Multiple MyelomaPhase 1/2NCT06953960
A Study to Assess Adverse Events and Change in Disease Activity of Oral Surzetoclax Alone or in Combination With Subcutaneous and/or Oral Antimyeloma Agents in Adult Participants With Multiple Myeloma (MM)
A Phase 1/2 study testing Surzetoclax, Daratumumab and Dexamethasone in people with Multiple Myeloma, run by AbbVie at 50 sites in 12 countries.
Trial summary
Multiple myeloma (MM) is a plasma cell disease characterized by the growth of clonal plasma cells in the bone marrow. The purpose of this study is to assess the safety and change in disease activity of surzetoclax in adult participants with relapsed/refractory (R/R) MM. 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?
- Surzetoclax, Daratumumab and Dexamethasone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 325 participants
- Where
- 50 sitesin 12 countries
- Study dates
- 23 Jul 2025to Dec 2030
- Phase
- Phase 1/2
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
- Documented diagnosis of multiple myeloma (MM) based on standard international myeloma working group (IMWG) diagnostic criteria.
- All participants must have measurable disease per central laboratory with at least 1 of the following assessed within 28 days prior to enrollment:
- Serum M-protein >= 0.5 g/dL (>= 5g/L); OR
- Urine M-protein >= 200 mg/24 hours; OR
- For participants without measurable serum and urine M-protein: Serum free light chain (sFLC) >= 10 mg/dL (100 mg/L), provided sFLC ratio is abnormal.
- B-cell lymphoma (BCL)-2 inhibitor treatment naïve.
- t(11;14) positive status and/or BCL2 high status.
- Must have confirmed diagnosis of relapsed or refractory (R/R) multiple myeloma (MM) with documented evidence of progression during or after the participant's last treatment regimen, based on the investigator's determination of the international myeloma working group (IMWG) 2016 criteria.
Who cannot join
- Major surgery within 4 weeks of study treatment or planned during study participation.
- Recent infection requiring systemic treatment that was completed <= 14 days before first dose of study treatment and/or uncontrolled active systemic infection.
Trial locations and contacts
50 sites in 12 countries. Contact the study team or a site near you to ask about taking part.
50 sites in 12 countries
United States12 sites, 12 recruiting
- Recruiting
University of Michigan Health System - Ann Arbor /ID# 271536
Ann Arbor, Michigan, 48109
- Recruiting
Dana-Farber Cancer Institute /ID# 271846
Boston, Massachusetts, 02215
- Recruiting
Atrium Health Levine Cancer Institute /ID# 271510
Charlotte, North Carolina, 28204
- Recruiting
University of Texas - Southwestern Medical Center /ID# 271914
Dallas, Texas, 75235
- Recruiting
University Of North Carolina Health Care - Hillsborough Campus /ID# 272454
Hillsborough, North Carolina, 27278
- Recruiting
University of Southern California /ID# 272414
Los Angeles, California, 90033
- Recruiting
Yale University School of Medicine /ID# 272447
New Haven, Connecticut, 06510
- Recruiting
Memorial Sloan Kettering Cancer Center - New York - York Avenue /ID# 271214
New York, New York, 10065
- Recruiting
Oregon Health and Science University /ID# 272282
Portland, Oregon, 97239
- Recruiting
Huntsman Cancer Institute /ID# 271618
Salt Lake City, Utah, 84112
- Recruiting
Northwest Medical Specialties Tacoma /ID# 272506
Tacoma, Washington, 98405
- Recruiting
Atrium Health Wake Forest Baptist Medical Center /ID# 271294
Winston-Salem, North Carolina, 27157
France5 sites, 5 recruiting
- Recruiting
CHU de Montpellier - Hopital Saint Eloi /ID# 275570
Montpellier, Herault, 34295
- Recruiting
Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 275562
Nantes, Pays de la Loire Region, 44000
- Recruiting
Hopital Universitaire Necker Enfants Malades /ID# 275571
Paris, Île-de-France Region, 75015
- Recruiting
Centre Hospitalier Universitaire de Poitiers /ID# 275563
