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NCT02960555 · ClinicalTrials.gov registry record · Phase 2
Isatuximab With or Without Lenalidomide in Patients With High Risk Smoldering Multiple Myeloma (ISAMAR)
A Phase 2 study of Smoldering Plasma Cell Myeloma, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 61
- Enrollment target
- 3
- Study locations
NCT02960555: Active Phase 2 study of Smoldering Plasma Cell Myeloma, sponsored by M.D. Anderson Cancer Center.
NCT02960555 is a Phase 2 study of Smoldering Plasma Cell Myeloma that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 61 participants, below the 133-participant average among 9 other Smoldering Plasma Cell Myeloma trials with a reported enrollment target (54% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02960555, a Phase 2 study of Smoldering Plasma Cell Myeloma, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 61 participants
- Enrollment target
- 3
- Study locations
Study Summary
This is a multi-center, open label, phase II study designed to evaluate the efficacy of isatuximab with or without lenalidomide when given to patients with high risk smoldering multiple myeloma.
Primary Outcome
The trial will be conducted by the Simon's optimal two-stage design and the response rate will be estimated accordingly. Summary statistics will be provided for continuous variables. Frequency tables will be used to summarize categorical variables. Logistic regression will be utilized to assess the effect of patient prognostic factors on the response rate and the adverse event rate.
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- BIOLOGICAL Isatuximab
Study Locations (3)
New York
- Mount Sinai Hospital - New York
- Memorial Sloan Kettering Cancer Center - New York
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2017-02-08 |
| Est. Completion | 2030-04-30 |
| Phase | Phase 2 |
What the registry record for NCT02960555 still lists
NCT02960555 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 133-participant average among 9 other Smoldering Plasma Cell Myeloma trials with a reported enrollment target (54% lower).
The record links to 1 condition, with Smoldering Plasma Cell Myeloma appearing as the primary indexed condition, and to 2 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT02960555 reports a single indexed study location in New York, Texas.
Frequently Asked Questions
What is clinical trial NCT02960555 about?
NCT02960555 is a clinical study titled "Isatuximab With or Without Lenalidomide in Patients With High Risk Smoldering Multiple Myeloma (ISAMAR)". This is a multi-center, open label, phase II study designed to evaluate the efficacy of isatuximab with or without lenalidomide when given to patients with high risk smoldering multiple myeloma.
What is the current status of trial NCT02960555?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 61 participants. The study started on 2017-02-08. Estimated completion is 2030-04-30.
What conditions does trial NCT02960555 study?
This clinical trial studies the following conditions: Smoldering Plasma Cell Myeloma.
What interventions are being tested in trial NCT02960555?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Isatuximab (BIOLOGICAL).
Who is sponsoring clinical trial NCT02960555?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02960555 being conducted?
This trial has 3 study locations across New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Smoldering Plasma Cell Myeloma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02960555's enrollment target sits among peer trials
61 6th of 9 higher than 4 of 9 other Smoldering Plasma Cell Myeloma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Smoldering Plasma Cell Myeloma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
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-
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-
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-
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