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Multiple MyelomaPhase 1NCT00991562

IMGN901 in Combination With Lenalidomide and Dexamethasone

A Phase 1 study testing IMGN901 in people with Multiple Myeloma, run by ImmunoGen, Inc. at 9 sites 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

The purpose of this study is to test IMGN901 in combination with lenalidomide and dexamethasone every 28 days. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
IMGN901
How many people
50 participants
Where
9 sitesUnited States
Study dates
Dec 2009to Oct 2014
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

  • Diagnosis of multiple myeloma based on standard criteria.
  • Patients must have CD56-positive, relapsed or relapsed/refractory multiple myeloma. Myeloma is considered CD56-positive if either immunohistochemistry (IHC) or flow cytometry criteria defined in Appendix X are met.
  • Age < 18 years at the time of signing Informed Consent.
  • Patients have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
  • During the dose escalation phase, patients must have received at least one prior therapy for multiple myeloma. The prior therapy or therapies can include lenalidomide treatment.
  • Once the MTD/RPTD is defined, only patients who have received at least 1 but no more than 3 prior chemotherapy regimens will be enrolled at this dose level in the study. Prior regimen(s) may have included bortezomib or a bortezomib component. If prior regimen(s) included a lenalidomide component:
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  • Patients last dose of lenalidomide must be ≥ 6 months from Day 1 treatment with BB-10901 (with the exception of maintenance lenalidomide treatment which should be completed at least 4 weeks prior to Day 1 treatment with BB-10901) ,
  • Patients must have achieved a response of stable disease or better to any lenalidomide treatment, and
  • Patients must not have discontinued treatment due to lenalidomide intolerance.
  • Patients must be able to adhere to the study visit schedule and other protocol requirements.
  • Patients must understand and voluntarily sign an informed consent document.
  • Woman of child bearing potential (WCBP) must have a negative pregnancy test within 10 - 14 days and within 24 hours prior to writing an initial prescription for lenalidomide even if continuous abstinence is the chosen method of birth control. In addition, all sexually active WCBP must agree to frequent pregnancy tests as outlined in the protocol and must agree to use 2 contraceptive methods. WCBP must agree to follow these requirements for at least 4 weeks before beginning treatment with lenalidomide and for at least 4 weeks after the last treatment of lenalidomide.
  • Male patients must agree to use a latex condom even if he has had a successful vasectomy and males can not donate sperm. Males must agree to follow these requirements for at least 4 weeks following last dose of study drug.
  • Patients may have received chemotherapy or wide-field radiotherapy (e.g. .30% of marrow-bearing bones) if completed at least 4 weeks prior to Day 1, or focal radiation completed at least 2 weeks prior to Day 1, and the patient has recovered or stabilized from all adverse effects of such therapy. Therapy with nitrosoureas or mitomycin C must be completed 6 weeks prior to Day 1. Major surgery (this does not include placement of vascular access device or tumor biopsies) must be completed 4 weeks prior to Day 1. Antineoplastic therapy with biological agents must be completed at least 2 weeks prior to Day 1.
  • Absolute neutrophil count (ANC) ≥ 1000 cells/mm3, hemoglobin ≥ 8.5 g/dL, and platelet count ≥ 50,000/mm3
  • Aspartate aminotransferase(AST) (serum glutamic oxalacetic transaminase, SGOT) and alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase, SGPT) ≤ 3 x upper limit of normal (ULN) and total bilirubin ≤ 1.5 x ULN
  • Amylase and lipase levels must be ≤ 1.5 x ULN.
  • Serum Creatinine ≤ 1.5 x ULN
  • Left ventricular ejection fraction ≥ lower limit of normal (LLN) on MUGA scan or ECHO.
  • Patients must agree to follow all guidelines from the RevAssist® Program

