New drug combo aims to tame myeloma in older patients without harsh chemo
NCT ID NCT04151667
First seen Jun 26, 2026 · Last updated Aug 21, 2026 · Updated 3 times
Summary
This Phase II study tests a treatment plan using daratumumab (Darzalex) and dexamethasone for adults aged 65 and older with newly diagnosed multiple myeloma who cannot handle intensive chemotherapy. The goal is to see how well the combination controls the disease by measuring response rates. Thirty-three participants receive the drugs over several months, with the hope of offering a gentler yet effective option.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Daratumumab (Darzalex) and dexamethasone
- What this could lead to
- If successful, this could offer an effective treatment option for older adults with multiple myeloma who cannot tolerate intensive chemotherapy, potentially controlling the disease for longer.
- What could go wrong
- This is a small Phase II study with only 33 participants, so results may not apply to all patients. The treatment may not work as well as hoped, and side effects like infections or allergic reactions are possible.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
33 people
The number who actually took part.
- Started
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Nov 2019
- Finished
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Mar 2026
- 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
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65 years and older
- Sex
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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: * Understand and voluntarily sign an informed consent form * Age 65 years or older and presence of coexisting conditions which in the opinion of the treating physician are likely to result in the development of unacceptable side effects associated with high-dose chemotherapy with stem-cell transplantation * Able to adhere to the study visit schedule and other protocol requirements. * Diagnosed with multiple myeloma and be considered to have active disease with either elevated Calcium, Renal Failure, Anemia, Bone Lesions (CRAB) criteria (hypercalcemia, renal failure, anemia, or bone lesions) or myeloma defining events (bone marrow ≥ 60% plasma cells, serum free light chain (sFLC) ratio≥ 100 or MRI or Positron Emission Tomography \[PET\] defined lesions). Patients must not have received an active chemotherapy regimen. Patients may have received palliative radiotherapy at least 2 weeks prior to the study start. Dexamethasone up to 160 mg total dose is allowed prior to participation * Measurable myeloma paraprotein levels in serum (≥ 0.5 g/dL), urine (≥ 0.2 g excreted in a 24-hour urine collection sample) or by serum free light chains (involved free light chain greater than 100mg/L) * Eastern Cooperative Group (ECOG) Performance Status of 0 - 2. * Serum bilirubin levels \</=1.5 times the upper limit of the normal range for the laboratory (ULN). * Serum Aspirtate Transaminase (AST) or serum Alanine Aminotransferase (ALT) levels \</=2 x Upper Limit of Normal (ULN) * Must have adequate bone marrow function: a. Absolute neutrophil count \> 1,000 cells/mm3 (1.0 x 109/L). b. Platelets \>/= 75,000 /mm3. * Hemoglobin \> 8 g/dL (transfusions are allowed) * Calculated creatinine clearance \>/=30ml/min by Cockcroft-Gault formula. * Men must agree to use a latex condom during sexual contact with a female of child bearing potential even if they have had a successful vasectomy. See Appendix C: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods. Exclusion Criteria: * Ongoing severe infection requiring intravenous antibiotic treatment. * Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer, or other cancer from which the subject has been disease-free for at least 2 years. * Solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia. * Patients with known Chronic Obstructive Pulmonary Disease (COPD) with a forced expiratory volume in 1 second (FEV1) \<50% of predicted normal and , moderate or severe persistent asthma within the past 2 years or uncontrolled asthma. Patients with a history of COPD will have pulmonary function testing to include FEV1 * Uncontrolled medical problems such as diabetes mellitus, congestive heart failure, coronary artery disease, hypertension, unstable angina, arrhythmias), pulmonary, hepatic and renal diseases unless renal insufficiency is felt to be secondary to multiple myeloma. * Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. * Pregnant or lactating females. * Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study. * Concurrent use of other anti-cancer agents or treatments with the exception for hormonal therapy, which is allowed. * Known allergy or hypersensitivity or intolerance to any of the study drugs, hyaluronidase, monoclonal antibodies (mAbs), human proteins, or their excipients (refer to daratumumab IB), or known sensitivity to mammalian derived products * Seropositive for human immunodeficiency virus (HIV) * Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen \[HBsAg\]). Subjects with resolved infection (ie, subjects who are HBsAg negative but positive for antibodies to hepatitis B core antigen \[anti-HBc\] and/or antibodies to hepatitis B surface antigen \[anti-HBs\]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) DNA levels. Those who are PCR positive will be excluded. EXCEPTION: Subjects with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR. * Seropositive for hepatitis C (except in the setting of a Sustained Virologic Response \[SVR\], defined as aviremia at least 12 weeks after completion of antiviral therapy).
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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
-
H. Lee Moffitt Cancer & Research Institute
Tampa, Florida, 33612, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A prospective, Single-Arm, Single-Center, phase II study evaluating the safety and efficacy of CM336 in combination with daratumumab and lenalidomide in Transplant-Ineligible newly diagnosed multiple myeloma
- Carfilzomib - lenalidmide - dexamethasone (KRd) versus lenalidomi - dexamethasone (Rd) in newly diagnosed myeloma patients not eligible for autologous stem cell transplantation: a randomized phas III trial
- Cheap blood count ratios eyed as window into Myeloma's inflammatory grip
- Can a t-cell engager rescue myeloma that outsmarted CAR-T?
- Can myeloma treatment work without steroids?
- Double-Drug attack on Hard-to-Treat lymphomas