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Double-Dose transplant strategy shows promise for myeloma patients

NCT ID NCT01241708

Disease control Sponsor: Hackensack Meridian Health 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tested a two-step (tandem) stem cell transplant in 148 people with multiple myeloma. Patients received high-dose melphalan chemotherapy, followed by a second transplant with melphalan plus bortezomib (Velcade). The goal was to see if this approach could delay cancer progression. The trial is complete, and results help guide future treatment options.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Melphalan and Bortezomib (Velcade)
What this could lead to
If successful, this approach could extend the time patients with multiple myeloma live without their cancer worsening.
What could go wrong
This is a completed phase 3 trial, but results may not apply to all patients. High-dose chemotherapy carries risks like infection and organ damage.

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

148 people

The number who actually took part.

Started

Apr 2010

Finished

Jul 2023

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 75 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.

Changed from: Inclusion Criteria: * Confirmed diagnosis of multiple myeloma with either Durie-Salmon stage I, II, or III or ISS stage I, II or III, less than 12 months since initiation of systemic therapy * ≥8x106 CD34+cells/kg available in cryopreservation in aliquots appropriate for tandem transplants * Age: 18-75 years at time of transplantation * KPS 70-100% * Recovery from complications of prior therapies * Gender: There is no gender restriction Exclusion Criteria: * Diagnosis other than multiple myeloma * Chemotherapy or radiotherapy within 8 days of initiating treatment in this study * Prior autologous or allogeneic transplantation (except as enrolled into this study) * Uncontrolled bacterial, viral, fungal or parasitic infections

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma

As listed by the trial registrant

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

Auto stem cell transplant Multiple myeloma

Contacts and locations

Locations

  • John Theurer Cancer Center @ Hackensack University Medical Center

    Hackensack, New Jersey, 07601, United States

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