Multiple MyelomaPhase 2NCT00078065
Xcellerated T CellsTM in Patients With Multiple Myeloma
A Phase 2 study testing Xcellerated T Cells in people with Multiple Myeloma, run by Xcyte Therapies at 9 sites in United States.
Trial summary
This trial is a phase II, randomized study of patients with multiple myeloma. All patients will receive Xcellerated T Cells, with or without prior fludarabine therapy. 15 patients in each study arm will be followed for 6 months. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Xcellerated T Cells
- How many people
- 30 participants
- Where
- 9 sitesUnited States
- Study dates
- Nov 2003to Jun 2004
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
- Previous diagnosis of multiple myeloma (MM) based on standard criteria. Tests need not be performed within 30 days of registration.
- Failure of at least one, but no more than four, prior systemic therapies for MM prior to registration and may not have relapsed or progressed within 1 year following autologous hematopoietic stem cell transplantation. Repeat courses of the same therapeutic regimen separated in time by 6 or more months are considered separate therapies. Induction therapy followed by high dose chemotherapy and autologous hematopoietic stem cell transplantation counts as one therapy.
- Measurable serum and/or urine M-protein
- Disease progression or relapse, since most recent therapy for multiple myeloma
- Age > 18 years old and < 75 years old
- ECOG performance status of 0 or 1
- Females of child-bearing potential must have a negative serum bHCG test and be willing to use effective contraception (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the trial
- Negative test results for current/active infection with HIV-1, HIV-2, HTLV-1, HTLV-2, hepatitis B, and hepatitis C within 30 days of registration (Antibody, antigen, and nucleic acid tests acceptable, depending on institutional standards)
- Hemoglobin >= 10.0 g/dL. Transfusion with red blood cells or use of erythropoietin is permissible.
- White blood count (WBC) >= 3,000/mm3 and absolute neutrophil count (ANC) > 1000/mm3
- Platelet count > 75,000/mm3
- Corrected serum calcium < 11 mg/dL, and no evidence of symptomatic hypercalcemia. (Corrected serum calcium is calculated by adding 0.8 mg/dL to the measured serum calcium for every 1 g/dL that the serum albumin falls below 4.0 g/dL)
- Serum total bilirubin and alanine aminotransferase (ALT) < 2.0 times the upper limit of normal
- Serum creatinine < 2.5 mg/dL
- Serum human anti-mouse antibody (HAMA) titer undetectable or within the normal range, and no history of allergies to mice or murine (mouse) proteins
- The patient must be able to comprehend and have signed the informed consent
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Johns Hopkins Medical Institute
Baltimore, Maryland, 21231
Center for Cancer & Blood Disorders
Bethesda, Maryland, 20817
Cancer Centers of the Carolinas
Greenville, South Carolina, 29605
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Oncotherapeutics
Los Angeles, California, 90067
Oregon Health Sciences University
Portland, Oregon, 97239
University of California, San Diego
San Diego, California, 92093
University of California, San Francisco
San Francisco, California, 94143
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: A Randomized Phase II Study of Xcellerated T CellsTM With or Without Prior Fludarabine Therapy in Patients With Multiple Myeloma
This trial is a phase II, randomized study of patients with multiple myeloma. All patients will receive Xcellerated T Cells, with or without prior fludarabine therapy.
15 patients in each study arm will be followed for 6 months.
Read the detailed description
This randomized Phase II clinical study is designed to examine the safety and efficacy of Xcellerated T CellsTM, an activated, autologous T cell product, in subjects with multiple myeloma. Subjects must have failed at least one, but no more than three, prior cytotoxic therapies prior to study registration and may not have relapsed or progressed within one year following hematopoietic stem cell transplantation. Patients will be randomized to treatment with either Xcellerated T Cells alone, or lymphoablative therapy with fludarabine followed by Xcellerated T Cells. Thirty subjects will be treated, with 15 patients in each arm. Patients will be followed for six months following treatment.
- Conditions
- Multiple Myeloma
- Being tested
- Xcellerated T Cells
- Keywords
- multiple myeloma, fludarabine, Xcellerated T Cells
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xcellerated T CellsDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2004 (estimated)
- Study startNov 2003
- Study completionJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Xcyte Therapies
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mark W Frohlich, MD, Study chair, Xcyte Therapies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00078065
- Sponsor's protocol ID
- XT005
- Status last verified
- Mar 2005
- First submitted
- 18 Feb 2004
- Last updated
- 11 Nov 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Study of Xcellerated T CellsTM With or Without Prior Fludarabine Therapy in Patients With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00078065
- Acronym / sponsor ID
- XT005
- Conditions
- Multiple Myeloma
- Keywords
- multiple myeloma, fludarabine, Xcellerated T Cells
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- Xcyte TherapiesIndustry (pharma, biotech, devices)
- Study start
- Nov 2003
- Study completion
- Jun 2004
- First posted
- 20 Feb 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is a phase II, randomized study of patients with multiple myeloma. All patients will receive Xcellerated T Cells, with or without prior fludarabine therapy.
15 patients in each study arm will be followed for 6 months.
Detailed description
This randomized Phase II clinical study is designed to examine the safety and efficacy of Xcellerated T CellsTM, an activated, autologous T cell product, in subjects with multiple myeloma. Subjects must have failed at least one, but no more than three, prior cytotoxic therapies prior to study registration and may not have relapsed or progressed within one year following hematopoietic stem cell transplantation. Patients will be randomized to treatment with either Xcellerated T Cells alone, or lymphoablative therapy with fludarabine followed by Xcellerated T Cells. Thirty subjects will be treated, with 15 patients in each arm. Patients will be followed for six months following treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xcellerated T Cells | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2005.
Related trials for Multiple Myeloma
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark W Frohlich, MD study chair
Xcyte Therapies
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Xcellerated T Cells in people with Multiple Myeloma, run by Xcyte Therapies at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Nov 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2005.