Triple-Drug attack shows promise against multiple myeloma
NCT ID NCT02441686
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This completed Phase 2 study tested a combination of three drugs—lenalidomide, bortezomib, and dexamethasone (RVD)—in 46 people newly diagnosed with multiple myeloma. The goal was to see how well the drugs worked before a stem cell transplant. The study measured response rates and side effects like nerve damage.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- lenalidomide, bortezomib, and dexamethasone (RVD combination)
- What this could lead to
- If successful, this combination could become a standard initial treatment for newly diagnosed multiple myeloma, improving response rates before stem cell transplant.
- What could go wrong
- This is a small Phase 2 trial with only 46 participants, so results may not apply to all patients. Side effects like nerve damage 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
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46 people
The number who actually took part.
- Started
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Dec 2015
- Finished
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Oct 2025
- Lead sponsor
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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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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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: * Diagnosis of symptomatic MM, according to International Myeloma Foundation 2003 Diagnostic Criteria: * Clonal plasma cells \>10% on bone marrow biopsy * A monoclonal protein (paraprotein) in either serum or urine(except in cases of non-secretory myeloma)\* * Myeloma-related organ dysfunction (1 or more) of the following (evidence of end-organ damage felt related to the plasma cell disorder related organ or tissue impairment (ROTI), commonly referred to by the acronym "CRAB"): * Serum Ca ≥ 10.5 mg/dL or * Renal insufficiency attributable to myeloma. Serum creatinine \> 2mg/dL * Anemia: Normochromic, normocytic with a hemoglobin value \> 2g/dL below the lower limit of normal or a hemoglobin \<10 g/dL * Bone lesions (lytic lesions, severe osteopenia or pathologic fractures) or osteoporosis. \*If no monoclonal protein is detected (non-secretory disease), then \>/= 30% monoclonal bone marrow plasma cells and/or a biopsy-proven plasmacytoma required. * Has received no prior treatment with any systemic therapy for the treatment of multiple myeloma * Prior treatment of hypercalcemia or spinal cord compression with corticosteroids does not disqualify the patient (the dose should not exceed the equivalent of 160 mg of dexamethasone in a 2 week period). * Bisphosphonates are permitted. * Local radiation as long as two weeks have lapsed since last date of radiotherapy, which is recommended to be a limited field. * Age ≥18 years at the time of signing Informed Consent * ECOG performance status ≤ 2 (Karnofsky ≥ 50%) * Voluntary written informed consent * Subject must be able to adhere to the study visit schedule and other protocol requirements. * Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS® program. Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 µL/mL 10 to14 days prior to therapy and repeated again within 24 hours prior to prescribing lenalidomide for Cycle 1 and must either commit to complete abstinence from heterosexual contact or begin TWO acceptable methods of birth control, one highly effective method and one additional effective (barrier) method, AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must practice complete abstinence or agree to use a condom during sexual contact with a FCBP even if they have had a successful vasectomy. All study participants must be registered into the mandatory Revlimid REMS® program, and be willing and able to comply with the requirements of the REMS® program- Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study. * Renal insufficiency (serum creatinine levels \> 2.5 mg/dL, calculated Crcl with Cockcroft-Gault formula, see Appendix B, \< 45 ml/min) * Subjects with evidence of mucosal or internal bleeding and/or platelet refractory (i.e., unable to maintain a platelet count ≥ 50,000 cells/mm3) * Subjects with an absolute neutrophil count (ANC) \< 1000 cells/mm3. Growth factors may not be used to meet ANC eligibility criteria * Subjects with a hemoglobin \< 8.0 g/dL * AST (SGOT) and ALT (SGPT) \> 2 x institutional ULN, bilirubin levels ≥1.5 institutional ULN * Concomitant therapy medications that include corticosteroids (except as indicated in inclusion criteria). * Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure (Appendix C), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. * Clinically relevant active infection requiring treatment (antibiotics, antivirals, antifungals). * Any serious co-morbid condition, including laboratory abnormalities, that in the opinion of the Investigator places the subject at unacceptable risk if he/she were to participate in the study. * Female subject is pregnant or breast-feeding. * Serious psychiatric illness or addiction likely to interfere with participation in this clinical study. * Uncontrolled diabetes mellitus. * Contraindication to any required concomitant drugs or supportive therapies including hypersensitivity to all anticoagulation and antiplatelet options or hypersensitivity to acyclovir or similar anti-viral drug. * History of allergic reaction/hypersensitivity attributed to compounds containing boron, mannitol, polysorbate 80 or sodium citrate dehydrate. * POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein (M-protein) and skin changes). * Known seropositive for or active HIV infection or hepatitis B or C viral infection. * Patients who are seropositive because of hepatitis B virus vaccine are eligible. * Known intolerance to steroid therapy. * Patient has hypersensitivity to bortezomib, boron, or mannitol. * Diagnosed or treated for another malignancy within 2 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy. * Participation in clinical trials with other investigational agents not included in this trial, within 14 days of the start of this trial and throughout the duration of this trial. * Radiation therapy within 2 weeks of enrollment. Enrollment of subjects who require concurrent radiotherapy (which must be localized in its field size) should be deferred until the radiotherapy is completed and 2 weeks have elapsed since the last date of therapy. * Participant must be able to swallow pills.
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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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Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
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Colorado Blood Cancer Institute
Denver, Colorado, 80218, United States
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Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
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Eastern Maine Medical Center
Brewer, Maine, 04412, United States
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Hematology Oncology of Northern New Jersey
Morristown, New Jersey, 07962, United States
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Massachusetts General Hosptial
Boston, Massachusetts, 02114, United States
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Virgina Piper Cancer Institute
Minneapolis, Minnesota, 55407, United States
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Virginia Piper Cancer Institute
Coon Rapids, Minnesota, 55433, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Bispecific antibody combo aims to deepen myeloma responses
- Can a stronger drug cocktail give older myeloma patients a better start?
- 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