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Multiple MyelomaPhase 1/2NCT00995059

Bortezomib Before Donor Stem Cell Transplant in Treating Patients With Multiple Myeloma

A Phase 1/2 study testing nonmyeloablative allogeneic hematopoietic stem cell transplantation, allogeneic bone marrow transplantation and bortezomib in people with Multiple Myeloma and Refractory Multiple Myeloma, run by Mayo Clinic.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Rationale: Giving bortezomib and low doses of chemotherapy and total-body irradiation before a donor stem cell transplant or peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Multiple Myeloma, Refractory Multiple Myeloma
What is being tested?
nonmyeloablative allogeneic hematopoietic stem cell transplantation, allogeneic bone marrow transplantation and bortezomib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Start not givento not given
Phase
Phase 1/2
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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ECOG performance status (PS) 0, 1, or 2
  • Diagnosis of symptomatic multiple myeloma
  • High risk myeloma as defined by progressive disease =< 12 months after high dose chemotherapy and autologous HSC transplant or presences of poor prognostic features such as deletion of chromosome 13 or hypodiploidy by standard cytogenetics, or t(4; 14) by fluorescence in situ hybridization (FISH), or t(14;16) by FISH, or 17p- by FISH, or plasma cell labeling index >= 3%
  • Availability of a HLA fully-matched or 1 mismatch related donor by low-resolution HLA typing for the loci A, B, C, DRB1 and DQB1 or HLA fully-matched unrelated donor by high-resolution typing for loci A, B, C and DRB1 and at least low-resolution for loci DQB1
  • Recovery from toxicity of previous chemotherapy (excludes grade 1 neurotoxicity and hematological toxicity)
  • Physically and psychologically capable of undergoing bone marrow or PBSC transplant
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  • 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
  • Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control for the during of the study
  • Male subject agrees to use an acceptable method for contraception for the duration of the study

Who cannot join

  • Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV hear failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
  • NOTE: Prior to study entry, and ECG abnormality at screening has to be documented by the investigator as not medically relevant
  • Significant cardiac dysfunction defined as left ventricle ejection fraction < 40% or presence of symptomatic coronary artery disease
  • Significant pulmonary disease defined as FEV < 50% or CLCO < 50% of the predicted values
  • Pre existing peripheral neuropathy grade > 1
  • Significant renal dysfunction defined as estimated creatinine clearance < 50 ml/min
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  • Significant liver dysfunction defined as total bilirubin >= 2 x upper limit of normal (ULN) or AST, ALT >= 3 x ULN
  • Seroreactive for HIV, HTLV I or II, HBV, HCV
  • Presence of uncontrolled bacterial, viral, or fungal infection
  • Known allergy to any of the component of the investigational treatment regimen or required ancillary treatments
  • Considered unable to tolerate the included doses of total body irradiation due to previous treatment with radiation
  • Female subject is pregnant or breast-feeding
  • Other active concurrent malignancy
  • Prior allogeneic bone marrow/peripheral blood stem cell transplant
  • Received other investigational drugs =< 14 days prior to enrollment

About this study

Official title: A Phase I/II Study of a Novel Reduced Intensity Conditioning Regimen for Allogeneic Stem Cell Transplantation in Patients With Multiple Myeloma

Rationale: Giving bortezomib and low doses of chemotherapy and total-body irradiation before a donor stem cell transplant or peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving sirolimus and tacrolimus before and after transplant may stop this from happening.

Purpose: This phase I/II trial is studying the side effects and best dose of bortezomib before donor stem cell transplant in treating patients with multiple myeloma.

Read the detailed description

Objectives:

  1. To determine the maximum tolerated dose (MTD) of bortezomib when used in a novel conditioning regimen for patients undergoing allogeneic stem cell transplantation for multiple myeloma.

II. To evaluate the tolerability and feasibility of this novel conditioning regimen and GVHD prophylaxis strategy incorporating several anti-myeloma agents, including bortezomib, in patients undergoing allogeneic stem cell transplantation for multiple myeloma.

III. To obtain an initial assessment of the efficacy of this novel conditioning regimen.

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

Reduced-Intensity Conditioning: Patients receive bortezomib IV and then undergo fractionated total-body irradiation on days -5 and -2. Patients receive thymoglobulin IV over 6 hours on days -5 to -2 and melphalan IV over 30 minutes on days -4 to -3.

