Multiple MyelomaPhase 1/2NCT01638936
BT062 in Combination With Lenalidomide or Pomalidomide and Dexamethasone in Patients With Multiple Myeloma
A Phase 1/2 study testing BT062 , intravenous administration in people with Multiple Myeloma, run by Biotest Pharmaceuticals Corporation at 10 sites in United States.
Trial summary
The purpose of this study is to test safety and anti-tumor activity of BT062 in combination with lenalidomide and dexamethasone to define the best doses for treating patients with relapsed and refractory multiple myeloma. 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?
- BT062 , intravenous administration
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 10 sitesUnited States
- Study dates
- 3 Jul 2012to 30 Oct 2018
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of active Multiple Myeloma according to the International Myeloma Working Group (IMWG) diagnostic criteria
- Relapsed or relapsed/refractory progressive Multiple Myeloma
- Subjects who failed at least one prior therapy (BT062/Len/dex)
- Subjects who failed at least two prior therapy (BT062/Pom/dex)
- Subjects age ≥18 years
- Life expectancy of ≥12 weeks
Show all 11Show fewer
- Eastern Cooperative Oncology Group (ECOG) performance status (Zubrod) ≤2
- Normal organ and bone marrow
- Signed written informed consent in accordance with federal, local, and institutional guidelines
- Subjects must agree to follow all Guidelines from REVLIMID REMS Program or POMALYST REMS
- Women of child bearing potential (WCBP), must agree to use 2 contraceptive methods
Who cannot join
- Chemotherapy or radiotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to day 1 or those who have not recovered from adverse events (AEs) due to agents administered more than 3 weeks earlier
- Antineoplastic therapy with biological agents within 2 weeks before day 1 or within 5 drug half-lives (t½) prior to first dose, whichever time period is longer
- Concomitant antineoplastic therapies including chemotherapy, radiotherapy, or biological agents during the study
- Treatment with another investigational drug during the study or within 3 weeks before day 1 or within 5 drug half-live (t½) prior to first dose, whichever time period is longer
- Treatment with BT062 in previous studies
- Major surgery within 4 weeks before day 1 (this does not include placement of vascular access device or tumor biopsies)
Show all 16Show fewer
- Malignancy within 3 years before day 1, other than the trial indication multiple myeloma and excluding treated non-melanoma skin cancer, superficial bladder cancer, carcinoma in-situ of the cervix and prostate carcinoma ≤ Gleason Grade 6 with stable prostate specific antigen (PSA) levels
- Subjects with plasma cell leukemia (PCL)
- Subjects with deep vein thrombosis (DVT) and Pulmonary embolism (PE) within 3 months prior to day 1 treatment
- Severe infections necessitating use of antibiotics / antivirals during the screening period
- Clinically relevant active infection including active hepatitis B or C or human immunodeficiency virus (HBV, HCV, or HIV) or any other concurrent disease
- Acute or relevant abnormalities in electrocardiogram (ECG)
- Significant cardiac disease
- Pregnant or breast-feeding
- Positive serum or urine pregnancy test
- Hypersensitivity to the active substance or to any of the excipients for study drug BT062, or history of severe allergic or anaphylactic reaction to therapeutic proteins (e.g. reaction to vaccination or to biological therapy)
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Emory University Winship Cancer Institute
Atlanta, Georgia, 30322
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
The University of Chicago
Chicago, Illinois, 60637
City of Hope
Duarte, California, 91010
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Mayo Clinic
Jacksonville, Florida, 32224
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Mount Sinai Medical Center
New York, New York, 10029
Memorial Healthcare System
Pembroke Pines, Florida, 33028
University of Texas Health Science Center
San Antonio, Texas, 78229
About this study
Official title: A Phase I/IIa Multi-dose Escalation Study of BT062 in Combination With Lenalidomide or Pomalidomide and Dexamethasone in Subjects With Relapsed or Relapsed/Refractory Multiple Myeloma
The purpose of this study is to test safety and anti-tumor activity of BT062 in combination with lenalidomide and dexamethasone to define the best doses for treating patients with relapsed and refractory multiple myeloma.
Read the detailed description
BT062 is an antibody-drug conjugate designed to bind and destroy Myeloma cells. The study drug is being given in multiple doses with standard Multiple Myeloma treatments, lenalidomide and dexamethasone, to test how well the treatments are tolerated and work together. This study is a dose escalation study with the purpose to find out the highest dose of BT062 that a subject can tolerate in combination with lenalidomide and dexamethasone.
