Completed

Stem Cell Transplantation in Individuals With Multiple Myeloma (BMT CTN 0102)

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What is being tested

One Autologous Transplant

+ Non-Myeloablative Allogeneic Transplant
+ Second Autologous Transplant
Procedure
Drug
Behavioral
Who is being recruted

Multiple Myeloma

Until 70 Years
+24 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: December 2003

See protocol details

Summary

Principal SponsorNational Heart, Lung, and Blood Institute (NHLBI)
Last updated: November 1, 2021
Sourced from a government-validated database.Claim as a partner
Study start date: December 1, 2003Actual date on which the first participant was enrolled.

The study is designed as a Phase III, multi-center trial of tandem autologous transplants versus the strategy of autologous followed by Human Leukocyte Antigen (HLA)-matched sibling non-myeloablative allogeneic transplant. Study subjects will be biologically assigned to the appropriate arm depending on the availability of an HLA-matched sibling. There is a nested randomized phase III trial of observation versus maintenance therapy following the second autologous transplant for patients on the tandem autologous transplant arm. Multiple myeloma (MM), characterized by malignant plasma cell proliferation, bone destruction, and immunodeficiency, is a disease with a median age at diagnosis of approximately 65 years. It is responsible for about 1 percent of all cancer-related deaths in Western Countries. Conventional treatments with chemotherapy and radiation therapy are non-curative but improve quality of life and duration of survival. Attempts to cure myeloma through high-dose therapy followed by autografting or allografting have largely failed due to a combination of relapsed disease or transplant related mortality (TRM). High-dose therapy with autologous transplantation is safe and has low TRM (less than 5%), but is associated with a continuing and nearly universal risk of disease progression and relapse. Even so, autologous transplantation is superior to continued conventional chemotherapy. Recent data indicate that tandem autologous transplants are superior to a single procedure. Even with this approach, patients remain at risk of relapse and additional approaches are needed. DESIGN NARRATIVE: The overall study design is that of biologic assignment, based on the availability of an HLA-matched sibling, to one of two treatment strategies for MM patients. Patients without an HLA-matched sibling will undergo tandem autologous transplants. Patients with an HLA-matched sibling will undergo an autologous transplant followed by a non-myeloablative allogeneic transplant. In addition, the tandem autologous transplant recipients will be randomized to either observation or one year of maintenance therapy to begin following the second autologous transplant. The large number of MM patients without an HLA-matched sibling enables us to evaluate the role of maintenance therapy following tandem autologous transplants.

Official TitleA Trial of Tandem Autologous Stem Cell Transplants +/- Post Second Autologous Transplant Maintenance Therapy vs Single Autologous Stem Cell Transplant Followed by Matched Sibling Non-myeloablative Allogeneic Stem Cell Transplant for Patients With Multiple Myeloma (BMT CTN #0102) 
Principal SponsorNational Heart, Lung, and Blood Institute (NHLBI)
Last updated: November 1, 2021
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
710 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants receive different treatments one after the other, switching from one to another during the study. This helps researchers understand how individuals respond to multiple treatments.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Until 70 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Multiple Myeloma
Criteria
11 inclusion criteria required to participate
Meeting the Durie and Salmon criteria for initial diagnosis of MM
Stage II or III MM at diagnosis or anytime thereafter
Symptomatic MM requiring treatment at diagnosis or anytime thereafter
Received at least three cycles of initial systemic therapy and are within 2-10 months of initiation of the initial therapy (this time frame excludes the time for mobilization therapy)

Show More Criteria

13 exclusion criteria prevent from participating
Never advanced beyond Stage I MM since diagnosis
Non-secretory MM (absence of a monoclonal protein \[M protein\] in serum as measured by electrophoresis and immunofixation and the absence of Bence Jones protein in the urine defined by use of conventional electrophoresis and immunofixation techniques)
Plasma cell leukemia
Karnofsky performance score less than 70%, unless approved by the Medical Monitor or one of the Protocol Chairs

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
3 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Active Comparator
One autologous transplant along with a second autologous transplant will be preformed followed by one year of Dexamethasone and Thalidomide maintenance therapy.
Group II
Active Comparator
One autologous transplant along with a second autologous transplant will be preformed followed by one year of observation.
Group III
Active Comparator
One autologous transplant and one non-myeloablative allogeneic transplant will be preformed and followed by one year of observation.
Study Objectives
Primary Objectives

Patients are considered a failure for this endpoint if they die or if they progress or relapse.
Secondary Objectives

The event is death from any cause, patients alive at the time of last observation are considered censored.

The event is death from any cause, patients alive at the time of last observation are considered censored.

Patients are considered experiencing an event when they progress. Deaths without progression are considered as a competing risk. Patients initiating non-protocol anti-myeloma therapy are considered to have progressed on this protocol.

TRM is defined as death occurring in a patient from causes other than relapse or progression.

Upon recovery from the first autograft, but at least 60 days (preferably between 60-120 days) after the first autograft, patients will receive a second transplant according to treatment assignments.

Incidence and severity of GVHD will be scored according to the BMT clinical trials network Manual of Procedures.

Incidence and severity of chronic GVHD will be scored according to the BMT clinical trials network Manual of Procedures.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 36 locations
Suspended
University of Alabama at BirminghamBirmingham, United StatesSee the location
Suspended
City of Hope SamaritanPhoenix, United States
Suspended
City of Hope National Medical CenterDuarte, United States
Suspended
Scripps Clinic/Green HospitalLa Jolla, United States
Completed36 Study Centers