New drug combo aims to keep myeloma in check after transplant
NCT ID NCT02420860
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase II trial tests whether adding elotuzumab to standard lenalidomide maintenance therapy can prevent multiple myeloma from returning after an autologous stem cell transplant. About 113 newly diagnosed patients who had a transplant will receive the combination. The goal is to see if the two drugs together extend the time before the cancer progresses.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- elotuzumab and lenalidomide
- What this could lead to
- If it works, this combination could help keep multiple myeloma from coming back after a stem cell transplant, extending the time patients stay in remission.
- What could go wrong
- This is a mid-stage trial with 113 participants, so results are not yet conclusive. Adding elotuzumab may increase side effects without guaranteeing better outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
113 people
The number who actually took part.
- Started
-
Apr 2015
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients must have undergone autologous stem cell transplantation, within 18 months of initiation of induction therapy for newly diagnosed myeloma * Time to initiation of maintenance therapy: patients may start maintenance therapy as early as 60 days post-transplant and up to 210 days post-transplant; as long as they meet the following criteria: * Platelet count \>= 100,000/mm\^3 * Neutrophil count \>= 1000/mm\^3 (no growth factors within 5 days) * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 3 x ULN * Creatinine \< 2.5 mg/dl * Recovered (i.e., =\< grade 1 toxicity) from the reversible effects of autologous stem cell transplant * Patients whose primary therapy was changed due to suboptimal response or toxicity will be eligible, however no more than 2 regimens will be allowed prior to ASCT * Patients must have an Eastern Cooperative Oncology Group (ECOG) status of 0 to 2 * Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care * Female patients who: are postmenopausal for at least 24 months before the screening visit, OR; are surgically sterile, OR; if they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, 28 days prior to starting study drug, during study treatment and for 28 days after the last dose of study treatment, OR agree to completely abstain from heterosexual intercourse; male patients, even if surgically sterilized (i.e., status post vasectomy), who: agree to practice effective barrier contraception during the entire study treatment period and through 28 days after the last dose of study treatment, OR; agree to completely abstain from heterosexual intercourse Exclusion Criteria: * Major surgery within 14 days before the first dose of study drug * Radiotherapy within 14 days before enrollment * Known active central nervous system involvement * Inability to swallow oral medication, inability or unwillingness to comply with the drug administration requirements, or gastrointestinal (GI) procedure that could interfere with the oral absorption or tolerance of treatment * Female subject is pregnant or lactating * Known active hepatitis B virus hepatitis, or known active hepatitis C virus * Infection requiring systemic IV antibiotic therapy within 7 days before cycle 1 day 1 of therapy * Known allergy to any of the study medications, their analogues, or excipients in the various formulations * Failure to have fully recovered (i.e., =\< grade 1 toxicity) from the effects of prior chemotherapy regardless of the interval since last treatment * Co-morbid systemic illnesses or other severe concurrent disease that, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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M D Anderson Cancer Center
Houston, Texas, 77030, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a cancer drug's real-world performance match clinical trial results?
- Can a maintenance drug keep myeloma at bay?
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- Could a tiny dose of radiation ease myeloma bone pain?
- Could a common allergy pill ease bone pain in myeloma treatment?