International Myeloma Foundation’s Black Swan Research Initiative Presents Data and Results of Phase 2 ASCENT Cure Trial at EHA 2026 Congress

Quadruplet Dara-KRd combination demonstrates high rates of response in high-risk smoldering myeloma patients similar to that observed in NDMM; MRD negativity maintained in nearly two-thirds of patients, with median follow up of more than 4 years

STOCKHOLM, June 18, 2026 (GLOBE NEWSWIRE) -- The International Myeloma Foundation (IMF) is proud to announce that an oral presentation was conducted for the Black Swan Research Initiative’s® (BSRI) cure trial, Aggressive Smoldering Curative Approach Evaluating Novel Therapies and Transplant (ASCENT) at the European Hematology Association (EHA) 2026 Congress. The annual global hematology conference took place from June 11-14, 2026, in Stockholm, Sweden.

Abstract EHA-6678 Short S207: AGGRESSIVE SMOLDERING CURATIVE APPROACH EVALUATING NOVEL THERAPIES (ASCENT): A PHASE 2 TRIAL OF INDUCTION, CONSOLIDATION, AND MAINTENANCE IN HIGH-RISK SMOLDERING MULTIPLE MYELOMA was presented on Friday, June 12, by IMF Scientific Advisory Board (SAB) Member Shaji Kumar, MD (Mayo Clinic — Rochester, MN) during the session on Amyloidosis and multiple myeloma precursors.

Launched in 2017, the phase 2 ASCENT trial is one of the cure trials funded by the IMF’s Black Swan Research Initiative® (BSRI). The clinical trial is designed to see if early, aggressive treatment leads to deep response that translates into cure.

The ASCENT Trial (NCT03289299) is “a multi-center phase 2 study of carfilzomib, lenalidomide, daratumumab, and dexamethasone (Dara-KRd) in subjects with high-risk smoldering multiple myeloma (SMM),” as described in ClinicalTrials.gov.

This study evaluated the efficacy and safety of fixed-duration treatment with Dara-KRd in patients with high-risk smoldering multiple myeloma (HR SMM), defined by the IMWG 20/2/20 staging system or an IMWG score ≥9. The primary endpoint was stringent complete response (sCR), with secondary endpoints including measurable residual disease (MRD) negativity and progression-free survival (PFS).

Between May 2018 and December 2021, 87 patients with HR SMM (based on the IMWG 20/2/20 staging system or a total score ≥9 on the IMWG scoring system) were enrolled, with 51% males and a median age of 64. Patients received up to 24 cycles of Dara-KRd therapy across induction, consolidation, and maintenance phases. After a median follow-up of 52.4 months, the overall response rate was 97%, including 43 patients who achieved sCR or complete response (CR), and MRD negativity assessed by Euroflow (10^-5sensitivity) was achieved in 85% of patients at a median of 6.6 months. Ten patients progressed, median PFS was not reached, and the estimated 5-year PFS rate was 82%. Grade 3 or higher hematologic toxicities occurred in 22% of patients, and grade 3 or higher non-hematologic toxicities occurred in 70%; five deaths were reported during follow-up.
The estimated 5-year progression-free survival rate was 82%, while treatment-related toxicities were common, including grade 3 or higher hematologic toxicity in 22% of patients and non-hematologic toxicities in 70% of patients.

According to the oral abstract summary and conclusion, “the quadruplet Dara-KRd combination demonstrates high rates of response similar to that observed in newly diagnosed MM, that seem to be maintained in majority of the patients. Toxicities are in line with that observed in newly diagnosed MM. MRD negativity was maintained in nearly two thirds of the patients with a median follow up of more than 4 years. Future trials should explore such highly effective treatment approaches and the newer immunotherapies in this context.”

“The outcomes of patients with myeloma have steadily improved over time with development of new therapies and we are likely curing an increasing number of patients. Given the long precursor phase preceding active myeloma, we have an opportunity to intervene early and potentially cure or at least prevent the progression to active myeloma. The ASCENT trial was a phase 2 trial designed to explore the feasibility of giving intense myeloma type therapy to patients with high-risk smoldering myeloma, albeit for a limited duration, to examine if we can eradicate the clonal plasma cell population. The results of the trial clearly show that this approach can achieve deep reduction in the myeloma clone, but more follow-up is needed to determine if we are curing anyone,” said IMF SAB Member Dr. Kumar.

“The ASCENT trial represents an important step forward in our effort to determine if we can cure myeloma by early intervention at the high-risk smoldering myeloma stage. The depth and durability of response observed in this study demonstrate what is possible when we combine highly effective therapies with a carefully selected patient population. While longer follow-up is needed to determine the ultimate impact on cure, these findings reinforce the importance of continuing to pursue innovative approaches that may alter the natural history of myeloma before organ damage occurs,” said Dr. S. Vincent Rajkumar, Chair of the International Myeloma Foundation’s Board of Directors and Chairperson of the International Myeloma Working Group.

“The ASCENT trial reflects the bold vision that inspired the IMF’s Black Swan Research Initiative nearly a decade ago — to challenge conventional thinking and pursue the possibility of curing myeloma. These results underscore the value of investing in innovative research, global collaboration, and clinical trials designed to improve outcomes for patients before their disease progresses. We are deeply grateful to the patients, investigators, and research teams whose commitment has made this important milestone possible,” said Heather Cooper Ortner, President and Chief Executive Officer of the International Myeloma Foundation.

The International Myeloma Foundation is truly proud and honored to have had the opportunity to present the positive and promising results of the Black Swan Research Initiative’s phase 2 ASCENT cure trial at the EHA 2026 Congress.

ABOUT MULTIPLE MYELOMA
Multiple myeloma is a cancer of the bone marrow plasma cells — white blood cells that make antibodies. A cancerous or malignant plasma cell is called a myeloma cell. Myeloma is called “multiple” because there are frequently multiple patches or areas in bone where it grows. It often involves damage to bone and kidneys. Multiple myeloma is still incurable, but great progress has been made in terms of survival over the last two decades. The disease is twice as common and is diagnosed at a younger age in African Americans than white Americans. The most common presenting symptoms include fatigue and bone pain.

ABOUT THE INTERNATIONAL MYELOMA FOUNDATION
Founded in 1990, the International Myeloma Foundation (IMF) is the world’s leading organization dedicated to multiple myeloma. The IMF is steadfast in its mission: accelerating the prevention and cure of myeloma and improving the quality of life
for patients and families.

The IMF serves people impacted by myeloma at every stage of the disease by combining world-class research, trusted education, global advocacy, and direct support. A cornerstone of this work is the International Myeloma Working Group® (IMWG)—a network of more than 380 internationally renowned researchers and clinicians who establish the guidelines that shape how myeloma is diagnosed, treated, and managed across the globe.

Through its global network of support groups, educational programs, its 24/7 generative-AI myeloma assistant Myelo®, its InfoLine, and its advocacy for greater healthcare access, the IMF helps people living with myeloma and their care partners navigate diagnosis, treatment, and survivorship. At the same time, the IMF ensures scientific advances translate into better care and outcomes.

Learn more at www.myeloma.org or contact the IMF InfoLine at (800) 452-CURE (2873) (U.S. & Canada), +1 (818) 487-7455 (worldwide), or infoline@myeloma.org.

Follow the IMF on:
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LinkedIn: International Myeloma Foundation
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Jason London
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