Stem cell transplant or drug combo: which works better for myeloma?
NCT ID NCT01745588
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tested two ways to treat multiple myeloma that has come back or stopped responding to treatment. All 23 participants first received a combination of clarithromycin, pomalidomide, and dexamethasone. Then, half got a stem cell transplant followed by pomalidomide, while the other half continued the drug combo. The goal was to see which approach better controls the disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- pomalidomide, clarithromycin, dexamethasone, and autologous stem cell transplant
- What this could lead to
- If successful, this could help doctors choose the best treatment sequence for relapsed multiple myeloma, potentially improving disease control.
- What could go wrong
- This is a small, early-phase study with only 23 participants, so results may not apply to everyone. Both treatments have side effects, and the disease may still progress.
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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23 people
The number who actually took part.
- Start date
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Dec 2012
- Finished
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Sep 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: * Patients must have histologically or cytologically confirmed relapsed multiple myeloma as defined by the International Myeloma Working Group (IMWG). * Patients must have measurable disease as defined by the International Uniform Response Criteria, defined as any of the following: * serum M-protein of ≥ 500mg/dL * urine M-protein of ≥ 200mg/ 24 hours * involved free light chain ≥ 10mg/dL provided serum free light chain ratio is abnormal * Patients must have had a previous auto-SCT performed as part of a consolidation of an initial remission and had a remission, defined as a partial response or greater that lasted at least 12 months either on or off maintenance therapy without evidence of progression as defined by IMWG criteria. * Patients who are post auto-SCT as primary therapy must have received maintenance therapy with lenalidomide. * Patients must be registered within 6 months of last dose of lenalidomide. * Minimum of 3 months of maintenance therapy prior to disease progression. * Age ≥ 18 years. * Life expectancy of ≥12 weeks. * KPS ≥ 70 or ECOG \< 1 (Appendix IV) * Patients must have adequate organ and marrow function as defined below: * ANC ≥ 750/μL * Platelets≥ 50,000/μL * Total bilirubin ≤ 1.5 mg/dL * AST(SGOT) ≤ 3 X upper limit of normal. * ALT(SGPT) ≤ 3 X upper limit of normal. * Cardiac Ejection Fraction ≥ 40% * Serum Creatinine ≤ 2.0 mg/dL * Patients must have an adequate number of CD34+ stem cells collected to allow for transplantation (defined as ≥ 2x10\^6 CD34+ cells / kg body weight). If not previously collected and stored or if previous collection was inadequate, the patient must be willing to undergo stem cell mobilization and collection as per standard practice. * Patients who participate in this study must be willing and able to tolerate prophylactic anticoagulation either with aspirin, low-molecular weight heparin (LMWH), or warfarin. * Ability to understand and the willingness to sign a written informed consent document. * Patient must be determined fit to undergo auto-SCT procedure by a study physician. * Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the POMALYST REMS™ program. Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10 - 14 days and again within 24 hours prior to prescribing pomalidomide (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking pomalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure. * A female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e.,has had menses at any time in the preceding 24 consecutive months). * All study participants must be registered into the mandatory POMALYST REMS™ program, and be willing and able to comply with the requirements of the POMALYST REMS™ program. * A female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months). Exclusion Criteria: * Patients who have had myeloma therapy within 14 days prior to entering the study or those who have not recovered from adverse events due to agents administered more than 2 weeks earlier. Patients may have received bisphosphonate therapy or radiation therapy as part of routine myeloma care at any time prior to study entry. * Patients may not be receiving any other investigational agents. * Any prior use of thalidomide or pomalidomide. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to lenalidomide (including thalidomide) clarithromycin, or melphalan. * Known prior positivity for active HIV or infectious hepatitis, type B or C. * Uncontrolled illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure , unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Pregnant and lactating women are excluded from the study because the risks to an unborn fetus or potential risks in nursing infants are unknown. * History of thrombosis or thromboembolic event within last 30 days prior to study entry. * Patients with CNS involvement.
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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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Memorial Sloan Kettering Cancer Center
Basking Ridge, New Jersey, United States
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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Memorial Sloan Kettering Cancer Center @ Suffolk
Commack, New York, 11725, United States
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Memorial Sloan Kettering Cancer Center at Mercy Medical Center
Rockville Centre, New York, 11570, United States
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Memorial Sloan Kettering Cancer Center at Phelps Memorial Hospital Center
Sleepy Hollow, New York, 10591, United States
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Memorial Sloan Kettering West Harrison
Harrison, New York, 10604, United States
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North Shore LIJ
New Hyde Park, New York, 11040, United States
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Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
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SUNY Upstate Medical University
Syracuse, New York, United States
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Weill Medical College of Cornell University
New York, New York, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- 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
- Banking blood and bone marrow to decode plasma cell disorders
- Which scan sees hidden myeloma better: PET or MRI?