Allogenic Stem Cell Transplantation: Patients undergo bone marrow or peripheral blood stem cell transplant on day 0.

Graft versus Host Disease Prophylaxis: Beginning on day -3, patients receive oral sirolimus and taper beginning on day 61. Beginning on day -2, patients receive oral or IV tacrolimus and taper beginning on day 101. After completion of the study treatment, patients are followed every 3 months.

Being tested
nonmyeloablative allogeneic hematopoietic stem cell transplantation, allogeneic bone marrow transplantation, bortezomib, melphalan, anti-thymocyte globulin
Keywords
stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma
Medical subject headings
Multiple Myeloma

What participants receive

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

  • nonmyeloablative allogeneic hematopoietic stem cell transplantationProcedure or surgery

    Undergo transplantation

  • allogeneic bone marrow transplantationProcedure or surgery

    Also called bone marrow therapy, allogeneic, bone marrow therapy, allogenic, transplantation, allogeneic bone marrow, transplantation, allogenic bone marrow

    Undergo transplantation

  • bortezomibDrug

    Also called LDP 341, MLN341, PS-341, VELCADE

    Given IV

  • melphalanDrug

    Also called Alkeran, CB-3025, L-PAM, L-phenylalanine mustard

    Given IV

  • anti-thymocyte globulinDrug

    Also called ATG, ATGAM, lymphocyte immune globulin, Thymoglobulin

    Given IV

  • sirolimusDrug

    Also called AY 22989, RAPA, Rapamune, rapamycin

    Given orally

  • tacrolimusDrug

    Also called Advagraf, FK 506, Prograf, Protopic

    Given oral or IV

  • total-body irradiationRadiation

    Also called TBI

    Undergo total-body irradiation

Study groups in NCT00995059
Study groupRoleWhat they receive
Arm 1ExperimentalCONDITIONING: Patients receive bortezomib IV and then undergo fractionated total-body irradiation on days -5 and -2. Patients receive thymoglobulin IV over 6 hours on days -5 to -2 and melphalan IV over 30 minutes on days -4 to -3. ALLOGENEIC STEM CELL TRANSPLANTATION: Patients undergo bone marrow or peripheral blood stem cell transplant on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Beginning on day -3, patients receive oral sirolimus and taper beginning on day 61. Beginning on day -2, patients receive oral or IV tacrolimus and taper beginning on day 101.
Receives: Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation; Procedure: allogeneic bone marrow transplantation; Drug: bortezomib; Drug: melphalan; Drug: anti-thymocyte globulin; Drug: sirolimus; Drug: tacrolimus; Radiation: total-body irradiation

What is being measured

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

  1. Tolerability as assessed by CTCAE v3.0 (Phase I)

  2. Assessment of toxicity (Phase I)

  3. Proportion of successes

  4. Transplant-related mortality (TRM) (Phase II)

    Measured: 100 days

  5. Rate acute graft-vs-host disease (GVHD) (Phase I)

Secondary outcomes (5)

  1. Rate of grades II-IV and grades III-IV acute graft-vs-host disease (GVHD)

  2. Cumulative rate of chronic GVHD

  3. Overall response

  4. Overall survival

  5. Progression-free survival

Timeline

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

  1. First posted14 Oct 2009 (estimated)

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00995059
Sponsor's protocol ID
MC078F
Other IDs
NCI-2009-01249, 08-003029, MC078F
Status last verified
Feb 2011
First submitted
12 Oct 2009
Last updated
5 Jan 2023
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing nonmyeloablative allogeneic hematopoietic stem cell transplantation, allogeneic bone marrow transplantation and bortezomib in people with Multiple Myeloma and Refractory Multiple Myeloma, run by Mayo Clinic.

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 9 inclusion and 15 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: withdrawn, as of the sponsor's last update on 5 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

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 combined 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.

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 was withdrawn before enrolling participants, so there are no results.

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?

Tolerability as assessed by CTCAE v3.0 (Phase I). The study lists 5 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 NCT00995059.

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 5 Jan 2023.

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