Evidence map›Paper›PMID 39236068›Full record

SynthesisThe oncologist2025

Evaluating early intervention in smoldering myeloma clinical trials: a systematic review.

Apoorva Kakkilaya, Aaron Trando, Edward R Scheffer Cliff, Hira Mian, Samer Al Hadidi, Muhammad Aziz, Aaron M Goodman, Ah-Reum Jeong, Wade L Smith, Amar H Kelkar and 5 more

Abstract readSystematic Review
In one paragraph

Synthesis in The oncologist, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Review
  4. Review
  5. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors.

Apoorva KakkilayaJohn Sealy School of Medicine, University of Texas Medical Branch, Galveston, TX, United States.
Aaron TrandoSchool of Medicine, University of California San Diego, La Jolla, CA, United States.
Edward R Scheffer CliffProgram on Regulation, Therapeutics and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, United States.ORCID 0000-0001-5977-907X
Hira MianDivision of Hematology, McMaster University, Hamilton, Canada.
Samer Al HadidiMyeloma Center, Winthrop P. Rockefeller Cancer Institute, University of Arkansas for Medical Sciences, Little Rock, AR, United States.ORCID 0000-0003-4297-8042
Muhammad AzizDivision of Gastroenterology and Hepatology, University of Toledo, Toledo, OH, United States.
Aaron M GoodmanDivision of Blood and Marrow Transplantation, University of California San Diego, La Jolla, CA, United States.
Ah-Reum JeongDivision of Blood and Marrow Transplantation, University of California San Diego, La Jolla, CA, United States.
Wade L SmithMulford Health Science Library, University of Toledo, Toledo, OH, United States.
Amar H KelkarDepartment of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, United States.
David A Russler-GermainDivision of Oncology, Washington University School of Medicine, St. Louis, MO, United States.
Nikita MehraDepartment of Medical Oncology, Cancer Institute (WIA), Chennai, India.
Rajshekhar ChakrabortyHerbert Irving Comprehensive Cancer Center, Columbia University Irving Medical Center, New York, NY, United States.ORCID 0000-0001-7336-3003
Morie A GertzDivision of Hematology, Mayo Clinic, Rochester, MN, United States.
Ghulam Rehman MohyuddinDivision of Hematology, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, United States.ORCID 0000-0001-6464-783X

Funding

Project 4: Targeting Resistance to T-Cell Directed Therapy in Multiple MyelomaP50CA186781 · NCI · MAYO CLINIC ARIZONA · PI Peter Leif Bergsagel · 2015 to 2026
$25.5M
Washington University Paul Calabresi K12 Career Development Award for Clinical OncologyK12CA167540 · NCI · WASHINGTON UNIVERSITY · PI John F. Dipersio, Ramaswamy Govindan · 2012 to 2026
$11.7M
NCI NIH HHS K12 CA167540NCI NIH HHS P50 CA186781
6 · The paper itself

Abstract

backgroundSmoldering multiple myeloma (SMM), an asymptomatic precursor of multiple myeloma (MM), carries a variable risk of progression to MM. There is little consensus on the efficacy or optimal timing of treatment in SMM. We systematically reviewed the landscape of all clinical trials in SMM. We compared the efficacy of treatment regimens studied in SMM to results from these regimens when used in newly diagnosed multiple myeloma (NDMM), to determine whether the data suggest deeper responses in SMM versus NDMM.

methodsAll prospective interventional clinical trials for SMM, including published studies, meeting abstracts, and unpublished trials listed on ClinicalTrials.gov up to April 1, 2023, were identified. Trial-related variables were captured, including treatment strategy and efficacy results. Relevant clinical endpoints were defined as overall survival (OS) and quality of life.

resultsAmong 45 SMM trials identified, 38 (84.4%) assessed active myeloma drugs, while 7 (15.6%) studied bone-modifying agents alone. Of 18 randomized trials in SMM, only one (5.6%) had a primary endpoint of OS; the most common primary endpoint was progression-free survival (n = 7, 38.9%). Among 32 SMM trials with available results, 9 (28.1%) met their prespecified primary endpoint, of which 5 were single-arm studies. Six treatment regimens were tested in both SMM and NDMM; 5 regimens yielded a lower rate of very good partial response rate or better (≥VGPR) in SMM compared to the corresponding NDMM trial (32% vs 63%, 43% vs 53%, 40% vs 63%, 86% vs 89%, 92% vs 95%, and 94% vs 87%, respectively).

conclusionIn this systematic review of all prospective interventional clinical trials in SMM, we found significant variability in trial design, including randomization status, primary endpoints, and types of intervention used. Despite the statistical limitations, comparison of treatment regimens revealed no compelling evidence that the treatment is more effective when introduced early in SMM compared to NDMM.

Indexed as

Multiple MyelomaSmoldering Multiple MyelomaClinical Trials as TopicHumanslenalidomidemyelomaprecursor conditionpublication biassmoldering myelomasystematic review

Identifiers

PMID39236068
PMCPMC11883161

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.