Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial (NCT02316106) involved 123 people with a condition called smouldering multiple myeloma — a form of the disease that has not yet caused symptoms. Participants were divided equally into three groups of 41, each receiving a different treatment schedule using the drug daratumumab: a long intensive schedule (Arm A), an intermediate schedule (Arm B), and a short intensive schedule (Arm C). The trial was measuring things like how many people achieved a complete response (meaning no detectable signs of the disease in blood, urine, or bone marrow), how quickly the disease progressed or people died, and how long people went before needing their next treatment. The reported data shows that for the primary measure of complete response, 4.9% of people in Arm A, 12.2% in Arm B, and 0% in Arm C reached that level. For the rate of disease getting worse or death (measured as events per year of follow-up), the figures were very similar across all three groups: 0.096 for Arm A, 0.102 for Arm B, and 0.109 for Arm C. For the broader measure of any meaningful response to treatment (partial response or better), the reported figures were 56.1% in Arm A, 56.1% in Arm B, and 37.5% in Arm C. The reported data shows that the estimated time before the disease progressed (known as progression-free survival) was around 81 months for Arm A, 84 months for Arm B, and 81 months for Arm C. For time until participants needed their next treatment, a specific number was only reported for Arm C (76.3 months); figures for Arms A and B were not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 39652826) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 2 Myeloma Trial, Completed
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You have been diagnosed with smoldering multiple myeloma (a early, inactive form of blood cancer) for less than 5 years.
- Your smoldering multiple myeloma has been confirmed as intermediate or high risk, and you are generally able to carry out normal daily activities with little or no limitation (confirm with trial site for exact fitness level required).
Who may not be able to join:
- Your multiple myeloma has become active and already requires treatment.
- You have a condition called primary AL amyloidosis, which is a disease where abnormal proteins build up in organs.
- You have previously had, or are currently receiving, any approved or experimental treatment for smoldering or active multiple myeloma, including a specific type of therapy targeting a protein called CD-38 (such as daratumumab).
- You have been taking steroid medicines (such as prednisone) at a dose higher than 10mg per day, unless it is a stable dose for a non-cancer condition (confirm with trial site).
- You are taking bone-strengthening medicines (such as bisphosphonates or denosumab), unless the dose is stable and they are being used for a non-cancer condition (confirm with trial site).
- You have taken part in another experimental drug study or used an experimental medical device within the 4 weeks before the trial starts.
- You have had another type of cancer within the last 3 years, with some exceptions such as certain treated and no longer active skin cancers, early-stage cervical cancer, or early-stage breast cancer (confirm with trial site for the full list of exceptions).
- You have a lung condition called chronic obstructive pulmonary disease (COPD), or you have had moderate to severe persistent asthma in the past 2 years.
- You have another ongoing medical or mental health condition that could interfere with the trial or that the trial doctors believe could put you at risk by taking part (confirm with trial site).
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
4 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Percentage of Participants Who Achieved a Complete Response (CR) by International Myeloma Working Group (IMWG) Criteria; Progressive Disease or Death Rate
Can't join this trial?
Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.