Trial record 1 of 1 for:
Daratumumab in Combination with Bortezomib and Dexamethasone in Patients with Relapsed Multiple Myeloma
Daratumumab in Combination With Bortezomib and Dexamethasone in Relapsed or Refractory Multiple Myeloma
This study is not yet open for participant recruitment.
Verified June 2012 by Genmab
Sponsor:
Genmab
Information provided by (Responsible Party):
Genmab
ClinicalTrials.gov Identifier:
NCT01620879
First received: June 6, 2012
Last updated: June 20, 2012
Last verified: June 2012
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Purpose
The purpose of this study is to establish the safety profile of daratumumab when given in combination with bortezomib and dexamethasone in subjects with relapsed or refractory Multiple Myeloma.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma |
Drug: Daratumumab Drug: bortezomib Drug: dexamethasone |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-label, International, Multicenter, Dose Escalating Phase I/II Trial Investigating the Safety of Daratumumab in Combination With Bortezomib and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma |
Resource links provided by NLM:
MedlinePlus related topics:
Multiple Myeloma
Drug Information available for:
Dexamethasone
Dexamethasone acetate
Dexamethasone sodium phosphate
Bortezomib
U.S. FDA Resources
Further study details as provided by Genmab:
Primary Outcome Measures:
- Establish the safety profile of daratumumab when given in combination with bortezomib and dexamethasone [ Time Frame: Last patient Last treatment of Part 2 - 24 weeks after initiation of treatment. ] [ Designated as safety issue: Yes ]Frequency and intensity of adverse events and laboratory measurements
Secondary Outcome Measures:
- Evaluate the efficacy of daratumumab when given in combination with bortezomib and dexamethasone [ Time Frame: Last patient Last treatment of Part 2 - 24 weeks after initiation of treatment. ] [ Designated as safety issue: No ]Response evaluation in accordance to International Myeloma Workshop Consensus Panel 1 (Rajkumar et al, Blood 2011)
- PK profile of daratumumab [ Time Frame: Last patient Last treatment of Part 2 - 24 weeks after initiation of treatment. ] [ Designated as safety issue: No ]PK characteristics of daratumumab when given in combination with bortezomib and dexamethasone. Individual patient PK profiles and PK-parameters will be estimated.
| Estimated Enrollment: | 50 |
| Study Start Date: | June 2012 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: daratumumab |
Drug: Daratumumab
Part I (dose escalation): Daratumumab will be administered in 21-day cycles. For the first 2 cycles (6 weeks), administration of daratumumab will be weekly . In Cycles 3 through 8 (18 weeks), daratumumab will be administered on Days 1 and 11 of each 21-day cycle. Part 2: same as part I with dose as defined in Part I IV administration day 1, 4, 8 and 11 in 21 day cycles.
Drug: dexamethasone
in combination with the daratumumab/bortezomib treatment.
|
Detailed Description:
The study is conducted in two parts. The dose escalation portion of the trial (Part 1) subjects are enrolled into cohorts at increasing dose levels of daratumumab in combination with bortezomib and dexemethasone in 21 day treatment cycles. Part 2, the cohort expansion part of the trial, will further explore the maximum tolerated dose (MTD) (or the maximum tested dose) of daratumumab as determined in Part 1.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- (Part 1) Have MM after receiving a minimum of 2 and a maximum of 4 prior lines of therapy and be eligible for treatment with bortezomib and dexamethasone.
- (Part 2) Have relapsed MM after receiving a minimum of 1 and a maximum of 3 prior lines of therapy and be eligible for treatment with bortezomib and dexamethasone.
- Be older than or be 18 years of age.
- ECOG performance status (0-2).
- Following receipt of verbal and written information about the study, the patient must provide signed informed consent before any study related activity is carried out.
Exclusion Criteria:
- Have previously received an allogenic stem cell transplant.
- Have received autologous stem cell transplant within 12 weeks before the first infusion.
- Have received chemotherapy or any experimental drug or therapy within 3 weeks before the first infusion.
- Have received bortezomib, lenalidomide, or thalidomide within 2 weeks before the first infusion.
- Have multiple myeloma that is refractory to bortezomib, defined as not having a minimum clinical response of MR for at least 2 months during the last treatment with bortezomib.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01620879
Contacts
| Contact: Franca Maria Riganti, Senior Project Manager | franca-maria.riganti@incresearch.com | |
| Contact: Ans Kramer, Project Manager | Ans.Kramer@INCResearch.com |
Locations
| Denmark | |
| Vejle sygehus | Not yet recruiting |
| Vejle, Denmark, DK-7100 | |
| Contact: Torben Plesner, MD | |
| Principal Investigator: Torben Plenser, MD | |
Sponsors and Collaborators
Genmab
Investigators
| Principal Investigator: | Antonio Palumbo, MD | Department of Hematology, University of Torino |
| Principal Investigator: | Paul Richardson, MD | Dana Farber |
More Information
No publications provided
| Responsible Party: | Genmab |
| ClinicalTrials.gov Identifier: | NCT01620879 History of Changes |
| Other Study ID Numbers: | GEN504 |
| Study First Received: | June 6, 2012 |
| Last Updated: | June 20, 2012 |
| Health Authority: | United States: Food and Drug Administration Denmark: Danish Medicines Agency France: L’Agence nationale de sécurité du médicament et des produits de santé Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) United Kingdom: Medicines and Healthcare Products Regulatory Agency Italy: The Italian Medicines Agency |
Additional relevant MeSH terms:
|
Multiple Myeloma Dexamethasone acetate Dexamethasone Dexamethasone 21-phosphate Bortezomib BB 1101 Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases |
Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Antibodies, Monoclonal Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents Glucocorticoids |
ClinicalTrials.gov processed this record on May 19, 2013