Multiple Myeloma and Plasma Cell NeoplasmPhase 2NCT00635024
Anti-thymocyte Globulin and Melphalan in Treating Patients With Relapsed Multiple Myeloma
A Phase 2 study testing anti-thymocyte globulin and melphalan in people with Multiple Myeloma and Plasma Cell Neoplasm, run by Mayo Clinic at 1 site in United States.
Trial summary
RATIONALE: Biological therapies, such as anti-thymocyte globulin, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from… Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Multiple Myeloma and Plasma Cell Neoplasm
- What is being tested?
- anti-thymocyte globulin and melphalan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Nov 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of multiple myeloma
- Relapsed disease
- Must not be a candidate for stem cell transplantation, has refused transplantation, or has had stem cells collected previously
- Measurable disease, defined by ≥ 1 of the following:
- Serum monoclonal protein ≥ 1.0 g by protein electrophoresis
- More than 200 mg of monoclonal protein in the urine on 24 hour electrophoresis
- Serum immunoglobulin free light chain ≥ 10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio
- Monoclonal bone marrow plasmacytosis ≥ 30% (evaluable disease)
PATIENT CHARACTERISTICS:
- Eastern Cooperative Oncology Group (ECOG) performance status 0-3
- Absolute neutrophil count ≥ 1,000/μL
- Platelet count ≥ 75,000/μL
- Hemoglobin ≥ 8.0 g/dL
- CD4 > 100/μL
- Creatinine ≤ 3 mg/dL
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No active malignancy with the exception of nonmelanoma skin cancer or in situ cervical or breast cancer
- No uncontrolled infection
- No other co-morbidity that would interfere with patient's ability to participate in trial
PRIOR CONCURRENT THERAPY:
- No limit to prior therapy
- At least 4 weeks since prior melphalan or other myelosuppressive agents
- At least 2 weeks since prior non-myelosuppressive agents (e.g., thalidomide or high-dose corticosteroids)
- No concurrent high-dose corticosteroids
- Concurrent chronic steroids (maximum dose 20 mg/day prednisone equivalent) allowed if they are being given for disorders other than amyloid (e.g., adrenal insufficiency or rheumatoid arthritis)
- Concurrent continuation of low level/stable steroid doses for replacement or inhalation therapy allowed
- Concurrent bisphosphonates allowed
- No concurrent immunosuppressive medications such as cyclosporine
- No other concurrent investigational treatment
- No concurrent cytotoxic chemotherapy or external-beam radiotherapy>
- No other concurrent systemic anti-neoplastic therapy including, but not limited to, immunotherapy, hormonal therapy, or monoclonal antibody therapy
- No concurrent prophylactic hematopoietic growth factors (unless for treatment of an established cytopenia)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Trial of Thymoglobulin and Melphalan in Patients With Relapsed Multiple Myeloma
RATIONALE: Biological therapies, such as anti-thymocyte globulin, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Anti-thymocyte globulin may also make cancer cells more sensitive to melphalan. Giving anti-thymocyte globulin together with melphalan may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving anti-thymocyte globulin together with melphalan works in treating patients with relapsed multiple myeloma.
Read the detailed description
OBJECTIVES:
Primary
- To evaluate the hematological response rate of anti-thymocyte globulin given in combination with melphalan in patients with relapsed multiple myeloma.
Secondary
- To assess the toxicity and tolerability of this combination in these patients.
- To assess time to disease progression in patients treated with these drugs.
- To assess survival of patients treated with these drugs. OUTLINE: Patients receive anti-thymocyte globulin IV over 6 hours and melphalan IV on day 1. Treatment repeats every 28 days for 6 courses. Patients then receive melphalan alone as above for another 6 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 2 years.
- Being tested
- anti-thymocyte globulin, melphalan
- Keywords
- refractory multiple myeloma, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma
- Medical subject headings
- Multiple Myeloma, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-thymocyte globulinBiological
2.5 mg/kg
melphalanDrug
16 mg/m^2
| Study group | Role | What they receive |
|---|---|---|
| Anti-thymocyte Globulin/Melphalan | Experimental | Anti-thymocyte Globulin (2.5 mg/Kg)and Melphalan (16 mg/m^2) Receives: Biological: anti-thymocyte globulin; Drug: melphalan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hematological Response Rate Defined as the Number of Participants Who Achieve a Confirmed Response
Response that was confirmed on 2 consecutive evaluations during the first 4 months of treatment.
Complete Response(CR): Disappearance of M-protein from serum and urine, normalization of Free Light Chain (FLC) ratio and <5% plasma cells in bone marrow.
Very Good Partial Response(VGPR): >=90% reduction in serum M-component; Urine M-Component <100mg per 24hours.
Partial Response(PR): >=50% reduction in serum M-component and/or Urine M-Component >=90% reduction or <200mg per 24hours; or >=50% decrease in difference between involved and uninvolved FLC levels.
