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DS Stage I Plasma Cell MyelomaPhase 1NCT01936090

Bortezomib, Melphalan, and Total-Body Irradiation Before Stem Cell Transplant in Treating Patients With Multiple Myeloma

A Phase 1 study testing Bortezomib, Total-Body Irradiation and Melphalan in people with DS Stage I Plasma Cell Myeloma and DS Stage II Plasma Cell Myeloma, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This phase I/II trial studies the side effects and best dose of bortezomib when given together with melphalan, and total-body irradiation before stem cell transplant and to see how well it works in treating patients with multiple myeloma. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Bortezomib, Total-Body Irradiation and Melphalan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
1 siteUnited States
Study dates
Aug 2013to 16 Feb 2018
Phase
Phase 1
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Serum creatinine =< 2 mg/dL
  • Serum total bilirubin =< 1.5 X upper limit of normal (ULN)
  • Platelet count >= 30,000/μL
  • Hemoglobin >= 8.0 g/dL
  • Diagnosis of myeloma for which autologous stem cell transplant is being considered
  • Measurable disease of multiple myeloma at the time of baseline values for disease assessment as defined by at least one of the following:
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  • Serum monoclonal protein >= 1.0 g/dL
  • >= 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
  • Bone marrow plasma cells >= 30%
  • NOTE:
  • For patients with no relapse prior to transplant, measurable disease at the time of diagnosis
  • For patients who have had a disease relapse prior to transplant, measurable disease at the time of the most recent relapse immediately prior to transplant.
  • If the patient had treatment for the relapsed disease prior to transplant, the patient must have measurable disease at the time of relapse prior to this therapy
  • Patient is considered for autologous stem cell transplantation with full dose melphalan (200 mg/m^2)
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
  • Recovered from non-hematological toxicity of previous chemotherapy (excludes grade 1 neurotoxicity)
  • Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
  • Ejection fraction >= 45%
  • Corrected pulmonary diffusion capacity of greater than or equal to 50%
  • Forced expiratory volume in one second (FEV1) >= 50%
  • Forced vital capacity (FVC) >= 50%
  • Negative pregnancy test performed =< 14 days prior to registration, for women of childbearing potential only
  • Willing to return to Mayo Clinic Rochester, for treatment and follow-up
  • Note: During the Active Monitoring Phase of a study (i.e., active treatment and observation), participants must be willing to return to the consenting institution for follow-up
  • Willing to provide blood and bone marrow samples for correlative research purposes

Who cannot join

  • Prior autologous or allogeneic bone marrow/peripheral blood stem cell transplant
  • More than two prior regimens for therapy of MM
  • Myocardial infarction within 6 months prior to enrollment, or has New York Heart Association (NYHA) class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities; NOTE: prior to study entry, any electrocardiogram (ECG) abnormality at screening has to be documented by the investigator as not medically relevant
  • Seroreactivity for human immunodeficiency virus (HIV), human T-cell lymphotrophic virus (HTLV) I or II, hepatitis B virus (HBV), hepatitis C virus (HCV)
  • Other active malignancy < 2 years prior to registration; EXCEPTIONS: non-melanotic skin cancer or carcinoma-in-situ of the cervix or low-risk prostate cancer after curative therapy
  • NOTE: If there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer
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  • Any of the following:
  • Pregnant women or women of reproductive capability who are unwilling to use effective contraception (2 effective methods of contraception, at the same time) from the time of signing the informed consent through 30 days after the last dose of study treatment, OR unwilling to agree to completely abstain from heterosexual intercourse
  • Nursing women
  • Men who are unwilling to use a condom (even if they have undergone a prior vasectomy) while having intercourse with any woman, while taking the drug and for 30 days after stopping treatment
  • Unwilling to agree to completely abstain from heterosexual intercourse
  • Other co-morbidity, which would interfere with patient's ability to participate in the trial, e.g. uncontrolled infection, uncompensated lung disease or psychiatric illness
  • Concurrent chemotherapy, radiotherapy, or any ancillary therapy considered investigational; NOTE: bisphosphonates are considered to be supportive care rather than therapy, and are thus allowed while on protocol treatment
  • Known allergies to any of the components of the investigational treatment regimen or required ancillary treatments
  • Patient has >= grade 2 peripheral neuropathy
  • Participation in clinical trials with other investigational agents not included in this trial, within 14 days of the start of this trial and throughout the duration of this trial

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: Phase I/II Bortezomib, Melphalan and Low Dose TBI Conditioning for Patients Undergoing Autologous Stem Cell Transplantation for Multiple Myeloma

This phase I/II trial studies the side effects and best dose of bortezomib when given together with melphalan, and total-body irradiation before stem cell transplant and to see how well it works in treating patients with multiple myeloma. Giving chemotherapy and total-body irradiation before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. The stem cells that were collected from the patient's blood or bone marrow are returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy and total-body irradiation.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine the maximum tolerated dose (MTD) of bortezomib that can be added to high dose melphalan and low dose total body irradiation as part of conditioning chemotherapy for myeloma. (Phase I) II. To determine the efficacy of the bortezomib added to high dose melphalan and low dose total-body irradiation (TBI) in patients with myeloma undergoing stem cell transplantation, as defined by achievement of complete response (CR). (Phase II)

SECONDARY OBJECTIVES:

  1. To examine the toxicities associated with addition of bortezomib to high dose melphalan and TBI in patients with multiple myeloma (MM).