Poitiers, New Aquitaine, 86021
- Recruiting
IUCT Oncopole /ID# 275568
Toulouse, Occitanie, 31059
Israel5 sites, 5 recruiting
- Recruiting
Rambam Health Care Campus- Haifa /ID# 271256
Haifa, 3109601
- Recruiting
Hadassah Medical Center-Hebrew University /ID# 271253
Jerusalem, 91120
- Recruiting
Rabin Medical Center. /ID# 272073
Petah Tikva, Central District, 4941492
- Recruiting
The Chaim Sheba Medical Center /ID# 271251
Ramat Gan, Tel Aviv, 5265601
- Recruiting
Tel Aviv Sourasky Medical Center /ID# 271252
Tel Aviv, Tel Aviv, 6423906
Japan5 sites, 5 recruiting
- Recruiting
University Hospital Kyoto Prefectural University of Medicine /ID# 271911
Kyoto, Kyoto, 602-8566
- Recruiting
Nagoya City University Hospital /ID# 271427
Nagoya, Aichi-ken, 467-8602
- Recruiting
Japanese Red Cross Medical Center /ID# 272018
Shibuya-ku, Tokyo, 150-8935
- Recruiting
The University of Osaka Hospital /ID# 271636
Suita-shi, Osaka, 565-0871
- Recruiting
The Jikei University Hospital /ID# 272091
Tokyo, 105-8461
Australia4 sites, 4 recruiting
- Recruiting
St Vincent's Hospital - Melbourne /ID# 271997
Fitzroy, Victoria, 3065
- Recruiting
Liverpool Hospital /ID# 272002
Liverpool, New South Wales, 2170
- Recruiting
Epworth HealthCare /ID# 272497
Richmond, Victoria, 3121
- Recruiting
Calvary Mater Newcastle /ID# 272498
Waratah, New South Wales, 2298
Germany4 sites, 4 recruiting
- Recruiting
Universitaetsklinikum Hamburg-Eppendorf /ID# 275803
Hamburg, 20246
- Recruiting
Universitaetsklinikum Heidelberg /ID# 275598
Heidelberg, Baden-Wurttemberg, 69120
- Recruiting
Klinikum der Universitaet Muenchen Grosshadern /ID# 276658
Munich, Bavaria, 81337
- Recruiting
Universitaetsklinikum Wuerzburg /ID# 276657
Würzburg, Bavaria, 97080
Poland4 sites, 4 recruiting
- Recruiting
Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie /ID# 276052
Lublin, Lublin Voivodeship, 20-081
- Recruiting
Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie /ID# 276352
Lublin, Lublin Voivodeship, 20-090
- Recruiting
Uniwersytecki Szpital Kliniczny w Poznaniu - Szamarzewskiego /ID# 276237
Poznan, Greater Poland Voivodeship, 60-569
- Recruiting
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Bada /ID# 276263
Warsaw, Masovian Voivodeship, 02-781
Belgium3 sites, 3 recruiting
- Recruiting
UZ Gent /ID# 271432
Ghent, Oost-Vlaanderen, 9000
- Recruiting
Universitair Ziekenhuis Leuven /ID# 272382
Leuven, Vlaams-Brabant, 3000
- Recruiting
CHU de Liege /ID# 271430
Liège, 4000
Portugal3 sites, 3 recruiting
- Recruiting
Unidade Local de Saude de Braga, EPE /ID# 275853
Braga, 4710-243
- Recruiting
Instituto Portugues de Oncologia de Lisboa Francisco Gentil /ID# 275873
Lisbon, Lisbon District, 1099-023
- Recruiting
Instituto Portugues de Oncologia do Porto Francisco Gentil /ID# 275851
Porto, 4200-072
Sweden3 sites, 3 recruiting
- Recruiting
Sodra Alvsborgs sjukhus /ID# 271822
Borås, Västra Götaland County, 501 82
- Recruiting
Sahlgrenska Universitetssjukhuset /ID# 272448
Gothenburg, Västra Götaland County, 413 46
- Recruiting
Karolinska Universitetssjukhuset - Huddinge /ID# 271674
Huddinge, Stockholm County, 141 57
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 276306
Milan, 20122
United Kingdom1 site, 1 recruiting
- Recruiting
The Christie NHS Foundation Trust - Christie Hospital /ID# 276276
Manchester, M20 4BX
About this study
Official title: A Phase 1/2, Open-Label, Platform Study to Evaluate Safety and Efficacy of the BCL-2 Inhibitor Surzetoclax (ABBV-453) Given as Monotherapy or in Combination With Antimyeloma Regimens in Subjects With Multiple Myeloma
Multiple myeloma (MM) is a plasma cell disease characterized by the growth of clonal plasma cells in the bone marrow. The purpose of this study is to assess the safety and change in disease activity of surzetoclax in adult participants with relapsed/refractory (R/R) MM. Adverse events and change in disease activity will be assessed.
