Clinical Trials
Accessing Tomorrow's Treatments Today
Medical Disclaimer: The following content is compiled based on the latest authoritative guidelines at home and abroad. It is for reference only for patients and their families and cannot replace the professional medical advice of the attending physician. Please be sure to follow the doctor's advice for the treatment plan.
Core Conclusion
Participating in Phase 1 to 3 clinical trials gives patients cost-free access to cutting-edge immunotherapies including CAR-T and bispecific antibodies, with 100% of investigational drug and testing costs fully covered by study sponsors.
Detailed Points
- (1) Why Participation is Encouraged (Early Access to Novel Therapies): Clinical trials are the engine of medical progress. By participating, you have the unique opportunity to be among the very first to receive the newest, most innovative drugs or drug combinations before they are commercially available on the market. Additionally, you will receive incredibly close monitoring from top myeloma experts. The more patients who enroll, the faster researchers can find answers, which is exactly how the life expectancy for myeloma patients has tripled in recent years.
- (2) How Patient Safety and Ethics are Maintained: Your safety is always the highest priority. Before any new drug is ever given to a human, it must pass rigorous laboratory and animal testing (preclinical studies) to prove it is active and safe. If you decide to join a trial, you will go through a strict "informed consent" process; a research team will explain every detail, risk, and benefit before you sign anything. Furthermore, in myeloma trials, you will never receive "no treatment" or just a sugar pill (placebo) alone. You will always receive either the promising new experimental therapy or the absolute best standard of care currently available. Finally, participation is strictly voluntary—you have the absolute right to leave the trial at any time and return to standard treatments.
- (3) The Difference Between Early-Phase and Late-Phase Trials: Clinical trials are conducted in careful, step-by-step phases to ensure safety:
- Phase 1: These are small studies (usually fewer than 50 patients) focused primarily on finding the safest dosage and monitoring for side effects.
- Phase 2: These moderately sized studies focus on testing how effectively the drug fights your specific type of cancer.
- Phase 3: These are large studies (often involving more than 200 patients) that directly compare the new drug against the current standard of care. If the new treatment proves to be better, the U.S. Food and Drug Administration (FDA) may officially approve it.
- (4) The Importance of Asking Your Doctor at Every Stage: A common misconception is that clinical trials are only a "last resort" when all other treatments have failed. In reality, guidelines strongly recommend that clinical trials be considered at every stage of the disease—from asymptomatic smoldering myeloma, to your very first frontline treatment, to late-stage relapsed disease. You should feel empowered to ask your doctor, "Is there a clinical trial that might fit my situation?" every time a new treatment decision needs to be made.
The above content is sourced from the following references
- Patient Handbook
- MULTIPLE MYELOMA TREATMENT OVERVIEW
- MULTIPLE MYELOMA NEWLY DIAGNOSED
- NCCN Guidelines for Patients® Multiple Myeloma
- Management of relapsed multiple myeloma: A British Society of Haematology and UK Myeloma Society guideline
Looking for a clinical trial that fits your needs?
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FAQs
- Why should I consider a myeloma clinical trial?
- Trials are a standard part of excellent myeloma care, not an experiment on a guinea pig. They can give you early access to new drugs or combinations before those treatments are widely available, plus close monitoring by specialists. Broader enrollment is also how life expectancy for myeloma has tripled in recent years.
- Will I receive a placebo?
- In myeloma trials you will never receive no treatment or a sugar pill alone. You always receive either the new experimental therapy or the current best standard of care. Before you join, a research team explains every detail, risk, and benefit through informed consent.
- What is the difference between trial phases?
- Phase 1 studies are small, usually fewer than 50 patients, and focus on the safest dose and side effects. Phase 2 studies test how well the drug fights your type of cancer. Phase 3 studies are large, often more than 200 patients, and compare the new treatment with standard care; if it is better, the FDA may approve it.
- Are clinical trials only a last resort?
- No. Guidelines recommend considering a trial at every stage, from smoldering myeloma to first treatment to late relapse. Ask your doctor whether a study fits your situation whenever a new treatment decision is being made.
- Can I leave a trial if I change my mind?
- Yes. Participation is strictly voluntary. You have the right to leave at any time and return to standard treatments.