II. To determine the progression free rate at 1 and 2 years.

TERTIARY OBJECTIVES:

  1. To determine the proportion of patients achieving a minimal residual disease (MRD) negative status.

II. To assess the HevyLite assay prior to and during treatment.

OUTLINE: This is a phase I, dose-escalation study of bortezomib followed by a phase II study.

CONDITIONING REGIMEN: Patients receive bortezomib intravenously (IV) on days -5 and -2, TBI twice daily (BID) on days -5 and -2, and melphalan IV over 1 hour on days -4 and -3.

TRANSPLANT: Patients undergo autologous bone marrow or peripheral blood stem cell transplant on day 0.

After completion of study treatment, patients are followed up at 100 days and then every 90 days for up to 3 years.

Being tested
Bortezomib, Total-Body Irradiation, Melphalan, Autologous Bone Marrow Transplantation, Autologous Hematopoietic Stem Cell Transplantation
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BortezomibDrug

    Given IV

  • Total-Body IrradiationRadiation

    Also called TBI, Total Body Irradiation, Whole-Body Irradiation

    Undergo TBI

  • MelphalanDrug

    Also called Alkeran

    Given IV

  • Autologous Bone Marrow TransplantationProcedure or surgery

    Also called ABMT, Autologous Bone Marrow Transplant, Autologous Marrow Transplantation

    Undergo autologous bone marrow transplant

  • Autologous Hematopoietic Stem Cell TransplantationProcedure or surgery

    Also called Autologous Stem Cell Transplantation

    Undergo autologous peripheral blood stem cell transplant

  • Peripheral Blood Stem Cell TransplantationProcedure or surgery

    Also called PBPC transplantation, Peripheral Blood Progenitor Cell Transplantation, Peripheral Stem Cell Support, Peripheral Stem Cell Transplantation

    Undergo autologous peripheral blood stem cell transplant

  • Laboratory Biomarker AnalysisOther

    Correlative studies

Study groups in NCT01936090
Study groupRoleWhat they receive
Treatment (bortezomib, TBI, melphalan, stem cell transplant)ExperimentalConditioning regimen: Patients receive bortezomib IV on days -5 and -2, TBI BID on days -5 and -2, and melphalan IV over 1 hour on days -4 and -3. Transplant: Patients undergo autologous bone marrow or peripheral blood stem cell transplant on day 0.
Receives: Drug: Bortezomib; Radiation: Total-Body Irradiation; Drug: Melphalan; Procedure: Autologous Bone Marrow Transplantation; Procedure: Autologous Hematopoietic Stem Cell Transplantation; Procedure: Peripheral Blood Stem Cell Transplantation; Other: Laboratory Biomarker Analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MTD defined as the dose level below the lowest dose that induces dose-limiting toxicity in at least one-third of patients (phase I)

    Measured: Day 36

  2. The number and severity of all adverse events (phase I)

    Will be tabulated and summarized in this patient population. The grade 3+ adverse events will also be described and summarized in a similar fashion.

    Measured: Up to 3 years

  3. Proportion of complete responses (CR) defined as a CR noted as the objective status on two consecutive evaluations (phase II)

    Will be tabulated and summarized in this patient population. The grade 3+ adverse events will also be described and summarized in a similar fashion. 95% confidence intervals for the true success proportion will be calculated.

    Measured: Up to 3 years

Secondary outcomes (4)

  1. CR rate at day 100 estimated by the total number of patients who achieve a complete CR by day 100 post-transplant divided by the total number of evaluable patients

    Exact binomial 95% confidence intervals for the true CR rate at day 100 will be calculated.

    Measured: At day 100

  2. Time to progression

    Will be estimated using the method of Kaplan-Meier.

    Measured: Time from registration to the earliest date with documentation of disease progression, assessed at 1 year

  3. Time to progression

    Will be estimated using the method of Kaplan-Meier.

    Measured: Time from registration to the earliest date with documentation of disease progression, assessed at 2 years

  4. Maximum grade for each type of adverse event

    Will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration.

    Measured: Up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Sep 2013 (estimated)
  2. Study startAug 2013
  3. Primary completion2 Feb 2016
  4. Study completion16 Feb 2018

Resources

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01936090
Sponsor's protocol ID
MC1286
Other IDs
NCI-2013-01646, Mod12-008546-08, MC1286, P30CA015083
Status last verified
May 2018
First submitted
1 Sep 2013
Last updated
24 May 2018
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Bortezomib, Total-Body Irradiation and Melphalan in people with DS Stage I Plasma Cell Myeloma and DS Stage II Plasma Cell Myeloma, 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?

The sponsor lists 26 inclusion and 16 exclusion criteria. 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 24 May 2018. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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.

What does the primary outcome measure?

MTD defined as the dose level below the lowest dose that induces dose-limiting toxicity in at least one-third of patients (phase I) (time frame: Day 36). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01936090.

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 24 May 2018.

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