Measured: 4 months
Secondary outcomes (4)
Overall Survival (OS)
OS was defined as the time from registration to death of any cause.
Measured: up to 2 years
Progression-free Survival (PFS)
PFS was defined as the time from registration to progression or death due to any cause.
Progression was defined as any one or more of the following:
An increase of 25% from lowest confirmed response in:
- Serum M-component (absolute increase >= 0.5g/dl)
- Urine M-component (absolute increase >= 200mg/24hour
- Difference between involved and uninvolved Free Light Chain levels (absolute increase >= 10mg/dl)
- Bone marrow plasma cell percentage (absolute increase of >=10%)
- Definite development of new bone lesion or soft tissue plasmacytomas
Measured: up to 2 years
Duration of Response (DOR)
DOR was calculated from the documentation of response (CR, VGPR or PR) until the date of progression in the subset of patients who responded.
Measured: up to 2 years
Number of Participants With Severe Non-hematological Adverse Events
Severe non-hematologic adverse events were defined as adverse events grade 3 or higher, regardless of attribution to study drug. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE version 3.0)
Measured: every month during treatment, up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2008 (estimated)
- Study startMay 2008
- Primary completionJul 2008
- Study completionNov 2010
Why it stopped: Due to competing trials, this study is permanenlty closed to patient acrrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple Myeloma and Plasma Cell NeoplasmStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Shaji K. Kumar, MD, Study chair, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00635024
- Sponsor's protocol ID
- CDR0000589032
- Other IDs
- P30CA015083, MC0687, 06-005792
- Status last verified
- Aug 2011
- First submitted
- 12 Mar 2008
- Last updated
- 10 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Thymoglobulin and Melphalan in Patients With Relapsed Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00635024
- Acronym / sponsor ID
- CDR0000589032
- Keywords
- refractory multiple myeloma, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to competing trials, this study is permanenlty closed to patient acrrual.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2008
- Primary completion
- Jul 2008 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 13 Mar 2008 (estimated)
- Results
- Posted 18 Oct 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Biological therapies, such as anti-thymocyte globulin, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Anti-thymocyte globulin may also make cancer cells more sensitive to melphalan. Giving anti-thymocyte globulin together with melphalan may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving anti-thymocyte globulin together with melphalan works in treating patients with relapsed multiple myeloma.
Detailed description
OBJECTIVES:
Primary
- To evaluate the hematological response rate of anti-thymocyte globulin given in combination with melphalan in patients with relapsed multiple myeloma.
Secondary
- To assess the toxicity and tolerability of this combination in these patients.
- To assess time to disease progression in patients treated with these drugs.
- To assess survival of patients treated with these drugs. OUTLINE: Patients receive anti-thymocyte globulin IV over 6 hours and melphalan IV on day 1. Treatment repeats every 28 days for 6 courses. Patients then receive melphalan alone as above for another 6 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anti-thymocyte Globulin/Melphalan | Experimental | Biological: anti-thymocyte globulin, Drug: melphalanAnti-thymocyte Globulin (2.5 mg/Kg)and Melphalan (16 mg/m^2) |
Who may qualify
- Ages
- 18 to 120 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 |
|---|---|---|
| anti-thymocyte globulin2.5 mg/kg | Biological | Anti-thymocyte Globulin/Melphalan |
| melphalan16 mg/m^2 | Drug | Anti-thymocyte Globulin/Melphalan |
Primary outcome
Hematological Response Rate Defined as the Number of Participants Who Achieve a Confirmed Response
Time frame: 4 months
Response that was confirmed on 2 consecutive evaluations during the first 4 months of treatment. Complete Response(CR): Disappearance of M-protein from serum and urine, normalization of Free Light Chain (FLC) ratio and <5% plasma cells in bone marrow. Very Good Partial Response(VGPR): >=90% reduction in serum M-component; Urine M-Component <100mg per 24hours. Partial Response(PR): >=50% reduction in serum M-component and/or Urine M-Component >=90% reduction or <200mg per 24hours; or >=50% decrease in difference between involved and uninvolved FLC levels.
4 secondary outcomes
Overall Survival (OS)
Time frame: up to 2 years
Progression-free Survival (PFS)
Time frame: up to 2 years
Duration of Response (DOR)
Time frame: up to 2 years
Number of Participants With Severe Non-hematological Adverse Events
Time frame: every month during treatment, up to 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Multiple Myeloma and Plasma Cell Neoplasm
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.
Shaji K. Kumar, MD study chair
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing anti-thymocyte globulin and melphalan in people with Multiple Myeloma and Plasma Cell Neoplasm, run by Mayo Clinic at 1 site 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: stopped early, as of the sponsor's last update on 10 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 18 Oct 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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.
What does the primary outcome measure?
Hematological Response Rate Defined as the Number of Participants Who Achieve a Confirmed Response (time frame: 4 months). It is what the study was designed to measure, not a finding.
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 10 Feb 2017.