Related reading
References used for this guide
Featured Nationwide Phase 3 Confirmatory Registration Trials
Large-scale multi-center Phase 3 trials recruiting at major tertiary medical centers nationwide:
A Randomized, Controlled, Double-Blind, Multicenter Phase III Clinical Trial Evaluating the Efficacy and Safety of SG301 Injection Combined with Pomalidomide and Dexamethasone Versus Placebo Combined with Pomalidomide and Dexamethasone in the Treatment of Relapsed/Refractory Multiple Myeloma (RRMM)
This project is a Phase III clinical trial sponsored by Hangzhou SJ Biosciences Co., Ltd. (Hangzhou Shangjian Biotechnology Co., Ltd.), primarily targeting participants with relapsed/refractory multiple myeloma (RRMM) who have received at least 1 prior line of therapy, have not previously received pomalidomide, and whose prior anti-CD38 antibody therapy was not determined to be refractory/ineffective. The treatment regimen utilizes an anti-CD38 monoclonal antibody (SG301 injection) combined with an immunomodulator (pomalidomide) and a glucocorticoid (dexamethasone), administered in 4-week (28-day) cycles until disease progression or intolerable toxicity. The trial is being conducted across a total of 78 top domestic hospitals in China, including the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences; The First Affiliated Hospital of Soochow University; Beijing Chaoyang Hospital, Capital Medical University; The Second Affiliated Hospital, Zhejiang University School of Medicine; and Sun Yat-sen University Cancer Center, among others.
A Phase III, Randomized Study Comparing JNJ-79635322 and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma Who Have Received 1 to 3 Prior Lines of Therapy (Including an Anti-CD38 Antibody and Lenalidomide)
This study aims to evaluate the efficacy and safety of JNJ-79635322 versus teclistamab in the treatment of multiple myeloma. The trial mainly enrolls adult participants with relapsed or refractory disease who have received 1 to 3 prior lines of anti-myeloma therapy (including an anti-CD38 antibody and lenalidomide). Eligible participants will be randomized to receive subcutaneous injections of JNJ-79635322 or teclistamab. This is an international multicenter study conducted simultaneously in multiple hospitals, including the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences.
A Multicenter, Randomized, Controlled, Open-Label, Phase III Clinical Study of IBI3003 Versus Investigator's Choice of Regimen (DPd or PVd) on the Efficacy and Safety in Participants with Relapsed or Refractory Multiple Myeloma
This study is a multicenter, randomized, controlled, open-label Phase III clinical study in patients with relapsed or refractory multiple myeloma. The study aims to evaluate the efficacy and safety of IBI3003 compared with investigator's choice of regimen (DPd or PVd). The trial is open to participants aged 18 and older who meet the eligibility criteria, and is conducted across multiple hospitals including Zhongshan Hospital, Fudan University.
A Two-Stage, Randomized, Multicenter, Controlled, Open-Label, Phase III Study Comparing Iberdomide Maintenance Therapy with Lenalidomide Maintenance Therapy Following Autologous Stem Cell Transplantation (ASCT) in Participants with Newly Diagnosed Multiple Myeloma (NDMM)
This project is a Phase III clinical trial sponsored by Celgene (Bristol Myers Squibb/BMS), primarily targeting patients with newly diagnosed multiple myeloma (NDMM). Eligible patients must have received 3 to 6 cycles of prior induction therapy (including a proteasome inhibitor and an immunomodulatory drug), subsequently completed autologous stem cell transplantation (ASCT), and achieved at least a partial response (PR). Patients are randomized to receive maintenance therapy with either the investigational drug Iberdomide (a novel immunomodulatory agent administered for 21 days of each 28-day cycle) or the control drug lenalidomide (a conventional immunomodulatory agent administered continuously in 28-day cycles) until disease progression or unacceptable toxicity. The trial is conducted concurrently across 38 premier centers in China (including Hong Kong and Taiwan)—such as Peking University People's Hospital, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, The First Affiliated Hospital of Zhejiang University School of Medicine, Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology, and Qilu Hospital of Shandong University—as well as leading international medical centers across 32 countries, including the United States, the United Kingdom, France, Japan, and Australia.
for their academic support:
for myeloma patients globally