Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01208662 · ClinicalTrials.gov registry record · Phase 3
Randomized Trial of Lenalidomide, Bortezomib, Dexamethasone vs High-Dose Treatment With SCT in MM Patients up to Age 65
A Phase 3 study of Multiple Myeloma, sponsored by Paul Richardson, MD.
- Active
- Registry status
- Phase 3
- Development phase
- 729
- Enrollment target
- 20
- Study locations
NCT01208662: Active Phase 3 study of Multiple Myeloma, sponsored by Paul Richardson, MD.
NCT01208662 is a Phase 3 study of Multiple Myeloma that is active but no longer recruiting, run by Paul Richardson, MD. The registered enrollment target is 729 participants, above the 545-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (34% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01208662, a Phase 3 study of Multiple Myeloma, is active but no longer recruiting, sponsored by Paul Richardson, MD.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 729 participants
- Enrollment target
- 20
- Study locations
Study Summary
In this research study, we are looking to explore the drug combination, lenalidomide, bortezomib and dexamethasone alone or when combined with autologous stem cell transplantation to see what side effects it may have and how well it works for treatment of newly diagnosed multiple myeloma. Specifically, the objective of this trial is to determine if, in the era of novel drugs, high dose therapy (HDT) is still necessary in the initial management of multiple myeloma in younger patients. In this study, HDT as compared to conventional dose treatment would be considered superior if it significantly prolongs progression-free survival by at least 9 months or more, recognizing that particular subgroups may benefit more compared to others.
Primary Outcome
PFS was estimated using the Kaplan-Meier (KM) method and defined as time from randomization to the earlier of disease progression (PD) as determined by central review or death from any cause (events). Patients who started non-protocol therapy (NPT) were censored at the date of NPT initiation if available or date treatment ended if date of NPT was missing. Deaths occurring beyond 1 year from the date last known progression-free are not counted as events and censored at date of last disease evalua
Conditions Studied
Interventions
- DRUG Dexamethasone
- DRUG Lenalidomide
- DRUG Bortezomib
- PROCEDURE Autologous Stem Cell Transplant
Study Locations (20)
Massachusetts
- Massachusetts General Hospital - Boston
- Dana-Farber Cancer Institute - Boston
- Beth Israel Deaconess Medical Center - Boston
- Cape Cod Healthcare - Hyannis
- Newton-Wellesley Hospital - Newton
California
- City of Hope - Duarte
- University of California at San Diego - La Jolla
- University of California, San Francisco - San Francisco
- Stanford University - Stanford
Florida
- University of Florida - Gainesville
- H. Lee Moffitt Cancer Center - Tampa
Alabama
- University of Alabama at Birmingham - Birmingham
Arizona
- Arizona Comprehensive Cancer Center - Tucson
Colorado
- Colorado Blood Cancer Institute - Denver
Georgia
- Emory University - Atlanta
Idaho
- Mountain States Tumor Institute at St. Luke's Regional Medical Center - Boise
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 729 participants |
| Start Date | 2010-09 |
| Est. Completion | 2026-12 |
| Phase | Phase 3 |
What the registry record for NCT01208662 still lists
NCT01208662 is an interventional study that assigns participants to a tested intervention. The registered 729 participants enrollment target is mid-sized for trials with a published cap, above the 545-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (34% higher).
The record links to 1 condition, with Multiple Myeloma appearing as the primary indexed condition, and to 4 interventions - of which Dexamethasone is the first listed.
NCT01208662 names 20 study sites across 12 states, led by Massachusetts, California, Florida.
Frequently Asked Questions
What is clinical trial NCT01208662 about?
NCT01208662 is a clinical study titled "Randomized Trial of Lenalidomide, Bortezomib, Dexamethasone vs High-Dose Treatment With SCT in MM Patients up to Age 65". In this research study, we are looking to explore the drug combination, lenalidomide, bortezomib and dexamethasone alone or when combined with autologous stem cell transplantation to see what side effects it may have and how well it works for treatment of newly diagnosed multiple myeloma. Specifical...
What is the current status of trial NCT01208662?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 729 participants. The study started on 2010-09. Estimated completion is 2026-12.
What conditions does trial NCT01208662 study?
This clinical trial studies the following conditions: Multiple Myeloma.
What interventions are being tested in trial NCT01208662?
The interventions under investigation include: Dexamethasone (DRUG), Lenalidomide (DRUG), Bortezomib (DRUG), Autologous Stem Cell Transplant (PROCEDURE).
Who is sponsoring clinical trial NCT01208662?
This trial is sponsored by Paul Richardson, MD, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01208662 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Multiple 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 NCT01208662's enrollment target sits among peer trials
729 32nd of 438 higher than 407 of 438 other Multiple Myeloma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Multiple 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
-
Olanzapine 2.5 vs 5 mg in Quadruplet Nausea/Vomiting Prophylaxis Before High-Dose Melphalan
RECRUITING · Phase 3
-
A Study to Learn About the Study Medicine Elranatamab Alone and With Daratumumab in People With Multiple Myeloma Who Have Received Other Treatments
RECRUITING · Phase 3
-
A Study to Compare Iberdomide Maintenance Versus Lenalidomide Maintenance Therapy Following Autologous Stem Cell Transplant in Participants With Newly Diagnosed Multiple Myeloma
RECRUITING · Phase 3
-
Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation
RECRUITING · Phase 3
-
Study Assessing Activity of Intravenous (IV) Etentamig Monotherapy Versus Standard Available Therapies in Adult Participants With Relapsed or Refractory Multiple Myeloma
RECRUITING · Phase 3
-
A Study Comparing JNJ-79635322 and an Anti-B-cell Maturation Antigen (BCMA)xCD3 Bispecific Antibody in Participants With Relapsed or Refractory Multiple Myeloma
RECRUITING · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03232918 · 730 participants · Phase 4
Oxytocin and Fetal Heart Rate Changes
- NCT05548283 · 730 participants · Phase 4
Standardizing Treatments for Pulmonary Exacerbations - Aminoglycoside Study
- NCT07312162 · 730 participants
Multilevel Determinants of Socioeconomic Disparities in Geographic Late-Stage Hepatocellular Carcinoma Hotspots
- NCT05065216 · 728 participants · Phase 2
Treatment of Acute Ischemic Stroke (ReMEDy2 Trial)
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia