 63110-1093
Spain5 sites
Hospital Clinic de Barcelona /ID# 141643
Barcelona, 08036
Hospital Universitario de la Princesa /ID# 140881
Madrid, 28006
Hospital Universitario 12 de Octubre /ID# 140878
Madrid, 28041
Clinica Universitaria de Navarra /ID# 141411
Pamplona-Navarra, 31008
Hospital Clinico Universitario Salamanca /ID# 140880
Salamanca, 37007
France3 sites
CHRU de Lille, Hopital Claude Huriez /ID# 133634
Lille, 59037
CHU de Nantes, Hotel Dieu - HME /ID# 133633
Nantes, 44093
CHU de la miletrie, Centre d'investigation clinique /ID# 147542
Poitiers, 86021
About this study
Official title: A Multicenter, Phase 1/1b, Open-Label, Dose-Escalation Study of ABBV-838, an Antibody Drug Conjugate, in Subjects With Relapsed and Refractory Multiple Myeloma
This is a Phase 1/1b, open-label, dose-escalation study designed to evaluate the safety, pharmacokinetics, and to determine the recommended Phase 2 dose of ABBV-838 in subjects with relapsed and refractory multiple myeloma.
- Conditions
- Multiple Myeloma
- Being tested
- ABBV-838, Pomalidomide, Dexamethasone
- Keywords
- relapsed multiple myeloma, antibody drug conjugate, 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.
ABBV-838Drug
Varying doses of ABBV-838
PomalidomideDrug
Administered orally per the label.
DexamethasoneDrug
Administered orally per the label.
| Study group | Role | What they receive |
|---|---|---|
| ABBV-838 dose escalation | Experimental | Varying doses of ABBV-838 Receives: Drug: ABBV-838 |
| ABBV-838 plus pomalidomide/dexamethasone | Experimental | ABBV-838 to be evaluated with pomalidomide/dexamethasone. Receives: Drug: ABBV-838; Drug: Pomalidomide; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration (Cmax) of ABBV-838
The maximum plasma concentration (Cmax: measured in ng/ml) is the highest concentration that a drug achieves in the blood after the first dose, but before administration of a second dose.
Measured: Cycle 1 Day 1 (C1D1) and C3D1 pre- and post-dose; C1D4, C1D8, C1D15, C2D1, C2D15, C3D4, C3D8, C3D15, C4D1, and all subsequent ABBV-838 pre-dose dosing cycles
Maximum tolerated dose of ABBV-838
The highest dose level at which less than 2 of 6 subjects or less than 33% of (if cohort is expanded beyond 6) subjects experience a dose limiting toxicity.
Measured: Up to 2 years from first dose of study
Secondary outcomes (1)
Preliminary activity of ABBV-838 monotherapy
Response evaluation will be based on International Myeloma Working Group (IMWG) Response Criteria.
Measured: At screening, Cycle 1 Day 15 (C1D15), C3D15, C4D1, and for subjects who have been on ABBV-838 for ≥ 6 cycles, radiologic tumor assessments may be performed every 3 cycles per Investigator discretion up to approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2015 (estimated)
- Study start6 May 2015
- Primary completion6 Dec 2017
- Study completion6 Dec 2017
Why it stopped: No Go decision for ABBV-838
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- AbbVie Inc., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02462525
- Sponsor's protocol ID
- M14-467
- Other IDs
- 2014-002609-39, 2014
- Status last verified
- Sep 2018
- First submitted
- 26 May 2015
- Last updated
- 13 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Vij R, Nath R, Afar DEH, Mateos MV, Berdeja JG, Raab MS, Guenther A, Martinez-Lopez J, Jakubowiak AJ, Leleu X, Weisel K, Wong S, Gulbranson S, Sheridan JP, Reddy A, Paiva B, Singhal A, San-Miguel JF, Moreau P. First-in-Human Phase I Study of ABBV-838, an Antibody-Drug Conjugate Targeting SLAMF7/CS1 in Patients with Relapsed and Refractory Multiple Myeloma. Clin Cancer Res. 2020 May 15;26(10):2308-2317. doi: 10.1158/1078-0432.CCR-19-1431. Epub 2020 Jan 22.
PubMed 31969330
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Phase 1/1b, Open-Label, Dose-Escalation Study of ABBV-838, an Antibody Drug Conjugate, in Subjects With Relapsed and Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT02462525
- Acronym / sponsor ID
- M14-467
- Conditions
- Multiple Myeloma
- Keywords
- relapsed multiple myeloma, antibody drug conjugate, refractory multiple myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No Go decision for ABBV-838
- Enrolment
- 74 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 6 May 2015 (actual)
- Primary completion
- 6 Dec 2017 (actual)
- Study completion
- 6 Dec 2017 (actual)
- First posted
- 4 Jun 2015 (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.