Who cannot join

  • Concomitant therapy with other antineoplastic treatments (chemotherapy, radiotherapy or biological agents) during the study.
  • Peripheral neuropathy of grade 2 or greater.
  • Known hypersensitivity to lenalidomide or other thalidomide derivatives, previous monoclonal antibody therapy or maytansinoids.
  • History of deep venous thrombus or pulmonary embolism within 6 months of study enrollment.
  • Any serious medical condition, laboratory abnormalities, or psychiatric disorder, that in the opinion of the Investigator places the patients at unacceptable risk if he/she were to participate in the study.
  • Clinically relevant active infection including active hepatitis B or C, Human Immunodeficiency Virus (HIV) infection, or any other concurrent disease which, in the judgment of the Investigator, would make the patients inappropriate for enrollment into this study.
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  • Significant cardiac disease such as recent myocardial infarction (≤ 6 months prior to Day 1), unstable angina, uncontrolled congestive heart failure, uncontrolled hypertension (recurrent or persistent increases in systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg ), uncontrolled cardiac arrhythmias, grade 3 or greater cardiac toxicity following prior chemotherapy.
  • History of multiple sclerosis or other demyelinating disease, Eaton-Lambert syndrome (para-neoplastic syndrome), history of hemorrhagic or ischemic stroke within the last 6 months, central nervous system (CNS) injury with residual neurological deficit, or alcoholic liver disease.
  • Treatment with another investigational agent during the study or ≤ 4 weeks prior to Day 1.
  • Prior malignancy within the last 3 years except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, in situ prostate cancer.
  • Patients who have any known recent biochemical or clinical evidence of pancreatitis or extensive metastatic disease involving the pancreas that is associated with an increased amylase and/or lipase will be excluded. (Note: Enrollment of patients with any metastatic disease to, or around, the pancreas may be allowed only with agreement between the Sponsor and the Investigator).
  • WCBP who are pregnant or breast feeding or men and women not using adequate contraception are excluded.
  • Patients unwilling or unable to comply with the requirements of the study.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • University of Southern California

    Los Angeles, California, 90033

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Weill Medical College

    New York, New York, 10021

  • Comprehensive Cancer Center of the Desert

    Palm Springs, California, 92262

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • CTRC at University of Texas Health Science Center

    San Antonio, Texas, 78229

  • Florida Cancer Specialists

    Sarasota, Florida, 34232

Other trials in United States

About this study

Official title: An Open-Label Phase I Study of Bb-10901 (IMGN901, huN901-DM10 in Combination With Lenalidomide and Dexamethasone in Patients With CD56-positive Relapsed or Relapsed/Refractory Multiple Myeloma

The purpose of this study is to test IMGN901 in combination with lenalidomide and dexamethasone every 28 days.

Being tested
IMGN901
Keywords
relapsed or relapsed/refractory multiple myeloma
Medical subject headings
Multiple Myeloma, Recurrence

What participants receive

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

  • IMGN901Drug

    Also called BB-10901, huN901-DM1

    dose escalation study. dosing on days 1, 8 and 15 every 28 days

What is being measured

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

  1. Determine the MTD/RPTD and response rate To assess the response rate of the combination at the MTD, in the patient population

    Measured: during study

Secondary outcomes (1)

  1. Objective response rate (OR and CR), duration of responses, time to progression, progression-free survival, and overall survival and pharmacodynamics.

    Measured: during the study

Timeline

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

  1. First posted8 Oct 2009 (estimated)
  2. Study startDec 2009
  3. Primary completionAug 2013
  4. Study completionOct 2014

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
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00991562
Sponsor's protocol ID
IMGN0005
Status last verified
Nov 2014
First submitted
7 Oct 2009
Last updated
21 Nov 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IMGN901 in people with Multiple Myeloma, run by ImmunoGen, Inc. 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?

The sponsor lists 20 inclusion and 13 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 21 Nov 2014. 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 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?

Determine the MTD/RPTD and response rate To assess the response rate of the combination at the MTD, in the patient population (time frame: during study). 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 NCT00991562.

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 21 Nov 2014.

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Clinical Trial NCT00991562 | AzTrials