- Conditions
- Multiple Myeloma
- Being tested
- BT062 , intravenous administration
- Keywords
- Combination, 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.
BT062 , intravenous administrationDrug
Also called Indatuximab Ravtansine
Dose escalation to determine dose limiting toxicities (DLTs) and/or the maximum tolerated dose (MTD)/recommended Phase II dose (RPTD) of BT062 in combination with lenalidomide/dexamethasone
| Study group | Role | What they receive |
|---|---|---|
| BT062 | Experimental | BT062 administered intravenously on days 1, 8 and 15 of each 28-day cycle, and lenalidomide or pomalidomide and dexamethasone administered orally to subjects with relapsed or relapsed/refractory MM Receives: Drug: BT062 , intravenous administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of optimal dose of BT062 (Phase I part)
The Phase I part will follow a standard dose escalation design with at least 3 patients per dose level to define optimal dose of BT062 in combination with lenalidomide/dexamethasone. Optimal dose will be defined by dose limiting toxicities (DLT) observed during Cycle 1 (28 days).
Measured: 6 months
Evaluation of response (Phase IIa part)
Response to treatment with optimal dose of BT062 (defined in Phase I part) in combination with lenalidomide/dexamethasone or pomalidomide/dexamethasone will be evaluated at baseline and at start of each Cycle (every 28 days). Response evaluation will be primarily based on assessment of M-protein and serum free light chains. If clinically required bone marrow analysis, plasmacytoma evaluation, and skeletal survey will be performed.
Measured: 18 months
Secondary outcomes (4)
Qualitative toxicities of BT062 in combination with lenalidomide/dexamethasone or pomalidomide/dexamethasone
Safety will be assessed at each visit by incidence of adverse events and by clinically significant changes in the patients physical examination, vital signs, and clinically laboratory results
Measured: 24 months
Pharmacokinetics of BT062 in combination with lenalidomide/dexamethasone or pomalidomide/dexamethasone
Pharmacokinetic parameters will be assessed from plasma by measuring intact BT062 and free maytansinoid (DM4)
Measured: 24 months
Assessment of Time To Event end points
Based on the response evaluation, the following Time To Event end points will be evaluated: Time To Progression, Progression Free Survival, Time To Next Treatment, Duration Of Response, Overall survival.
Measured: 24 months
Quantitative toxicities of BT062 in combination with lenalidomide/dexamethasone or pomalidomide/dexamethasone
Safety will be assessed at each visit by incidence of adverse events and by clinically significant changes in the patients physical examination, vital signs, and clinically laboratory results
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2012 (estimated)
- Study start3 Jul 2012
- Primary completion30 Oct 2018
- Study completion30 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotest Pharmaceuticals Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biotest
- Responsible party
- Sponsor
- Investigators
- Kenneth C Anderson, MD, Study director, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01638936
- Sponsor's protocol ID
- 983
- Status last verified
- Jul 2019
- First submitted
- 8 Mar 2012
- Last updated
- 23 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kelly KR, Ailawadhi S, Siegel DS, Heffner LT, Somlo G, Jagannath S, Zimmerman TM, Munshi NC, Madan S, Chanan-Khan A, Lonial S, Chandwani S, Minasyan A, Ruehle M, Barmaki-Rad F, Abdolzade-Bavil A, Rharbaoui F, Herrmann-Keiner E, Haeder T, Wartenberg-Demand A, Anderson KC. Indatuximab ravtansine plus dexamethasone with lenalidomide or pomalidomide in relapsed or refractory multiple myeloma: a multicentre, phase 1/2a study. Lancet Haematol. 2021 Nov;8(11):e794-e807. doi: 10.1016/S2352-3026(21)00208-8. Epub 2021 Sep 13.
PubMed 34529955
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIa Multi-dose Escalation Study of BT062 in Combination With Lenalidomide or Pomalidomide and Dexamethasone in Subjects With Relapsed or Relapsed/Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT01638936
- Acronym / sponsor ID
- 983
- Conditions
- Multiple Myeloma
- Keywords
- Combination, Multiple Myeloma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Biotest Pharmaceuticals CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Biotest
- Study start
- 3 Jul 2012 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 12 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test safety and anti-tumor activity of BT062 in combination with lenalidomide and dexamethasone to define the best doses for treating patients with relapsed and refractory multiple myeloma.
