Dalteparin, Lenalidomide, and Low-Dose Dexamethasone in Treating Patients With Previously Untreated Multiple Myeloma

NCT01518465 | Terminated Phase 2 DMC

• 2 other identifiers: 16M-11-1NCI-2011-03784
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized pilot phase II trial studies how well giving dalteparin, lenalidomide, and low-dose dexamethasone together works in treating patients with previously untreated multiple myeloma. Anticoagulants, such as dalteparin, may help prevent blood clots from forming in patients being treated with lenalidomide and dexamethasone for multiple myeloma. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving dalteparin, lenalidomide, and dexamethasone together may be an effective treatment for multiple myeloma

Conditions

Stage I Multiple Myeloma; Stage II Multiple Myeloma; Stage III Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Number of patients who experienced grade 4 hemorrhage regardless of attribution, or grade 3 hemorrhage that is possibly, probably, or definitely attributable to dalteparin (Arm II)

  Up to 2 years

Secondary Outcomes (1)

• Toxicities observed at each dose level, in terms of type (organ affected, laboratory determination), severity (by Common Toxicity Criteria [CTC])

  Up to 2 years

Study Arms (2)

Arm I (5000 IU dalteparin)

EXPERIMENTAL

Patients receive a prophylactic dose of dalteparin SC on days 1-28; lenalidomide PO on days 1-21; and low-dose dexamethasone PO on days 1, 8, 15, and 22.

Drug: dalteparin; Drug: lenalidomide; Drug: dexamethasone; Other: laboratory biomarker analysis

Arm II (200 IU/kg dalteparin)

EXPERIMENTAL

Patients receive a therapeutic dose of dalteparin SC on days 1-21 and lenalidomide PO and low-dose dexamethasone PO as in Arm I.

Drug: dalteparin; Drug: lenalidomide; Drug: dexamethasone; Other: laboratory biomarker analysis

Interventions

dalteparin DRUG

Given SC

Also known as: DAL, dalteparin sodium, Fragmin

Arm I (5000 IU dalteparin); Arm II (200 IU/kg dalteparin)

lenalidomide DRUG

Given PO

Also known as: CC-5013, IMiD-1, Revlimid

Arm I (5000 IU dalteparin); Arm II (200 IU/kg dalteparin)

dexamethasone DRUG

Given PO

Also known as: Aeroseb-Dex, Decaderm, Decadron, DM, DXM

Arm I (5000 IU dalteparin); Arm II (200 IU/kg dalteparin)

laboratory biomarker analysis OTHER

Correlative studies

Arm I (5000 IU dalteparin); Arm II (200 IU/kg dalteparin)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have a diagnosis of active MM requiring treatment, as diagnosed by a bone marrow biopsy within 8 weeks prior to study enrollment
• Patients must not have received any previous treatment for MM (localized radiation therapy or single agent pulse steroid therapy for acute MM crises is permitted)
• Life expectancy of greater than 12 weeks
• Eastern Cooperative Oncology Group (ECOG) performance status \< 2 (Karnofsky \>= 50%)
• Total bilirubin \< 1.5 x upper limit of normal (ULN)
• Transaminases (aspartate aminotransferase \[AST\]/alanine aminotransferase \[ALT\]) \< 2.5 x ULN
• Alkaline phosphatase \< 2.5 ULN
• Platelets \>= 75,000 cells/mm3
• Hemoglobin \>= 8.0 g/dL
• Absolute neutrophil count (ANC) \> 1,000 cells/mm3 NOTE: Patients with platelet count \< 75,000 or hemoglobin \< 8.0 g/dl,or ANC \<1,000 cell/mm3 secondary to extensive bone marrow disease can be enrolled at Principal Investigator's (PI) discretion with appropriate transfusion and/or cytokine support
• Creatinine =\< 2.5 mg/dL (=\< 200 mmol/L) or creatinine clearance \> 30 ml/min (as calculated by the Cockcroft-Gault formula)
• Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10-14 days and again within 24 hours prior to prescribing lenalidomide for Cycle 1 and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy
• All study participants must be registered into the mandatory RevAssist program, and be willing and able to comply with the requirements of RevAssist
• Willingness and ability to sign informed consent for the clinical trial

You may not qualify if:

• Patients who have had any prior chemotherapy for MM; with the exception of pulse steroids for any myeloma-related acute events
• Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational
• Pregnant or lactating women
• Active serious infections uncontrolled by antibiotics at the time of treatment initiation
• Inability to give 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
• Failure to comply with birth control methods as described above
• Any serious medical or psychiatric condition or reason that, in the PI's opinion, makes the patient unsuitable to participate in this clinical trial
• Known to be human immunodeficiency virus (HIV) positive (if the status of HIV is not known and patient is not at risk, as determined by the PI, then the patient will not be specifically tested for HIV); HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with lenalidomide and/or dalteparin. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy
• Diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer (organ-confined, early stage disease) after curative therapy
• Patients with M protein \>6 gm/dl prior to starting treatment will be excluded from the initial "run-in" cohort on both arms of the study, but will be eligible for the subsequent enrollment of patients who do not have a run-in phase with dalteparin

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator
• Celgene Corporation: collaborator

Study Sites (1)

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Dalteparin; Lenalidomide; Dexamethasone; Calcium Dobesilate

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Ann Mohrbacher, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2012
• First Posted: January 26, 2012
• Study Start: January 9, 2012
• Primary Completion: December 31, 2016
• Study Completion: October 31, 2017
• Last Updated: November 29, 2017

Record last verified: 2017-11

Locations

US (1)