Surzetoclax is an investigational drug being developed for the treatment of R/R MM. In Substudy 1 there will be dose escalation and dose expansion phases where participants will receive various doses (escalation) or 1 of 2 doses (expansion) of surzetoclax in combination with daratumumab + dexamethasone, to determine the best dose of surzetoclax. In Substudy 2, there will be a dose escalation phase where participants will receive various doses of surzetoclax alone. In Substudy 3 there will be dose escalation and optimization phases where participants will receive various doses (escalation) or 1 of 2 doses (optimization) of of surzetoclax and etentamig to determine the best dose of surzetoclax and etentamig. Optimization will also include etentamig received alone. Approximately 325 adult participants with R/R MM will be enrolled in the study in approximately 55 sites worldwide.
Read more
In Substudy 1 escalation phase, participants will receive oral surzetoclax tablets in combination with subcutaneous (SC) daratumumab injections + oral dexamethasone tablets and in the expansion phase, will receive 1 of 2 doses oral surzetoclax tablets in combination with SC daratumumab injections + oral dexamethasone tablets or daratumumab injections + oral pomalidomide + oral dexamethasone tablets. In Substudy 2, Japanese participants will receive oral surzetoclax tablets. In Substudy 3 escalation phase, participants will receive oral surzetoclax tablets in combination with IV etentamig and in the expansion phase, will receive 1 of 2 doses of both oral surzetoclax tablets in combination with of IV etentamig, or IV etentamig alone. The total study duration is approximately 4.5 years.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution. The effect of the treatment will be frequently checked by medical assessments, blood tests, and side effects.
- Conditions
- Multiple Myeloma
- Being tested
- Surzetoclax, Daratumumab, Dexamethasone, Pomalidomide, Etentamig
- Keywords
- Multiple Myeloma, ABBV-453, Surzetoclax, Daratumumab, Dexamethasone, Pomalidomide, Cancer
- Medical subject headings
- Multiple Myeloma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurzetoclaxDrug
Oral
DaratumumabDrug
Subcutaneous (SC) Injection
DexamethasoneDrug
Oral
PomalidomideDrug
Oral
EtentamigDrug
Intravenous Infusion
| Study group | Role | What they receive |
|---|---|---|
| Substudy 1: Dose Escalation Surzetoclax Combination | Experimental | Participants will receive various doses of surzetoclax in combination with daratumumab + dexamethasone, to determine the best dose of surzetoclax, as part of the total 4.5 year study duration. Receives: Drug: Surzetoclax; Drug: Daratumumab; Drug: Dexamethasone |
| Substudy 1: Dose Optimization & Selection ABBV-453 Combination | Experimental | Participants will receive 1 of 2 doses of ABBV-453 in combination with daratumumab + dexamethasone, as part of the total 4.5 year study duration. Receives: Drug: Surzetoclax; Drug: Daratumumab; Drug: Dexamethasone |
| Substudy 1: Dose Optimization & Selection Control | Active comparator | Participants will receive daratumumab, dexamethasone, and pomalidomide, as part of the total 4.5 year study duration. Receives: Drug: Daratumumab; Drug: Dexamethasone; Drug: Pomalidomide |
| Substudy 2: Dose Escalation ABBV-453 Monotherapy | Experimental | Japanese participants will receive various doses of ABBV-453 as a monotherapy, to determine the best dose of ABBV-453, as part of the total 4.5 year study duration. Receives: Drug: Surzetoclax |