Detailed description
BT062 is an antibody-drug conjugate designed to bind and destroy Myeloma cells. The study drug is being given in multiple doses with standard Multiple Myeloma treatments, lenalidomide and dexamethasone, to test how well the treatments are tolerated and work together. This study is a dose escalation study with the purpose to find out the highest dose of BT062 that a subject can tolerate in combination with lenalidomide and dexamethasone.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BT062 | Experimental | Drug: BT062 , intravenous administrationBT062 administered intravenously on days 1, 8 and 15 of each 28-day cycle, and lenalidomide or pomalidomide and dexamethasone administered orally to subjects with relapsed or relapsed/refractory MM |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Diagnosis of active Multiple Myeloma according to the International Myeloma Working Group (IMWG) diagnostic criteria
- Relapsed or relapsed/refractory progressive Multiple Myeloma
- Subjects who failed at least one prior therapy (BT062/Len/dex)
- Subjects who failed at least two prior therapy (BT062/Pom/dex)
- Subjects age ≥18 years
Key exclusion criteria (16 listed)
- Chemotherapy or radiotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to day 1 or those who have not recovered from adverse events (AEs) due to agents administered more than 3 weeks earlier
- Antineoplastic therapy with biological agents within 2 weeks before day 1 or within 5 drug half-lives (t½) prior to first dose, whichever time period is longer
- Concomitant antineoplastic therapies including chemotherapy, radiotherapy, or biological agents during the study
- Treatment with another investigational drug during the study or within 3 weeks before day 1 or within 5 drug half-live (t½) prior to first dose, whichever time period is longer
- Treatment with BT062 in previous studies
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 |
|---|---|---|
| BT062 , intravenous administrationAlso: Indatuximab RavtansineDose escalation to determine dose limiting toxicities (DLTs) and/or the maximum tolerated dose (MTD)/recommended Phase II dose (RPTD) of BT062 in combination with lenalidomide/dexamethasone | Drug | BT062 |
Primary outcome
Determination of optimal dose of BT062 (Phase I part)
Time frame: 6 months
The Phase I part will follow a standard dose escalation design with at least 3 patients per dose level to define optimal dose of BT062 in combination with lenalidomide/dexamethasone. Optimal dose will be defined by dose limiting toxicities (DLT) observed during Cycle 1 (28 days).
Evaluation of response (Phase IIa part)
Time frame: 18 months
Response to treatment with optimal dose of BT062 (defined in Phase I part) in combination with lenalidomide/dexamethasone or pomalidomide/dexamethasone will be evaluated at baseline and at start of each Cycle (every 28 days). Response evaluation will be primarily based on assessment of M-protein and serum free light chains. If clinically required bone marrow analysis, plasmacytoma evaluation, and skeletal survey will be performed.
4 secondary outcomes
Qualitative toxicities of BT062 in combination with lenalidomide/dexamethasone or pomalidomide/dexamethasone
Time frame: 24 months
Pharmacokinetics of BT062 in combination with lenalidomide/dexamethasone or pomalidomide/dexamethasone
Time frame: 24 months
Assessment of Time To Event end points
Time frame: 24 months
Quantitative toxicities of BT062 in combination with lenalidomide/dexamethasone or pomalidomide/dexamethasone
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
- Derived from this study: PubMed 34529955Kelly KR, Ailawadhi S, Siegel DS, Heffner LT, Somlo G, Jagannath S, Zimmerman TM, Munshi NC, Madan S, Chanan-Khan A, Lonial S, Chandwani S, Minasyan A, Ruehle M, Barmaki-Rad F, Abdolzade-Bavil A, Rharbaoui F, Herrmann-Keiner E, Haeder T, Wartenberg-Demand A, Anderson KC. Indatuximab ravtansine plus dexamethasone with lenalidomide or pomalidomide in relapsed or refractory multiple myeloma: a multicentre, phase 1/2a study. Lancet Haematol. 2021 Nov;8(11):e794-e807. doi: 10.1016/S2352-3026(21)00208-8. Epub 2021 Sep 13.
Related trials for Multiple Myeloma
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.
Kenneth C Anderson, MD study director
Dana-Farber Cancer Institute
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BT062 , intravenous administration in people with Multiple Myeloma, run by Biotest Pharmaceuticals Corporation at 10 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 11 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 23 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 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 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?
Determination of optimal dose of BT062 (Phase I part) (time frame: 6 months). The study lists 2 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 NCT01638936, which also lists 1 linked publication.
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 23 Jul 2019.