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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

Phase 1
18 Years
Open (Enrolling)
Multiple Myeloma

Thank you

Trial Information

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

Inclusion Criteria:

- 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

- 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:

- 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

- 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

- Patients must agree to follow all guidelines from the RevAssist® Program

Exclusion Criteria:

- 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

- 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.

- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

during study

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

December 2009

Completion Date:

July 2013

Related Keywords:

  • Multiple Myeloma
  • relapsed or relapsed/refractory multiple myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



Roswell Park Cancer InstituteBuffalo, New York  14263
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Florida Cancer SpecialistsFort Myers, Florida  33901
Duke University Medical CenterDurham, North Carolina  27710
University of Southern CaliforniaLos Angeles, California  90033
Sarah Cannon Research InstituteNashville, Tennessee  37203
Comprehensive Cancer Center of the DesertPalm Springs, California  92262
Weill Medical CollegeNew York, New York  10021
CTRC at University of Texas Health Science CenterSan Antonio, Texas  78229