| Substudy 3: Dose Escalation Surzetoclax + Etentamig | Experimental | Participants will receive various doses of both surzetoclax and etentamig, to determine the best dose of surzetoclax and etentamig, as part of the total 4.5 year study duration. Receives: Drug: Surzetoclax; Drug: Etentamig |
| Substudy 3: Dose Optimization Etentamig Dose A Combination | Experimental | Participants will receive etentamig dose A in combination with surzetoclax, as part of the total 4.5 year study duration. Receives: Drug: Surzetoclax; Drug: Etentamig |
| Substudy 3: Dose Optimization Etentamig Dose B Combination | Experimental | Participants will receive etentamig dose B in combination with surzetoclax, as part of the total 4.5 year study duration. Receives: Drug: Surzetoclax; Drug: Etentamig |
| Substudy 3: Dose Optimization Etentamig Monotherapy | Experimental | Participants will receive etentamig, as part of the total 4.5 year study duration. Receives: Drug: Surzetoclax; Drug: Etentamig |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-Limiting Toxicities (DLT)s of ABBV-453
DLT events are defined as specific clinically significant adverse events or abnormal laboratory values assessed as events regardless of attribution to ABBV-453, except those clearly and incontrovertibly associated with underlying disease or extraneous causes.
Measured: Up to Approximately 45 Months
Number of Participants with Adverse Events (AE)s
An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Measured: Up to Approximately 4.5 Years
Secondary outcomes (7)
Overall Response Rate (ORR)
ORR is defined as the percentage of participants with a confirmed partial response (PR), very good partial response (VGPR), complete response (CR) or stringent complete response (sCR) per Investigator review according to International Myeloma Working Group (IMWG) 2016 criteria.
Measured: Up to Approximately 4.5 Years
Progression-Free Survival (PFS)
PFS is defined as time from first study treatment to the earliest documented disease progression according to IMWG 2016 criteria, as determined by the investigator, or death due to any cause, whichever occurs earlier.
Measured: Up to Approximately 4.5 Years
Duration of Response (DOR)
DOR is defined as the time from the date of achieving the first confirmed sCR/CR/VGPR/PR to the date of recurrence, disease progression according to IMWG 2016 criteria, as determined by the investigator, or death of any cause, whichever occurs earlier.
Measured: Up to Approximately 4.5 Years
Time-to-Progression (TTP)
TTP will be defined as the number of days from the date of first dose to the date of earliest disease progression.
Measured: Up to Approximately 4.5 Years
Time to Next Treatment
Time to next treatment will be defined as the number of days from the date of first dose to the date of next treatment.
Measured: Up to Approximately 4.5 Years
Minimal Residual Disease (MRD) Negativity
MRD negativity is defined as having less than 1 myeloma cell that may remain in the bone marrow aspirate per 10^5 nucleated cells. Rate of MRD negativity will be determined.
Measured: Up to Approximately 4.5 Years
Overall Survival (OS)
OS is defined as time from first study treatment to death due to any cause.
Measured: Up to Approximately 4.5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start23 Jul 2025
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
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.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 325 participants (estimated)
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
- NCT06953960
- Sponsor's protocol ID
- M25-275
- Other IDs
- 2024-517140-65, 2024-517140-65-00
- Status last verified
- Oct 2026
- First submitted
- 17 Apr 2025
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.