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Major trial tests if newer drugs can replace stem cell transplants for myeloma

NCT ID NCT01208662

Disease control Sponsor: Paul Richardson, MD Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at 729 people with newly diagnosed multiple myeloma, aged up to 65. It compared a standard drug combination (lenalidomide, bortezomib, and dexamethasone) to the same drugs plus a stem cell transplant using the patient's own cells. The goal was to see if the transplant helped people live longer without the cancer getting worse. The results help doctors decide the best first treatment for younger myeloma patients.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

729 people

The number who actually took part.

Start date

Sep 2010

Expected to finish

Dec 2026

An estimate. End dates often move.

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

18 to 65 years

Sex

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

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 Multiple Myeloma, according to the International Myeloma Foundation 2003 Diagnostic Criteria * Documented symptomatic myeloma, with organ damage related to myeloma with laboratory assessments performed within 21 days of registration * Myeloma that is measurable by either serum or urine evaluation of the monoclonal component or by assay of serum free light chains. * ECOG performance status \</= 2 * Negative HIV blood test * Voluntary written informed consent Exclusion Criteria: * Pregnant or lactating female * Prior systemic therapy for MM (localized radiotherapy allowed if at least 7 days before study entry, corticosteroids allowed if dose \</= equivalent of 160 mg dexamethasone over 2 weeks) * Primary amyloidosis (AL) or myeloma complicated by amylosis * Receiving any other investigational agents * Known brain metastases * Poor tolerability or allergy to any of the study drugs or compounds of similar composition * Platelet count \<50,000/mm3, within 21 days of registration * ANC \<1,000 cells/mm3, within 21 days of registration * Hemoglobin \<8 g/dL, within 21 days of registration * Hepatic impairment (\>/= 1.5 x institutional ULN or AST (SGOT), ALT (SGPT), or alkaline phosphatase \>2 x ULN). Patients with benign hyperbilirubinemia are eligible. * Renal insufficiency (serum creatinine \>2.0 mg/dl or creatinine clearance \<50 ml/min, within 21 days of registration) * Respiratory compromise (DLCO \< 50%) * Clinical signs of heart or coronary failure or LVEF \< 40%. Myocardial infarction within 6 months prior to enrollment, NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conductive system abnormalities * Intercurrent illness including, but not limited to ongoing or active severe infection, known infection with hepatitis B or C virus, poorly controlled diabetes, severe uncontrolled psychiatric disorder or psychiatric illness/social situations that would limit compliance with study requirements * Previous history of another malignant condition except for basal cell carcinoma and stage I cervical cancer. If malignancy was experienced more than 2 years ago and confirmed as cured, these participants may be considered for the study on case by case basis with PI discussion. * Inability to comply with an anti-thrombotic treatment regimen * Peripheral neuropathy \>/= Grade 2

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma plasma cell neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Multiple myeloma

Contacts and locations

Locations

  • Arizona Comprehensive Cancer Center

    Tucson, Arizona, 85724, United States

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201, United States

  • Baylor College of Medicine

    Houston, Texas, 77030, United States

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Cape Cod Healthcare

    Hyannis, Massachusetts, 02601, United States

  • City of Hope

    Duarte, California, 91010, United States

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218, United States

  • Columbia University

    New York, New York, 10032, United States

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115, United States

  • Duke University

    Durham, North Carolina, 27710, United States

  • Eastern Maine Medical Center

    Brewer, Maine, 04412, United States

  • Emory University

    Atlanta, Georgia, 30322, United States

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111, United States

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109, United States

  • H. Lee Moffitt Cancer Center

    Tampa, Florida, 33612, United States

  • Huntsman Cancer Institute

    Salt Lake City, Utah, United States

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10021, United States

  • Mount Sinai Medical Center

    New York, New York, 10029, United States

  • Mountain States Tumor Institute at St. Luke's Regional Medical Center

    Boise, Idaho, 83712, United States

  • New Hampshire Oncology and Hematology

    Concord, New Hampshire, United States

  • New Hampshire Oncology and Hematology

    Hooksett, New Hampshire, United States

  • New Hampshire Oncology and Hematology

    Laconia, New Hampshire, United States

  • Newton-Wellesley Hospital

    Newton, Massachusetts, United States

  • North Shore Long Island Jewish Health System

    Lake Success, New York, 11042, United States

  • Ochsner Foundation Clinic

    New Orleans, Louisiana, 70121, United States

  • Ohio State University Medical Center

    Columbus, Ohio, 43210, United States

  • Oregon Health and Sciences

    Portland, Oregon, United States

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263, United States

  • Stanford University

    Stanford, California, 94305, United States

  • State University of New York Downstate Medical Center

    Brooklyn, New York, United States

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294, United States

  • University of California at San Diego

    La Jolla, California, United States

  • University of California, San Francisco

    San Francisco, California, 94143, United States

  • University of Chicago

    Chicago, Illinois, 60637, United States

  • University of Florida

    Gainesville, Florida, 32608, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216, United States

  • University of Pennsylvania Medical Center

    Philadelphia, Pennsylvania, 19104, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15232, United States

  • University of Rochester Medical Center

    Rochester, New York, 14642, United States

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • Vanderbilt University

    Nashville, Tennessee, 37203, United States

  • Wake Forest University

    Winston-Salem, North Carolina, 27157, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.