This is a Phase 1/1b, open-label, dose-escalation study designed to evaluate the safety, pharmacokinetics, and to determine the recommended Phase 2 dose of ABBV-838 in subjects with relapsed and refractory multiple myeloma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ABBV-838 dose escalation | Experimental | Drug: ABBV-838Varying doses of ABBV-838 |
| ABBV-838 plus pomalidomide/dexamethasone | Experimental | Drug: ABBV-838, Drug: Pomalidomide, Drug: DexamethasoneABBV-838 to be evaluated with pomalidomide/dexamethasone. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Eastern Cooperative Oncology Group Performance Status of 0 to 2
- Not eligible for stem cell/bone marrow transplant or have refused stem cell/bone marrow transplant or have relapsed after autologous or allogeneic stem cell/bone marrow transplant
- Eligible for and agree to BM aspirate prior to treatment start
- Measurable disease M component in serum (≥ 0.5 g/dL) and/or urine (≥ 0.2 g excreted in a 24 hour collection sample)
- Must have received at least 3 prior lines of therapy including a proteasome inhibitor and an immunomodulatory agent or those who are double refractory to a PI and an immunomodulatory agent and have demonstrated disease progression (DP) on or within 60 days of completion of the last therapy; participants previously treated with an alkylating agent, in addition to an IMiD or proteasome inhibitor, are allowed to enroll in the trial
Key exclusion criteria (11 listed)
- Received anti-cancer therapy including chemotherapy, immunotherapy, radiation, biologic, any investigational therapy or herbal therapy within a period of 21 days prior to the first dose of ABBV-838, and have unresolved toxicities ≥ grade 2
- Concurrent metastatic solid tumors
- Non-Measurable M Protein (serum or urine) and measurable sFLC (< 100 mg/mL)
- Major surgery within 21 days prior to the first dose of ABBV-838
- Clinically significant uncontrolled condition(s) including but not limited to the following:
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 |
|---|---|---|
| ABBV-838Varying doses of ABBV-838 | Drug | ABBV-838 dose escalation, ABBV-838 plus pomalidomide/dexamethasone |
| PomalidomideAdministered orally per the label. | Drug | ABBV-838 plus pomalidomide/dexamethasone |
| DexamethasoneAdministered orally per the label. | Drug | ABBV-838 plus pomalidomide/dexamethasone |
Primary outcome
Maximum plasma concentration (Cmax) of ABBV-838
Time frame: Cycle 1 Day 1 (C1D1) and C3D1 pre- and post-dose; C1D4, C1D8, C1D15, C2D1, C2D15, C3D4, C3D8, C3D15, C4D1, and all subsequent ABBV-838 pre-dose dosing cycles
The maximum plasma concentration (Cmax: measured in ng/ml) is the highest concentration that a drug achieves in the blood after the first dose, but before administration of a second dose.
Maximum tolerated dose of ABBV-838
Time frame: Up to 2 years from first dose of study
The highest dose level at which less than 2 of 6 subjects or less than 33% of (if cohort is expanded beyond 6) subjects experience a dose limiting toxicity.
1 secondary outcome
Preliminary activity of ABBV-838 monotherapy
Time frame: At screening, Cycle 1 Day 15 (C1D15), C3D15, C4D1, and for subjects who have been on ABBV-838 for ≥ 6 cycles, radiologic tumor assessments may be performed every 3 cycles per Investigator discretion up to approximately 3 years
Results and safety
The study was stopped early (reason given: No Go decision for ABBV-838). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2018.
- Derived from this study: PubMed 31969330Vij R, Nath R, Afar DEH, Mateos MV, Berdeja JG, Raab MS, Guenther A, Martinez-Lopez J, Jakubowiak AJ, Leleu X, Weisel K, Wong S, Gulbranson S, Sheridan JP, Reddy A, Paiva B, Singhal A, San-Miguel JF, Moreau P. First-in-Human Phase I Study of ABBV-838, an Antibody-Drug Conjugate Targeting SLAMF7/CS1 in Patients with Relapsed and Refractory Multiple Myeloma. Clin Cancer Res. 2020 May 15;26(10):2308-2317. doi: 10.1158/1078-0432.CCR-19-1431. Epub 2020 Jan 22.
- Individual participant dataSharing planned: Undecided
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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
19 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABBV-838, Pomalidomide and Dexamethasone in people with Multiple Myeloma, run by AbbVie at 19 sites in 4 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 9 inclusion and 11 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 13 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Germany, United States, Spain, France. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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: No Go decision for ABBV-838). 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 plasma concentration (Cmax) of ABBV-838 (time frame: Cycle 1 Day 1 (C1D1) and C3D1 pre- and post-dose; C1D4, C1D8, C1D15, C2D1, C2D15, C3D4, C3D8, C3D15, C4D1, and all subsequent ABBV-838 pre-dose dosing cycles). 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 NCT02462525, 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 13 Sep 2018.